Viewing Study NCT03698669

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
Ignite Creation Date: 2025-12-24 @ 11:03 PM
Ignite Modification Date: 2026-02-25 @ 7:22 PM
Study NCT ID: NCT03698669
Status: COMPLETED
Last Update Posted: 2025-06-26
First Post: 2018-10-02
Is Gene Therapy: True
Has Adverse Events: True
Brief Title: Treating Chronic Pain in Buprenorphine Patients in Primary Care Settings
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009293', 'term': 'Opioid-Related Disorders'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D000079524', 'term': 'Narcotic-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mdstein@bu.edu', 'phone': '617 358 1956', 'title': 'Michael Stein, MD', 'organization': 'Boston University'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data were collected over the course of the 12-month study period.', 'eventGroups': [{'id': 'EG000', 'title': "Treating Opioid Patients' Pain and Sadness (TOPPS)", 'description': 'TOPPS, consists of three main components: (1) psychoeducation about pain, depression, opioid use, their interactions, and the maintaining role of avoidance; (2) coaching in being an informed, activated patient (based in part on the chronic care model and on approaches to self-management of chronic illness); and (3) behavioral activation to increase engagement in meaningful activities.', 'otherNumAtRisk': 82, 'deathsNumAtRisk': 82, 'otherNumAffected': 40, 'seriousNumAtRisk': 82, 'deathsNumAffected': 1, 'seriousNumAffected': 8}, {'id': 'EG001', 'title': 'Health Education (HE)', 'description': "Participants randomized to the control HE condition are offered six telephone sessions led by the Behavioral Health Specialists. The first health session is around nutrition. At the remaining sessions, participants choose from a menu of topics, including: a second session on nutrition; germs, colds and the flu; preventing cancer; diabetes; protecting your heart; getting a good night's sleep; complementary and alternative medicine; caffeine, or physical activity.", 'otherNumAtRisk': 81, 'deathsNumAtRisk': 81, 'otherNumAffected': 54, 'seriousNumAtRisk': 81, 'deathsNumAffected': 1, 'seriousNumAffected': 15}], 'otherEvents': [{'term': 'Tooth abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Leg infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Shingles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rib pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Withdrawal symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Paranoia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Shoulder pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hand surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ER visit- diabetes symptom management', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Tooth pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'RSV', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Stomach virus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chest congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Laryngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Blood clot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fractured nose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sunburn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fractured wrist', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Motor vehicle accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infection in arm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Kidney stones', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bronchospasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neck pain due to ablation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Umbilical hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hip dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Toe infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bleach in wound', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Stroke symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Eye disorder- other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'COVID-19 infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Allergic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Toe fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Difficulty breathing- asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sinus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bursitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Foot wound', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Folliculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Facial wound', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bladder infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Strep throat', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ear infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Injury from fight', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Stomach pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gallstone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Swollen lymph nodes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ankle sprain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Facial abscess/cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hip pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cyst on hand', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hand fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Finger wound', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Knee infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Forearm strain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vaginal cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Hospitalization due to overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization due to hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization- gallbladder removal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization due to sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization due to lung infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization due to myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization due to pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization- psychiatric', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization due to severe back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization due to kidney stone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization- difficulty breathing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization due to fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization due to endocarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization for flu symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization due to infection in foot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization due to pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization due to lung inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization for substance use treatment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization due to staph infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pain Interference Based on the Brief Pain Inventory', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': "Treating Opioid Patients' Pain and Sadness (TOPPS)", 'description': 'TOPPS, consists of three main components: (1) psychoeducation about pain, depression, opioid use, their interactions, and the maintaining role of avoidance; (2) coaching in being an informed, activated patient (based in part on the chronic care model and on approaches to self-management of chronic illness); and (3) behavioral activation to increase engagement in meaningful activities.'}, {'id': 'OG001', 'title': 'Health Education (HE)', 'description': "Participants randomized to the control HE condition are offered six telephone sessions led by the Behavioral Health Specialists. The first health session is around nutrition. At the remaining sessions, participants choose from a menu of topics, including: a second session on nutrition; germs, colds and the flu; preventing cancer; diabetes; protecting your heart; getting a good night's sleep; complementary and alternative medicine; caffeine, or physical activity."}], 'classes': [{'categories': [{'measurements': [{'value': '5.01', 'groupId': 'OG000', 'lowerLimit': '4.54', 'upperLimit': '5.47'}, {'value': '4.67', 'groupId': 'OG001', 'lowerLimit': '4.19', 'upperLimit': '5.47'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '3 Months', 'description': 'The Brief Pain Inventory Interference Scale (BPI-I) will be used to capture the domain of pain interference with physical and psychosocial functioning. The pain interference subscale includes 7 questions assessing the degree to which pain interferes with general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life using a 0-to-10 numeric rating score. For interference items, 0 represents "does not interfere" and 10 indicates "interferes completely."', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'These numbers represent those with non-missing data on the BPI-Interference subscale at 3 months.'}, {'type': 'PRIMARY', 'title': 'Pain Severity Based on the Brief Pain Inventory', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': "Treating Opioid Patients' Pain and Sadness (TOPPS)", 'description': 'TOPPS, consists of three main components: (1) psychoeducation about pain, depression, opioid use, their interactions, and the maintaining role of avoidance; (2) coaching in being an informed, activated patient (based in part on the chronic care model and on approaches to self-management of chronic illness); and (3) behavioral activation to increase engagement in meaningful activities.'}, {'id': 'OG001', 'title': 'Health Education (HE)', 'description': "Participants randomized to the control HE condition are offered six telephone sessions led by the Behavioral Health Specialists. The first health session is around nutrition. At the remaining sessions, participants choose from a menu of topics, including: a second session on nutrition; germs, colds and the flu; preventing cancer; diabetes; protecting your heart; getting a good night's sleep; complementary and alternative medicine; caffeine, or physical activity."}], 'classes': [{'categories': [{'measurements': [{'value': '5.17', 'groupId': 'OG000', 'lowerLimit': '4.75', 'upperLimit': '5.58'}, {'value': '5.02', 'groupId': 'OG001', 'lowerLimit': '4.65', 'upperLimit': '5.39'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '3 Months', 'description': 'Pain severity will be measured by the Visual Analogue Scale (VAS) presented as a 100-mm horizontal line on which the patient\'s pain intensity is represented by a point between the extremes of "no pain at all" and "worst pain imaginable." Participants will indicate "average" pain in the last week. Scores range between 0 and 10.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'These numbers represent those with non-missing data on the BPI at 3 months.'}, {'type': 'PRIMARY', 'title': 'Depression Based on the Patient Health Questionnaire-9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': "Treating Opioid Patients' Pain and Sadness (TOPPS)", 'description': 'TOPPS, consists of three main components: (1) psychoeducation about pain, depression, opioid use, their interactions, and the maintaining role of avoidance; (2) coaching in being an informed, activated patient (based in part on the chronic care model and on approaches to self-management of chronic illness); and (3) behavioral activation to increase engagement in meaningful activities.'}, {'id': 'OG001', 'title': 'Health Education (HE)', 'description': "Participants randomized to the control HE condition are offered six telephone sessions led by the Behavioral Health Specialists. The first health session is around nutrition. At the remaining sessions, participants choose from a menu of topics, including: a second session on nutrition; germs, colds and the flu; preventing cancer; diabetes; protecting your heart; getting a good night's sleep; complementary and alternative medicine; caffeine, or physical activity."}], 'classes': [{'categories': [{'measurements': [{'value': '10.91', 'groupId': 'OG000', 'lowerLimit': '9.87', 'upperLimit': '11.95'}, {'value': '9.21', 'groupId': 'OG001', 'lowerLimit': '8.13', 'upperLimit': '10.30'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 Months', 'description': 'The Patient Health Questionnaire (PHQ-9) will be used to measure depression severity and suicidality. It is the major depressive disorder module of the full PHQ. Scores range from 0-27, with scores less than or equal to 4 suggesting minimal depression, scores from 5 to 9 indicating mild depression, 10 to 14 indicating moderately depression, 15 to 19 reflecting moderately severe depression, and scores greater than 20 indicating severe depression.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Rates of Buprenorphine Treatment Retention', 'timeFrame': 'Month 12', 'description': 'Using clinical records at the recruitment sites, we will record the date of last buprenorphine treatment visit and calculate the treatment retention rates up to 12 months.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2025-09'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': "Treating Opioid Patients' Pain and Sadness (TOPPS)", 'description': 'TOPPS, consists of three main components: (1) psychoeducation about pain, depression, opioid use, their interactions, and the maintaining role of avoidance; (2) coaching in being an informed, activated patient (based in part on the chronic care model and on approaches to self-management of chronic illness); and (3) behavioral activation to increase engagement in meaningful activities.'}, {'id': 'FG001', 'title': 'Health Education (HE)', 'description': "Participants randomized to the control HE condition are offered six telephone sessions led by the Behavioral Health Specialists. The first health session is around nutrition. At the remaining sessions, participants choose from a menu of topics, including: a second session on nutrition; germs, colds and the flu; preventing cancer; diabetes; protecting your heart; getting a good night's sleep; complementary and alternative medicine; caffeine, or physical activity."}], 'periods': [{'title': 'Allocation', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '82'}, {'groupId': 'FG001', 'numSubjects': '81'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '82'}, {'groupId': 'FG001', 'numSubjects': '81'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Completed 3 Month Assessment', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '82'}, {'groupId': 'FG001', 'numSubjects': '81'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}, {'groupId': 'FG001', 'numSubjects': '65'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '16'}]}]}, {'title': 'Completed 6 Month Assessment', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '82'}, {'groupId': 'FG001', 'numSubjects': '81'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '66'}, {'groupId': 'FG001', 'numSubjects': '64'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '17'}]}]}, {'title': 'Completed 9 Month Assessment', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '82'}, {'groupId': 'FG001', 'numSubjects': '81'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '63'}, {'groupId': 'FG001', 'numSubjects': '60'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '21'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'BG000'}, {'value': '81', 'groupId': 'BG001'}, {'value': '163', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': "Treating Opioid Patients' Pain and Sadness (TOPPS)", 'description': 'TOPPS, consists of three main components: (1) psychoeducation about pain, depression, opioid use, their interactions, and the maintaining role of avoidance; (2) coaching in being an informed, activated patient (based in part on the chronic care model and on approaches to self-management of chronic illness); and (3) behavioral activation to increase engagement in meaningful activities.'}, {'id': 'BG001', 'title': 'Health Education (HE)', 'description': "Participants randomized to the control HE condition are offered six telephone sessions led by the Behavioral Health Specialists. The first health session is around nutrition. At the remaining sessions, participants choose from a menu of topics, including: a second session on nutrition; germs, colds and the flu; preventing cancer; diabetes; protecting your heart; getting a good night's sleep; complementary and alternative medicine; caffeine, or physical activity."}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '45.5', 'spread': '10.8', 'groupId': 'BG000'}, {'value': '43.7', 'spread': '10.4', 'groupId': 'BG001'}, {'value': '44.6', 'spread': '10.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '86', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '67', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '141', 'groupId': 'BG002'}]}]}, {'title': 'African American', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '82', 'groupId': 'BG000'}, {'value': '81', 'groupId': 'BG001'}, {'value': '163', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Pain Interference Based on the Brief Pain Inventory', 'classes': [{'categories': [{'measurements': [{'value': '6.04', 'spread': '1.57', 'groupId': 'BG000'}, {'value': '6.02', 'spread': '1.67', 'groupId': 'BG001'}, {'value': '6.03', 'spread': '1.61', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "Brief Pain Inventory- Interference Scale. Subscale of the Brief Pain Inventory. Measures pain's interference with physical and psychosocial functioning.\n\nRanges from 0-10, with higher numbers indicating greater pain interference.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Pain Severity Based on the Brief Pain Inventory', 'classes': [{'categories': [{'measurements': [{'value': '5.68', 'spread': '1.66', 'groupId': 'BG000'}, {'value': '5.68', 'spread': '1.66', 'groupId': 'BG001'}, {'value': '5.68', 'spread': '1.66', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Participants will indicate "average" pain in the last week. Scores range from 0-10 with higher scores indicating greater pain severity.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Patient Health Questionnaire- 9 Score', 'classes': [{'categories': [{'measurements': [{'value': '12.33', 'spread': '5.07', 'groupId': 'BG000'}, {'value': '12.04', 'spread': '4.96', 'groupId': 'BG001'}, {'value': '12.18', 'spread': '5.00', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Objectifies degree of depression severity.\n\nHigher scores are indicative of higher levels of depressive symptoms.\n\nScores range from 0-27.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-04-08', 'size': 756186, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-04-28T13:57', 'hasProtocol': True}, {'date': '2023-09-24', 'size': 899238, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-02-23T08:50', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 163}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-08-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2024-12-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-09', 'studyFirstSubmitDate': '2018-10-02', 'resultsFirstSubmitDate': '2025-04-28', 'studyFirstSubmitQcDate': '2018-10-04', 'lastUpdatePostDateStruct': {'date': '2025-06-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-06-09', 'studyFirstPostDateStruct': {'date': '2018-10-09', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-06-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Interference Based on the Brief Pain Inventory', 'timeFrame': '3 Months', 'description': 'The Brief Pain Inventory Interference Scale (BPI-I) will be used to capture the domain of pain interference with physical and psychosocial functioning. The pain interference subscale includes 7 questions assessing the degree to which pain interferes with general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life using a 0-to-10 numeric rating score. For interference items, 0 represents "does not interfere" and 10 indicates "interferes completely."'}, {'measure': 'Pain Severity Based on the Brief Pain Inventory', 'timeFrame': '3 Months', 'description': 'Pain severity will be measured by the Visual Analogue Scale (VAS) presented as a 100-mm horizontal line on which the patient\'s pain intensity is represented by a point between the extremes of "no pain at all" and "worst pain imaginable." Participants will indicate "average" pain in the last week. Scores range between 0 and 10.'}, {'measure': 'Depression Based on the Patient Health Questionnaire-9', 'timeFrame': '3 Months', 'description': 'The Patient Health Questionnaire (PHQ-9) will be used to measure depression severity and suicidality. It is the major depressive disorder module of the full PHQ. Scores range from 0-27, with scores less than or equal to 4 suggesting minimal depression, scores from 5 to 9 indicating mild depression, 10 to 14 indicating moderately depression, 15 to 19 reflecting moderately severe depression, and scores greater than 20 indicating severe depression.'}], 'secondaryOutcomes': [{'measure': 'Rates of Buprenorphine Treatment Retention', 'timeFrame': 'Month 12', 'description': 'Using clinical records at the recruitment sites, we will record the date of last buprenorphine treatment visit and calculate the treatment retention rates up to 12 months.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Depression', 'Pain', 'Cognitive behavioral therapy (CBT)', 'Buprenorphine', 'Behavioral health specialist (BHS)', 'Primary care provider (PCP)'], 'conditions': ['Opioid-Related Disorders']}, 'referencesModule': {'references': [{'pmid': '38878997', 'type': 'BACKGROUND', 'citation': "Stein MD, Bendiks S, Karzhevsky S, Pierce C, Dunn A, Majeski A, Herman DS, Weisberg RB. Study protocol for the Treating Opioid Patients' Pain and Sadness (TOPPS) study - A randomized control trial to lower depression and chronic pain interference, and increase care retention among persons receiving buprenorphine. Contemp Clin Trials. 2024 Aug;143:107608. doi: 10.1016/j.cct.2024.107608. Epub 2024 Jun 13."}, {'pmid': '39488941', 'type': 'DERIVED', 'citation': 'Haley DF, Stein MD, Bendiks S, Karzhevsky S, Pierce C, Dunn A, Herman DS, Anderson B, Weisberg RB. Associations of discomfort intolerance, discomfort avoidance, and cannabis and alcohol use among persons with chronic pain receiving prescription buprenorphine for opioid use disorder. Drug Alcohol Depend. 2024 Dec 1;265:112472. doi: 10.1016/j.drugalcdep.2024.112472. Epub 2024 Oct 24.'}]}, 'descriptionModule': {'briefSummary': "Treating Opioid Patients' Pain and Sadness (TOPPS) focuses on the relationship of pain, depression, opioid and other substance misuse, and functioning. It has a structured agenda, uses behavioral activation, involves explicit and ongoing psychoeducation, and includes a behavioral health specialist (BHS) trained extensively in the nature of pain and opioid misuse, including how to assess for red flags of opioid relapse. Devised specifically for primary care patients receiving buprenorphine, TOPPS is collaborative (PCP, BHS, and patient) and focuses on pain and physical symptoms in order to decrease the need to turn to substance misuse to avoid pain, and to foster patient's abilities to achieve their long-term life goals. In this study, TOPPS is compared to a health education contact-control condition among 250 persons with opioid use disorder recruited from two primary care based buprenorphine programs. The investigators will provide both interventions over 3 months, and follow the patients for a total of 12 months in order to observe both short-term and longer-term effects of TOPPS.", 'detailedDescription': "Nearly 2.5 million individuals in the United States have opioid use disorder (OUD), with the vast majority (2 million) reporting abuse of prescription opioids. Patients with a history of substance use are particularly vulnerable to experiencing pain. Indeed, a large percentage of patients with OUD who receive the effective opioid agonist treatments (OAT) buprenorphine or methadone (MMT), report that pain preceded any use of addictive substances, and that the primary reason for starting opioid use was to reduce pain. Among methadone patients, 37-61% suffer from chronic pain that is often severe and interferes with daily activities. Similarly, in studies of chronic pain in buprenorphine patients, approximately 48% of patients report chronic pain. OAT recipients report far higher rates of chronic pain than the wider US population.\n\nChronic pain has been associated with negative substance use outcomes in persons receiving buprenorphine for opioid detoxification and in people receiving MMT. Providers may prioritize the treatment of substance use in OUD patients, leaving the concurrent pain untreated. Lack of treatment encourages patients to use illicit opioids for pain relief. Indeed, for persons using buprenorphine, greater pain severity in a given week was significantly associated with increased likelihood of opioid use in the following week.\n\nPain contributes to other negative outcomes. Pain is an independent risk factor for suicide including in samples of substance use disorder patients. Further, compared to MMT patients without pain, those with pain have significantly greater health problems and psychological distress. Pain, poor health, and low energy are the most commonly cited reasons that OAT patients are physically inactive. The continued physical and social problems in patients with pain influence the perception of (lack of) treatment benefits by both patients and providers.\n\nDuration of opioid agonist treatment (OAT) is a key predictor of long-term abstinence and outcomes improve across a variety of domains if patients remain in care for at least one year. Although buprenorphine is a growing ambulatory treatment, retention in care remains problematic. Across practice sites and, despite variations in visit frequency, the 12-month retention rate ranges from 50-80% with the majority of treatment drop-out occurring during the first three months of treatment. Though few studies have yet examined the role of pain, pain has been found to negatively impact buprenorphine treatment retention.\n\nStudies estimate that approximately one third to one half of MMT and buprenorphine recipients suffer from depression. Several studies have reported that opioid dependent patients with chronic pain have greater depressive symptoms and a greater probability of occupational disability compared to patients with lower level or no chronic pain. Amongst MMT patients, higher psychiatric distress is associated with lower general functioning. Methadone counselors report difficulty treating patients with chronic pain due in part to these patients' co-occurring psychiatric symptoms. In the only study of antidepressant treatment for depressed persons initiating buprenorphine, the investigators found in a secondary analysis that pain is prevalent, interferes with functioning, and its severity plateaus after one month of buprenorphine. Importantly, as with chronic pain, depressive symptoms have been associated with greater likelihood of relapse to opioid use in OAT patients. The substantial overlap of pain and depression in OAT patients suggest that functioning may improve most when depression and pain are simultaneously treated in an integrated fashion that is theoretically-based.\n\nTOPPS is a type of cognitive behavioral therapy (CBT) that consists of three main components: 1) psychoeducation about pain, depression, opioid misuse, their interaction, and the maintaining role of avoidance; 2) coaching in being an informed, activated patient; and 3) behavioral activation with a focus on acceptance. Modern behavioral activation is idiographic and responsive to each patient's unique environment, needs, and goals. The function of a behavior is analyzed, and if the function is avoidance (e.g., of social contact, personal engagement, or physical activity), the behavior is targeted for change. Patients are taught to consider behavioral options, and to choose an option inconsistent with avoidance. There is an implicit attitude of acceptance of thoughts and feelings, as behavior is not dependent on changing thoughts and feelings. Behavior activation for depression focuses on helping patients to set goals in meaningful life areas, and then to break down long-term goals into smaller weekly goals. This process is incompatible with behavioral avoidance and instead, encourages patients to approach meaningful life goals. Barriers that arise in achieving short-term goals are addressed in treatment.\n\nTOPPS focuses on the relationship of pain, depression, opioid and other substance misuse, and functioning. It has a structured agenda, uses behavioral activation, involves explicit and ongoing psychoeducation, and includes a BHS trained extensively in the nature of pain and opioid misuse and relapse. Devised specifically for primary care patients receiving buprenorphine, TOPPS is collaborative (physician, interventionist, and patient) and focuses on depression, pain and physical symptoms in order to decrease the need to turn to substance misuse to avoid pain, increase overall functioning and to foster patient's abilities to achieve their long-term life goals."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Between 18 and 65 years of age\n2. Have chronic pain, defined as pain duration for at least three months with a mean score of 4 or higher on the Brief Pain Inventory (BPI) Pain Interference Scale\n3. Pain severity of 4 or higher on a numerical rating scale (0-10) indicating "worst pain in the last week"\n4. If using an antidepressant, the dose must be stable for the previous 2 months\n5. Has received buprenorphine from the current primary care provider for at least the last month\n6. Continuing buprenorphine with no plan to taper dose for the next 12 months\n7. Score of ≥4 on Personal Health Questionnaire-9 instrument (at least "mild" depression severity)\n8. Gives informed consent to participate in the study.\n\nExclusion Criteria:\n\n1. Expected surgery in the next 3 months\n2. Pain thought to be due to cancer, infection, or inflammatory arthritis\n3. Greater than or equal to 10 days of cocaine/crack/methamphetamine use in the past month\n4. Current (past month) mania or past year psychosis as determined via Structured Clinical Interview for DSM-5 (SCID) Module\'s A and B/C\n5. Lifetime diagnosis of schizophrenia or other chronic psychotic condition as determined by the study PI\n6. Planning to stop using buprenorphine in the next 6 months\n7. Pregnancy or planned pregnancy in the next 6 months.\n8. Greater than 8 homeless nights in the past month\n9. Suicide ideation or behavior requiring immediate attention\n10. Not able to provide informed consent\n11. Not able to complete interviews in English\n12. Unable to provide names and contact information for at least two verifiable locator persons who will know where to find them in the future.\n13. Greater than or equal to 45 days without a phone in the past 3 months/no reliable access to phone\n14. Headache/migraine as the only site of pain'}, 'identificationModule': {'nctId': 'NCT03698669', 'acronym': 'TOPPS', 'briefTitle': 'Treating Chronic Pain in Buprenorphine Patients in Primary Care Settings', 'organization': {'class': 'OTHER', 'fullName': 'Boston University'}, 'officialTitle': 'Treating Chronic Pain in Buprenorphine Patients in Primary Care Settings', 'orgStudyIdInfo': {'id': 'H-38056'}, 'secondaryIdInfos': [{'id': '1R01DA045695', 'link': 'https://reporter.nih.gov/quickSearch/1R01DA045695', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': "Treating Opioid Patients' Pain and Sadness (TOPPS)", 'description': 'TOPPS, consists of three main components: (1) psychoeducation about pain, depression, opioid use, their interactions, and the maintaining role of avoidance; (2) coaching in being an informed, activated patient (based in part on the chronic care model and on approaches to self-management of chronic illness); and (3) behavioral activation to increase engagement in meaningful activities.', 'interventionNames': ["Behavioral: Treating Opioid Patients' Pain and Sadness (TOPPS)"]}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Health Education (HE)', 'description': "Participants randomized to the control HE condition are offered six telephone sessions led by the Behavioral Health Specialists. The first health session is around nutrition. At the remaining sessions, participants choose from a menu of topics, including: a second session on nutrition; germs, colds and the flu; preventing cancer; diabetes; protecting your heart; getting a good night's sleep; complementary and alternative medicine; caffeine, or physical activity.", 'interventionNames': ['Behavioral: Health Education (HE)']}], 'interventions': [{'name': "Treating Opioid Patients' Pain and Sadness (TOPPS)", 'type': 'BEHAVIORAL', 'description': 'TOPPS, consists of three main components: (1) psychoeducation about pain, depression, opioid use, their interactions, and the maintaining role of avoidance; (2) coaching in being an informed, activated patient (based in part on the chronic care model and on approaches to self-management of chronic illness); and (3) behavioral activation to increase engagement in meaningful activities.', 'armGroupLabels': ["Treating Opioid Patients' Pain and Sadness (TOPPS)"]}, {'name': 'Health Education (HE)', 'type': 'BEHAVIORAL', 'description': "Participants randomized to the control HE condition are offered six telephone sessions led by the Behavioral Health Specialists. The first health session is around nutrition. At the remaining sessions, participants choose from a menu of topics, including: a second session on nutrition; germs, colds and the flu; preventing cancer; diabetes; protecting your heart; getting a good night's sleep; complementary and alternative medicine; caffeine, or physical activity.", 'armGroupLabels': ['Health Education (HE)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02118', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Boston Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02720', 'city': 'Fall River', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Stanley Street Treatment and Resources', 'geoPoint': {'lat': 41.70149, 'lon': -71.15505}}], 'overallOfficials': [{'name': 'Michael D Stein, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Boston University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boston University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}