Ignite Creation Date:
2025-12-24 @ 11:52 PM
Ignite Modification Date:
2026-03-09 @ 4:46 AM
Study NCT ID:
NCT01590251
Status:
COMPLETED
Last Update Posted:
2015-09-25
First Post:
2012-04-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Yoga for Pain and Opioid Dependence
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059350', 'term': 'Chronic Pain'}, {'id': 'D009293', 'term': 'Opioid-Related Disorders'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D016739', 'term': 'Behavior, Addictive'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000079524', 'term': 'Narcotic-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D003192', 'term': 'Compulsive Behavior'}, {'id': 'D007175', 'term': 'Impulsive Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015013', 'term': 'Yoga'}], 'ancestors': [{'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026443', 'term': 'Spiritual Therapies'}, {'id': 'D026241', 'term': 'Exercise Movement Techniques'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-23', 'studyFirstSubmitDate': '2012-04-30', 'studyFirstSubmitQcDate': '2012-04-30', 'lastUpdatePostDateStruct': {'date': '2015-09-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-05-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain reduction', 'timeFrame': '8 weeks', 'description': 'Pain reduction will be measured by patient self-report using standard pain rating scales.'}, {'measure': 'Reduce illicit opioid use', 'timeFrame': '8 weeks', 'description': 'Reduced illicit opioid use will be measured by patient self-report and urinalysis testing.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pain', 'Addiction', 'Buprenorphine', 'Counseling', 'Methadone', 'Yoga'], 'conditions': ['Chronic Pain', 'Opioid Addiction']}, 'descriptionModule': {'briefSummary': 'This study is designed to develop an effective adjunctive treatment using yoga for chronic pain and opioid dependence.', 'detailedDescription': 'This study aims to develop an adjunctive novel treatment intervention using yoga in opioid agonist maintained patients to effectively treat the co-occurring disorders of non-malignant chronic pain and opioid dependence (POD).\n\nSpecific Aims:\n\n1\\) To conduct a pre-pilot phase with 8 patients with POD receiving opioid agonist maintenance treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age or older\n* Prescription opioid addiction or heroin addiction\n* Moderate to severe chronic pain,\n* Understands English\n\nExclusion Criteria:\n\n* Current suicide or homicide risk\n* Life threatening or unstable medical condition\n* Medical or psychiatric condition that is judged to be of clinical concern by the PI or admitting clinician\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT01590251', 'acronym': 'Yoga', 'briefTitle': 'Yoga for Pain and Opioid Dependence', 'organization': {'class': 'OTHER', 'fullName': 'Yale University'}, 'officialTitle': 'Yoga for Pain and Opioid Dependence', 'orgStudyIdInfo': {'id': '1111009292'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Yoga', 'description': 'Gentle yoga for chronic pain and opioid dependence', 'interventionNames': ['Other: Yoga']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Educational Counseling', 'description': 'Educational counseling is a didactic, lecture-discussion format to supplement the information and advice provided in opioid agonist maintenance treatment.', 'interventionNames': ['Behavioral: Educational Counseling']}], 'interventions': [{'name': 'Yoga', 'type': 'OTHER', 'description': 'Two yoga sessions per week for 8 weeks (one yoga session is instructional, the other is a practice session.', 'armGroupLabels': ['Yoga']}, {'name': 'Educational Counseling', 'type': 'BEHAVIORAL', 'description': 'One didactic session per week of approximately 50 minutes that provides information about chronic pain and substance abuse disorders.', 'armGroupLabels': ['Educational Counseling']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06519', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'MRU', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}], 'overallOfficials': [{'name': 'Declan T Barry, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yale University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yale University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}