Ignite Creation Date:
2025-12-24 @ 10:57 PM
Ignite Modification Date:
2026-01-03 @ 9:44 AM
Study NCT ID:
NCT03298269
Status:
COMPLETED
Last Update Posted:
2021-12-10
First Post:
2017-09-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Behavioral Interventions for Chronic Pain and Opioid-Related Problems
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059350', 'term': 'Chronic Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012657', 'term': 'Self-Help Groups'}], 'ancestors': [{'id': 'D009938', 'term': 'Organizations'}, {'id': 'D004472', 'term': 'Health Care Economics and Organizations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 95}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-09-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-08', 'studyFirstSubmitDate': '2017-09-26', 'studyFirstSubmitQcDate': '2017-09-28', 'lastUpdatePostDateStruct': {'date': '2021-12-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in cue-reactivity', 'timeFrame': 'Change from baseline through 8 weeks', 'description': 'Change in EEG responses during a cue-reactivity task'}, {'measure': 'Change in emotion regulation', 'timeFrame': 'Change from baseline through 8 weeks', 'description': 'Change in EEG responses during an emotion regulation task'}], 'primaryOutcomes': [{'measure': 'Change in pain symptoms', 'timeFrame': 'Change from baseline through study completion (9 months post-treatment)', 'description': 'Pain severity and interference as measured by the Brief Pain Inventory'}, {'measure': 'Change in aberrant drug-related behaviors', 'timeFrame': 'Change from baseline through study completion (9 months post-treatment)', 'description': 'Aberrant drug-related behaviors as evidenced by triangulated aggregate of Current Opioid Misuse Measure and/or clinician assessment via Addiction Behaviors Checklist and/or urine screen'}], 'secondaryOutcomes': [{'measure': 'Change in emotional distress', 'timeFrame': 'Change from baseline through study completion (9 months post-treatment)', 'description': 'Distress measured by the Depression, Anxiety, Stress Scale'}, {'measure': 'Change in opioid dose', 'timeFrame': 'Change from baseline through study completion (9 months post-treatment)', 'description': 'Opioid dose converted into morphine equivalents via standardized equianalgesic tables'}, {'measure': 'Change in opioid craving', 'timeFrame': 'Change from baseline through study completion (9 months post-treatment)', 'description': 'Craving measured by visual analogue scale'}, {'measure': 'Change in interoceptive awareness', 'timeFrame': 'Change from baseline through 8 weeks', 'description': 'Interoceptive awareness measured by the Multidimensional Assessment of Interoceptive Awareness'}, {'measure': 'Change in reappraisal', 'timeFrame': 'Change from baseline through 8 weeks', 'description': 'Reappraisal measured by the Emotion Regulation Questionnaire'}, {'measure': 'Change in savoring', 'timeFrame': 'Change from baseline through 8 weeks', 'description': 'Savoring measured by the brief Ways of Savoring checklist'}, {'measure': 'Change in meditative experiences', 'timeFrame': 'Change from baseline through 8 weeks', 'description': 'As measured by the Five Facet Mindfulness Questionnaire, self-salience and self-extension items, and/or Nondual Awareness Dimensional Assessment'}, {'measure': 'Change in body sensations', 'timeFrame': 'Change from baseline through 8 weeks', 'description': 'Change in pleasant, neutral, and unpleasant body sensations as measured by body map'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Pain']}, 'referencesModule': {'references': [{'pmid': '32915027', 'type': 'DERIVED', 'citation': 'Garland EL, Hudak J, Hanley AW, Nakamura Y. Mindfulness-oriented recovery enhancement reduces opioid dose in primary care by strengthening autonomic regulation during meditation. Am Psychol. 2020 Sep;75(6):840-852. doi: 10.1037/amp0000638.'}, {'pmid': '31556669', 'type': 'DERIVED', 'citation': 'Garland EL, Hanley AW, Riquino MR, Reese SE, Baker AK, Salas K, Yack BP, Bedford CE, Bryan MA, Atchley R, Nakamura Y, Froeliger B, Howard MO. Mindfulness-oriented recovery enhancement reduces opioid misuse risk via analgesic and positive psychological mechanisms: A randomized controlled trial. J Consult Clin Psychol. 2019 Oct;87(10):927-940. doi: 10.1037/ccp0000390.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine the effects of Mindfulness-Oriented Recovery Enhancement versus a social support group (supportive counseling) intervention for chronic pain patients receiving long-term opioid pharmacotherapy for pain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-60+\n* Current chronic pain condition\n* Current use of prescription opioid agonist or mixed agonist-antagonist analgesics for \\>90 days\n\nExclusion Criteria:\n\n* Prior experience with Mindfulness-Based Stress Reduction, Mindfulness-Based Cognitive Therapy, or Mindfulness-Based Relapse Prevention\n* Active suicidality, schizophrenia, psychotic disorder, and/or severe substance dependence (other than opioid dependence)\n* Opioid misuse as determined by Current Opioid Misuse Measure'}, 'identificationModule': {'nctId': 'NCT03298269', 'briefTitle': 'Behavioral Interventions for Chronic Pain and Opioid-Related Problems', 'organization': {'class': 'OTHER', 'fullName': 'University of Utah'}, 'officialTitle': 'Behavioral Interventions for Chronic Pain and Opioid-Related Problems', 'orgStudyIdInfo': {'id': '1618'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mindfulness-Oriented Recovery Enhancement', 'interventionNames': ['Behavioral: Mindfulness-Oriented Recovery Enhancement']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Supportive Counseling', 'interventionNames': ['Behavioral: Supportive Counseling']}], 'interventions': [{'name': 'Mindfulness-Oriented Recovery Enhancement', 'type': 'BEHAVIORAL', 'otherNames': ['MORE'], 'description': 'Mindfulness-Oriented Recovery Enhancement (MORE) is a group behavioral intervention led by a therapist that combines training in mindfulness, cognitive reappraisal, and savoring skills.', 'armGroupLabels': ['Mindfulness-Oriented Recovery Enhancement']}, {'name': 'Supportive Counseling', 'type': 'BEHAVIORAL', 'otherNames': ['Support Group'], 'description': 'A support group led by a therapist will allow participants to express emotions, share experiences, and receive social support.', 'armGroupLabels': ['Supportive Counseling']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84112', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'College of Social Work', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Utah', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Eric Garland', 'investigatorAffiliation': 'University of Utah'}}}}