Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2025-12-25 @ 9:44 PM
Study NCT ID:
NCT05288751
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-08
First Post:
2022-03-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Contingency Management for Opioid and Stimulant Use Disorders in Primary Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009293', 'term': 'Opioid-Related Disorders'}], 'ancestors': [{'id': 'D000079524', 'term': 'Narcotic-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-06-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-04', 'studyFirstSubmitDate': '2022-03-10', 'studyFirstSubmitQcDate': '2022-03-10', 'lastUpdatePostDateStruct': {'date': '2025-09-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-03-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Preliminary efficacy of CM on clinical outcomes: Visit Frequency', 'timeFrame': '30 days post-intervention', 'description': 'Number of completed clinical visits per patient during the CM program.'}, {'measure': 'Preliminary efficacy of CM on clinical outcomes: Urine toxicology', 'timeFrame': '30 days post-intervention', 'description': 'Percentage of UDS results that are negative for stimulants during the CM intervention period.'}, {'measure': 'Feasibility of CM for OUD in primary care: Recruitment', 'timeFrame': '30 days post-intervention', 'description': 'percentage of patients invited to participate enroll in the treatment intervention.'}, {'measure': 'Feasibility of CM for OUD in primary care: Retention', 'timeFrame': '30 days post-intervention', 'description': 'Of those patients who enroll in the intervention study, the percent that complete the CM intervention period.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['opioid use disorder', 'stimulant use disorder', 'contingency management', 'primary care', 'addiction medicine', 'buprenorphine'], 'conditions': ['Opioid Use Disorder', 'Stimulant Use Disorder']}, 'descriptionModule': {'briefSummary': 'Contingency management (CM) is a behavioral intervention that involves incentivizing participants for target behaviors in a clinical setting. When applied to the treatment of substance use disorders, it has demonstrated efficacy in reducing the number of urine toxicology screens positive for illicit substances and increased engagement in treatment programs. However, there is a need to translate CM treatment to primary care settings. This study will implement and assess a CM program for patients with opioid use disorder, with or without comorbid stimulant use disorder, initiating outpatient addiction medicine services at a family medicine residency clinic. Eligible patients will earn monetary incentives for attending addiction medicine appointments and abstaining from substances during outpatient treatment. Data gathered from this pilot program will be used to improve patient outcomes, treatment, and retention for persons receiving medications for opioid use disorder (MOUDs) in a primary care setting.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At least 18 years of age\n* Diagnosis of Opioid Use Disorder and/or Stimulant Use Disorder\n* Recently initiated medications for opioid use disorder (MOUDs) at Broadway Family Medicine (BFM), within 2 weeks of recruitment\n* Have an active prescription for buprenorphine-naloxone (Suboxone)\n\nExclusion Criteria:\n\n* Prescription for an amphetamine would exclude patients from the abstinence-based CM, but they could participate in the attendance-only CM.\n* Dementia, development disabilities, or cognitive functioning that is too low to participate in study measures, as determined by chart review and consultation with overseeing physician.'}, 'identificationModule': {'nctId': 'NCT05288751', 'briefTitle': 'Contingency Management for Opioid and Stimulant Use Disorders in Primary Care', 'organization': {'class': 'OTHER', 'fullName': 'University of Minnesota'}, 'officialTitle': 'Contingency Management as a Treatment for Opioid Use Disorder and Stimulant Use Disorder in a Primary Care Setting', 'orgStudyIdInfo': {'id': 'FMCH-2022-30581'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Treatment as usual (TAU)', 'description': 'These patients will not be assigned to the CM programs, but will be invited to complete study measures at the same time points: baseline, 3-months, 6-months, and 12-months.'}, {'type': 'EXPERIMENTAL', 'label': 'Attendance-only CM', 'description': "Patients in this arm complete an appointments with his or her primary care provider (PCP) or member of the PCP's microteam . These appointments must be initiated by the PCP/microteam in accordance with the patient's treatment plan for regular follow-up appointments.", 'interventionNames': ['Behavioral: Contingency Management']}, {'type': 'EXPERIMENTAL', 'label': 'Attendance + abstinence CM', 'description': 'Patients who test stimulant-positive during the initial urine drug screen (UDS) at their intake visit will be invited to additionally enroll in the abstinence CM schedule. All of the attendance-only CM rules described previously will apply to patients in the attendance + abstinence program.', 'interventionNames': ['Behavioral: Contingency Management']}], 'interventions': [{'name': 'Contingency Management', 'type': 'BEHAVIORAL', 'description': 'Contingency management (CM) is a behavioral intervention that involves incentivizing participants for target behaviors in a clinical setting.', 'armGroupLabels': ['Attendance + abstinence CM', 'Attendance-only CM']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'University of Minnesota', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}], 'overallOfficials': [{'name': 'Robert Levy, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Minnesota'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Minnesota', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}