Ignite Creation Date:
2025-12-25 @ 1:41 AM
Ignite Modification Date:
2026-03-08 @ 11:03 PM
Study NCT ID:
NCT05700994
Status:
RECRUITING
Last Update Posted:
2025-07-10
First Post:
2023-01-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Peer Engagement in Methamphetamine Harm-Reduction With Contingency Management (PEER-CM)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'This is a cluster-randomized pragmatic trial using a hybrid type 1 effectiveness-implementation framework and stepped-wedge design.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1800}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-11-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-08', 'studyFirstSubmitDate': '2023-01-17', 'studyFirstSubmitQcDate': '2023-01-17', 'lastUpdatePostDateStruct': {'date': '2025-07-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants who overdose', 'timeFrame': '6 months from baseline', 'description': 'Test the impact of incentives for achieving self-identified, personal harm reduction goals on the likelihood of overdose among people using methamphetamine at 6 months from enrollment identified through completed assessment.'}, {'measure': 'Number of participants who achieve self-identified goals', 'timeFrame': '6 months from baseline', 'description': 'Determine whether incentives for achieving self-identified, personal harm reduction goals increases engagement with harm reduction services at 6 months from enrollment identified through completed assessment.'}, {'measure': 'Number of participants who engage in substance use disorder treatment', 'timeFrame': '6 months from baseline', 'description': 'Determine whether incentives for achieving self-identified, personal harm reduction goals increases engagement with treatment services at 6 months from enrollment identified through completed assessment.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Methamphetamine Abuse']}, 'referencesModule': {'references': [{'pmid': '40495203', 'type': 'DERIVED', 'citation': 'Cooke A, Stack E, Peng L, Cook R, Hartzler B, Leichtling G, Hildebran C, Leahy JM, Payne KS, Kunkel LE, Hoffman K, Korthuis PT. The peers expanding engagement in stimulant harm reduction with contingency management study: a protocol paper. Addict Sci Clin Pract. 2025 Jun 10;20(1):48. doi: 10.1186/s13722-025-00577-8.'}, {'pmid': '40329274', 'type': 'DERIVED', 'citation': 'Peng L, Stack E, Cooke A, Hartzler B, Cook R, Leichtling G, Hildebran C, Leahy J, Payne KS, Kunkel L, Hoffman K, Korthuis PT. Centering peers in design and training for a peer-delivered contingency management program for self-identified harm reduction and treatment goals. Harm Reduct J. 2025 May 6;22(Suppl 1):72. doi: 10.1186/s12954-025-01213-z.'}]}, 'descriptionModule': {'briefSummary': 'The main goal of this study is to tests the effect of incentivizing achievement of self-identified, personal harm reduction goals (Contingency management or CM) compared with standard of care (peer harm reduction service with incentives for peer visits) to increase the reach and effectiveness of methamphetamine (MA) harm reduction services.', 'detailedDescription': 'Using a hybrid type 1 effectiveness-implementation framework and stepped-wedge design, this study will randomize eighteen community-based peer harm reduction sites to provide contingency management incentives for achieving self-identified harm reduction goals set with peer specialists using a participant-driven harm reduction goal-setting process (e.g. completing overdose prevention and supply training, daily life goals, treatment and care goals, relationship and social support goals) versus standard of care contingency management (i.e. incentives for peer encounter attendance).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '105 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nThis intervention is at the site level. Community-based organization sites are eligible if they:\n\n* Use peer support specialists to provide direct outreach and harm reduction services to people who use drugs\n* Are willing to be trained in the two strategies for peer-facilitated contingency management\n\nClients who:\n\n* Age 18 and older\n* Any stimulant (methamphetamine, cocaine) use in the past 30 days\n* Willing to accept peer services\n* Willing to complete initial and follow-up assessments with peer\n* Able to communicate in English or Spanish\n\nExclusion Criteria:\n\nCommunity-based organization sites who:\n\n* Do not use peer support specialists to provide direct outreach and harm reduction services to people who use drugs\n* Are not willing to be trained in the two strategies for peer-facilitated contingency management\n\nClients who:\n\n• Present any danger or threat of violence to peers'}, 'identificationModule': {'nctId': 'NCT05700994', 'briefTitle': 'Peer Engagement in Methamphetamine Harm-Reduction With Contingency Management (PEER-CM)', 'organization': {'class': 'OTHER', 'fullName': 'Oregon Health and Science University'}, 'officialTitle': 'Peer Engagement in Methamphetamine Harm-Reduction With Contingency Management (PEER-CM)', 'orgStudyIdInfo': {'id': 'PEER-CM'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PEER-CM', 'description': 'Peer-facilitated contingency management (PEER-CM).', 'interventionNames': ['Behavioral: Peer Contingency Management']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard of Care', 'description': 'Standard of care contingency management.', 'interventionNames': ['Behavioral: Standard of Care Contingency Management']}], 'interventions': [{'name': 'Peer Contingency Management', 'type': 'BEHAVIORAL', 'otherNames': ['PEER-CM'], 'description': 'Participants allocated to peer-facilitated contingency management will receive incentives for achieving self-identified harm reduction goals set with peer specialists using a participant-driven harm reduction goal-setting process (e.g. completing overdose prevention and supply training, daily life goals, treatment and care goals, relationship and social support goals)', 'armGroupLabels': ['PEER-CM']}, {'name': 'Standard of Care Contingency Management', 'type': 'BEHAVIORAL', 'otherNames': ['Standard of Care'], 'description': 'Participants allocated to standard of care contingency management will receive incentives for peer encounters.', 'armGroupLabels': ['Standard of Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97232', 'city': 'Portland', 'state': 'Oregon', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Erin Stack', 'role': 'CONTACT', 'email': 'estack@comagine.org'}], 'facility': 'Comagine Health', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Todd Korthuis', 'role': 'CONTACT', 'email': 'korthuis@ohsu.edu'}], 'facility': 'Oregon Health & Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}], 'centralContacts': [{'name': 'Todd Korthuis, MD, MPH', 'role': 'CONTACT', 'email': 'korthuis@ohsu.edu', 'phone': '503494-8044'}, {'name': 'Sara McCrimmon, MPH', 'role': 'CONTACT', 'email': 'mccrimmo@ohsu.edu'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oregon Health and Science University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Comagine Health', 'class': 'OTHER'}, {'name': 'Oregon Health Authority', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'P. Todd Korthuis, MD', 'investigatorAffiliation': 'Oregon Health and Science University'}}}}