Ignite Creation Date:
2025-12-24 @ 10:08 PM
Ignite Modification Date:
2026-02-22 @ 4:13 AM
Study NCT ID:
NCT02902835
Status:
TERMINATED
Last Update Posted:
2018-09-13
First Post:
2016-08-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BUPrenorphine Facilitated Access and Supportive Treatment --AIM 3
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': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'whyStopped': 'Grant Funding Ended', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2018-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-11', 'studyFirstSubmitDate': '2016-08-12', 'studyFirstSubmitQcDate': '2016-09-12', 'lastUpdatePostDateStruct': {'date': '2018-09-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Initiation of buprenorphine treatment', 'timeFrame': 'At 180 days post enrollment', 'description': "Initiation of buprenorphine treatment within 180 days of study enrollment will be confirmed by reviewing the patient's medical records. Participants will sign a release for protected health information in order to confirm buprenorphine induction and visits. Initiation of buprenorphine treatment will be defined as receiving one or more prescription for buprenorphine or buprenorphine-naloxone."}], 'secondaryOutcomes': [{'measure': 'Opioid use (self-reported)', 'timeFrame': 'At 45 days post enrollment', 'description': 'Participants will complete interviews (adapted Addiction Severity Index) at study enrollment and at 45 days follow-up, self-reporting opioid use (heroin, opioid analgesics, methadone, illicit buprenorphine).'}, {'measure': 'Opioid use (urine drug testing)', 'timeFrame': 'At 45 days post enrollment', 'description': 'Participants will complete urine drug testing at study enrollment and at 45 days follow-up, assessing for any opioid use (opiates, oxycodone, methadone, buprenorphine).'}, {'measure': 'Criminal activity', 'timeFrame': 'At 45 days post enrollment', 'description': 'Participants will complete interviews (Addiction Severity Index) at study enrollment and 45 days follow-up, self-reporting involvement in criminal activities in the previous 30 days (# days with involvement).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Buprenorphine treatment', 'Incarceration', 'Linkage Intervention', 'Opioid use disorder'], 'conditions': ['Opioid-related Disorders']}, 'descriptionModule': {'briefSummary': 'The goal of this study is to test whether peer mentors (i.e., individuals with past opioid addiction and prior incarceration) can facilitate entrance into buprenorphine (Suboxone) treatment for individuals with opioid use disorder who were recently released from jail or prison. In order to test whether it is helpful to have peer mentors paired with recently released individuals, the investigators will conduct an 18 month study, recruiting 72 formerly incarcerated individuals and assigning them by chance selection (like flipping a coin) to either a group that will receive peer mentorship or a group that will receive a referral to a community clinic.', 'detailedDescription': 'BUPrenorphine Facilitated Access and Supportive Treatment (BUP-FAST) is a peer mentorship intervention in which trained peer mentors will link formerly incarcerated individuals with opioid use disorder to addiction treatment (i.e. buprenorphine maintenance treatment) following release from incarceration. The current study is a pilot randomized control trial evaluating the effectiveness and feasibility of the peer mentorship intervention.\n\nThe investigators are conducting this study due to the high rates of relapse to opioid use following release from prison (up to 75% within 3 months) and difficulty that some formerly incarcerated individuals report in accessing effective treatments for opioid use disorder. The investigators hypothesize that having peer mentors - who themselves have experienced incarceration and have had success with buprenorphine treatment for opioid use disorder - assisting formerly incarcerated individuals in seeking treatment will result in higher rates of linkage to care in comparison to referral to a community health center for buprenorphine treatment.\n\nIn this 18-month randomized control trial of the BUP-FAST intervention, the investigators will recruit 72 formerly incarcerated individuals with opioid use disorder; half will then be randomized to receive the BUP-FAST intervention (peer mentorship); and the other half (control) will receive referral to a community health center for assessment for buprenorphine treatment. Medication will not be provided as part of this study. Participants will only receive buprenorphine treatment if they meet appropriate medical criteria after assessment at the community health center.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Current or prior (at the time of incarceration) opioid use disorder by DSM-V criteria\n2. ≥ 18 years old\n3. Fluent in English or Spanish\n4. Released from incarceration in the last 4 weeks\n\nExclusion Criteria:\n\n1. Current buprenorphine or methadone maintenance treatment\n2. Pregnancy'}, 'identificationModule': {'nctId': 'NCT02902835', 'acronym': 'BUPFAST', 'briefTitle': 'BUPrenorphine Facilitated Access and Supportive Treatment --AIM 3', 'organization': {'class': 'OTHER', 'fullName': 'Montefiore Medical Center'}, 'officialTitle': 'BUPrenorphine Facilitated Access and Supportive Treatment--AIM 3', 'orgStudyIdInfo': {'id': '2016-6559'}, 'secondaryIdInfos': [{'id': 'K23DA034541', 'link': 'https://reporter.nih.gov/quickSearch/K23DA034541', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Referral to treatment (Control)', 'description': 'The control group will receive a referral to buprenorphine treatment by the research staff.', 'interventionNames': ['Behavioral: Referral to treatment']}, {'type': 'EXPERIMENTAL', 'label': 'BUP-FAST Intervention', 'description': 'Thirty-six participants will each be paired with a trained peer mentor who will provide the BUP-FAST intervention.', 'interventionNames': ['Behavioral: BUP_FAST']}], 'interventions': [{'name': 'BUP_FAST', 'type': 'BEHAVIORAL', 'description': 'Peer mentorship including: buprenorphine education, identifying buprenorphine providers, accompaniment at appointments, and psychosocial support (via outreach phone calls)', 'armGroupLabels': ['BUP-FAST Intervention']}, {'name': 'Referral to treatment', 'type': 'BEHAVIORAL', 'description': 'Participants will receive a pamphlet describing the buprenorphine treatment program at a Montefiore community health center.', 'armGroupLabels': ['Referral to treatment (Control)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10467', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Montefiore Medical Center', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Montefiore Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Medicine', 'investigatorFullName': 'Aaron D. Fox', 'investigatorAffiliation': 'Montefiore Medical Center'}}}}