Improving Treatment and Recovery Services for Individuals With Opioid Problems
2 other identifiers
observational
20
1 country
1
Brief Summary
Participants include persons receiving buprenorphine treatment and Recovery Guide counseling in a Federally Qualified Health Center or buprenorphine treatment by telemedicine and Recovery Guide counseling in a church or faith-based community organization. Participants are interviewed at the outset of treatment, after 4 to 6 weeks, and then at 10 to 12 weeks of treatment. The study is an observational study aimed at evaluating the experiences and response to treatment of participants.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Oct 2021
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 15, 2021
CompletedFirst Submitted
Initial submission to the registry
November 10, 2021
CompletedFirst Posted
Study publicly available on registry
November 22, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2022
CompletedNovember 22, 2021
November 1, 2021
8 months
November 10, 2021
November 19, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Treatment Retention
Proportion of participants continuing to receive buprenorphine treatment at 12 weeks
12 weeks
Secondary Outcomes (2)
Medication adherence
12 weeks
Treatment satisfaction
12 weeks
Other Outcomes (2)
Self-reported opioid and other drug use
12 weeks
Health-related quality of life
12 weeks
Study Arms (2)
Buprenorphine MOUD in FQHC
Participants receiving buprenorphine treatment and Recovery Guide counseling in a Federally Qualified Health Center. Recovery Guide counseling is provided weekly.
Telemedicine Provision of Buprenorphine MOUD in a community site
Participants receiving buprenorphine treatment provided by telemedicine from a hub clinic and Recovery Guide counseling in a church or faith-based community organization. Recovery Guide counseling is provided weekly.
Interventions
Recovery Guide Counseling is a 12-session psychoeducational and behavioral counseling intended for delivery by Peer Recovery Specialists, community health workers, or other personnel without advanced training in counseling
Eligibility Criteria
Potential participants will be recruited through posters, flyers, or word-of-mouth or information provided to them by neighborhood or community agencies or organizations or referred by their medical provider.
You may qualify if:
- Opioid use disorder
- Initiating buprenorphine treatment
You may not qualify if:
- Inability to understand the study protocol or assessment questions
- Severe medical or psychiatric co-morbidity, including active psychosis, high risk for suicide, or medical contraindications to buprenorphine (e.g., allergy or sensitivity to buprenorphine),
- Currently (or in the past 30 days) receiving MAT for OUD.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Howard Universitylead
- National Institute on Drug Abuse (NIDA)collaborator
- Boston Universitycollaborator
- University of Maryland, College Parkcollaborator
- Yale Universitycollaborator
- Unity Health Care, Inc.collaborator
Study Sites (1)
Howard University
Washington D.C., District of Columbia, 20060, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Richard Schottenfeld, M.D.
Howard University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 10, 2021
First Posted
November 22, 2021
Study Start
October 15, 2021
Primary Completion
May 31, 2022
Study Completion
May 31, 2022
Last Updated
November 22, 2021
Record last verified: 2021-11
Data Sharing
- IPD Sharing
- Will not share