Improving Treatment and Recovery Services for Individuals With Opioid Problems

• Conditions: Counseling
• Interventions: Behavioral: Recovery Guide Counseling

• Registration Number: NCT05129813
• Lead Sponsor: Howard University

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.

Detailed Description

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. Interviews use a semi-structured format assessing current and past opioid and other substance use, adherence to buprenorphine, and experiences with the counseling and other services provided.

Study Timeline

• Study Start: 2021-10-15
• Status Verified: 2021-11
• Study First Submitted: 2021-11-10
• Study First Submitted QC: 2021-11-19
• Last Update Submitted: 2021-11-19
• Study First Posted: 2021-11-22
• Last Update Posted: 2021-11-22
• Primary Completion: 2022-05-31
• Study Completion: 2022-05-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Opioid use disorder
• Initiating buprenorphine treatment

Exclusion Criteria

• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Buprenorphine MOUD in FQHC	Recovery Guide Counseling	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	Recovery Guide Counseling	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.

Primary Outcome Measures

Name	Time	Method
Treatment Retention	12 weeks	Proportion of participants continuing to receive buprenorphine treatment at 12 weeks

Secondary Outcome Measures

Name	Time	Method
Treatment satisfaction	12 weeks	Self-reported satisfaction with treatment
Medication adherence	12 weeks	Percent days self-reported medication adherence

Trial Locations

Locations (1)

Howard University; 🇺🇸 Washington, District of Columbia, United States