Improving Treatment and Recovery Services for Individuals With Opioid Problems

Improving Treatment and Recovery Services for Individuals With Opioid Problems and Their Family Members

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.

Study Overview

• Status: Recruiting
• Conditions: Counseling
• Intervention / Treatment: Behavioral: Recovery Guide Counseling

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 Type: Observational
• Enrollment (Anticipated): 20

Contacts and Locations

• Study Contact: Name: Richard Schottenfeld, M.D.; Phone Number: 202-865-6615; Email: richard.schottenfeld@howard.edu
• Study Contact Backup: Name: Denise Scott, Ph.D.; Phone Number: 202-865-2294; Email: d_m_scott@howard.edu

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20060
      • Recruiting
      • Howard University
      • Contact: Richard Schottenfeld, M.D.; Phone Number: 202-865-6615; Email: richard.schottenfeld@howard.edu
      • Contact: Denise Scott, Ph.D.; Phone Number: 202-865-2294; Email: d_m_scott@howard.edu
      • Sub-Investigator: Gloria Cain, Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Buprenorphine MOUD in FQHC; Participants receiving buprenorphine treatment and Recovery Guide counseling in a Federally Qualified Health Center. Recovery Guide counseling is provided weekly.	Behavioral: Recovery Guide Counseling; 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
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.	Behavioral: Recovery Guide Counseling; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment Retention	Proportion of participants continuing to receive buprenorphine treatment at 12 weeks	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medication adherence	Percent days self-reported medication adherence	12 weeks
Treatment satisfaction	Self-reported satisfaction with treatment	12 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-reported opioid and other drug use	Self-reported drug use	12 weeks
Health-related quality of life	Self-reported health-related quality of life	12 weeks

Collaborators and Investigators

• Sponsor: Howard University
• Collaborators: Boston University; National Institute on Drug Abuse (NIDA); Yale University; University of Maryland, College Park; Unity Health Care, Inc.
• Investigators: Principal Investigator: Richard Schottenfeld, M.D., Howard University

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2021
• Primary Completion (Anticipated): May 31, 2022
• Study Completion (Anticipated): May 31, 2022

Study Registration Dates

• First Submitted: November 10, 2021
• First Submitted That Met QC Criteria: November 19, 2021
• First Posted (Actual): November 22, 2021

Study Record Updates

• Last Update Posted (Actual): November 22, 2021
• Last Update Submitted That Met QC Criteria: November 19, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Opioid Use Disorder; Buprenorphine; Behavioral Counseling; Peer Recovery Specialist
• Other Study ID Numbers: IRB-18-MED-38; 3UG1DA013034-20 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No