Improving Treatment and Recovery Services for Individuals With Opioid Problems

Counseling Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05129813
• Other study ID #: IRB-18-MED-38
• Secondary ID: 3UG1DA013034-20
• Status: Recruiting
• Start date: October 15, 2021
• Est. completion date: May 31, 2022

Study information

• Verified date: November 2021
• Source: Howard University
• Contact: Richard Schottenfeld, M.D.
• Phone: 202-865-6615
• Email: richard.schottenfeld[@]howard.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: May 31, 2022
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Counseling

Intervention

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

Locations

Country	Name	City	State
United States	Howard University	Washington	District of Columbia

Sponsors (6)

Lead Sponsor	Collaborator
Howard University	Boston University, National Institute on Drug Abuse (NIDA), Unity Health Care, Inc., University of Maryland, College Park, Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Self-reported opioid and other drug use	Self-reported drug use	12 weeks
Other	Health-related quality of life	Self-reported health-related quality of life	12 weeks
Primary	Treatment Retention	Proportion of participants continuing to receive buprenorphine treatment at 12 weeks	12 weeks
Secondary	Medication adherence	Percent days self-reported medication adherence	12 weeks
Secondary	Treatment satisfaction	Self-reported satisfaction with treatment	12 weeks