Clinical trial NCT05129813: Improving Treatment and Recovery Services for Individuals With Opioid Problems
Official title: Improving Treatment and Recovery Services for Individuals With Opioid Problems and Their Family Members
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Counseling
Keywords: Opioid Use Disorder
Behavioral Counseling
Peer Recovery Specialist
Buprenorphine
Lead sponsor: Howard University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: Boston University
name: University of Maryland, College Park
name: Yale University
name: Unity Health Care, Inc.
First posted: 2021-11-22
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Treatment Retention
timeFrame: 12 weeks
Secondary outcomes:
measure: Medication adherence
timeFrame: 12 weeks
measure: Treatment satisfaction
timeFrame: 12 weeks
Other outcomes:
measure: Self-reported opioid and other drug use
timeFrame: 12 weeks
measure: Health-related quality of life
timeFrame: 12 weeks
Locations:
city: Washington
country: United States
facility: Howard University
state: District of Columbia
Study officials:
affiliation: Howard University
name: Richard Schottenfeld, M.D.
role: PRINCIPAL_INVESTIGATOR
References: