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Improving Treatment and Recovery Services for Individuals With Opioid Problems

NCT ID: NCT05129813

Last Updated: 2021-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-10-15

Study Completion Date

2022-05-31

Brief Summary

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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

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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.

Conditions

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Counseling

Keywords

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Opioid Use Disorder Behavioral Counseling Peer Recovery Specialist Buprenorphine

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Buprenorphine MOUD in FQHC

Participants receiving buprenorphine treatment and Recovery Guide counseling in a Federally Qualified Health Center. Recovery Guide counseling is provided weekly.

Recovery Guide Counseling

Intervention Type BEHAVIORAL

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.

Recovery Guide Counseling

Intervention Type BEHAVIORAL

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

Interventions

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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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

Boston University

OTHER

Sponsor Role collaborator

University of Maryland, College Park

OTHER

Sponsor Role collaborator

Yale University

OTHER

Sponsor Role collaborator

Unity Health Care, Inc.

INDUSTRY

Sponsor Role collaborator

Howard University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Richard Schottenfeld, M.D.

Role: PRINCIPAL_INVESTIGATOR

Howard University

Locations

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Howard University

Washington D.C., District of Columbia, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Richard Schottenfeld, M.D.

Role: CONTACT

Phone: 202-865-6615

Email: [email protected]

Denise Scott, Ph.D.

Role: CONTACT

Phone: 202-865-2294

Email: [email protected]

Facility Contacts

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Richard Schottenfeld, M.D.

Role: primary

Denise Scott, Ph.D.

Role: backup

Other Identifiers

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3UG1DA013034-20

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB-18-MED-38

Identifier Type: -

Identifier Source: org_study_id