CClinicalTrials.gg
Status unknownNCT05129813Updated Nov 22, 2021

Improving Treatment and Recovery Services for Individuals With Opioid Problems

An observational study in Counseling, sponsored by Howard University. Status unknown at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-11-22.

Sponsored by Howard University · Observational

The sponsor has not verified this record recently (last verified Nov 2021), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
20
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Counseling

Keywords

  • Opioid Use Disorder
  • Behavioral Counseling
  • Peer Recovery Specialist
  • Buprenorphine
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In context

Lead sponsor

Howard University is the lead sponsor of 16 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

Inclusion criteria

  • Opioid use disorder
  • Initiating buprenorphine treatment

Exclusion criteria

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.
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
20 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • 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

Interventions

  • BehavioralRecovery 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

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What researchers measure

Primary outcomes

  1. Treatment Retention

    Proportion of participants continuing to receive buprenorphine treatment at 12 weeks

    Time frame: 12 weeks

Secondary outcomes

  1. Medication adherence

    Percent days self-reported medication adherence

    Time frame: 12 weeks

  2. Treatment satisfaction

    Self-reported satisfaction with treatment

    Time frame: 12 weeks

Other outcomes

  1. Self-reported opioid and other drug use

    Self-reported drug use

    Time frame: 12 weeks

  2. Health-related quality of life

    Self-reported health-related quality of life

    Time frame: 12 weeks

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Study locations

1 of 1 sites recruiting
  • Howard University
    Washington, District of Columbia 20060, United States
    Recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 22, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05129813
Lead sponsor
Howard University
Collaborators
National Institute on Drug Abuse (NIDA), Boston University, University of Maryland, College Park, Yale University, Unity Health Care, Inc.
Responsible party
Sponsor
First posted
Nov 22, 2021
Start date
Oct 15, 2021
Primary completion
May 31, 2022 (estimated)
Completion
May 31, 2022 (estimated)
Last update
Nov 22, 2021

Study contacts

Richard Schottenfeld, M.D.
Contact
richard.schottenfeld@howard.edu
202-865-6615
Denise Scott, Ph.D.
Contact
d_m_scott@howard.edu
202-865-2294
Richard Schottenfeld, M.D.
principal investigator · Howard University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.

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