CounselingNCT05129813
Improving Treatment and Recovery Services for Individuals With Opioid Problems
An observational study of Counseling, run by Howard University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Counseling
- What is being tested?
- Recovery Guide Counseling
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2021to 31 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Opioid use disorder
- Initiating buprenorphine treatment
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Howard University
Washington D.C., District of Columbia, 20060
Richard Schottenfeld, M.D., 202-865-6615, richard.schottenfeld@howard.edu
Denise Scott, Ph.D., 202-865-2294, d_m_scott@howard.edu
About this study
Official title: 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.
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.
- Conditions
- Counseling
- Being tested
- Recovery Guide Counseling
- Keywords
- Opioid Use Disorder, Behavioral Counseling, Peer Recovery Specialist, Buprenorphine
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recovery Guide CounselingBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Buprenorphine MOUD in FQHC | Participants receiving buprenorphine treatment and Recovery Guide counseling in a Federally Qualified Health Center. Recovery Guide counseling is provided weekly. Receives: 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. Receives: Behavioral: Recovery Guide Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Retention
Proportion of participants continuing to receive buprenorphine treatment at 12 weeks
Measured: 12 weeks
Secondary outcomes (2)
Medication adherence
Percent days self-reported medication adherence
Measured: 12 weeks
Treatment satisfaction
Self-reported satisfaction with treatment
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2021
- Study start15 Oct 2021
- Primary completion31 May 2022 (estimated)
- Study completion31 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CounselingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Howard University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), Boston University, University of Maryland, College Park, Yale University, Unity Health Care, Inc.
- Responsible party
- Sponsor
- Investigators
- Richard Schottenfeld, M.D., Principal investigator, Howard University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05129813
- Sponsor's protocol ID
- IRB-18-MED-38
- Other IDs
- 3UG1DA013034-20
- Status last verified
- Nov 2021
- First submitted
- 10 Nov 2021
- Last updated
- 22 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Treatment and Recovery Services for Individuals With Opioid Problems and Their Family Members
- ClinicalTrials.gov ID
- NCT05129813
- Acronym / sponsor ID
- IRB-18-MED-38
- Conditions
- Counseling
- Keywords
- Opioid Use Disorder, Behavioral Counseling, Peer Recovery Specialist, Buprenorphine
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Howard UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), Boston University, University of Maryland, College Park, Yale University, Unity Health Care, Inc.
- Study start
- 15 Oct 2021 (actual)
- Primary completion
- 31 May 2022 (estimated)
- Study completion
- 31 May 2022 (estimated)
- First posted
- 22 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Buprenorphine MOUD in FQHC | – | Behavioral: Recovery Guide CounselingParticipants receiving buprenorphine treatment and Recovery Guide counseling in a Federally Qualified Health Center. Recovery Guide counseling is provided weekly. |
| Telemedicine Provision of Buprenorphine MOUD in a community site | – | Behavioral: Recovery Guide CounselingParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Opioid use disorder
- Initiating buprenorphine treatment
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recovery Guide CounselingRecovery 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 | Behavioural | Buprenorphine MOUD in FQHC, Telemedicine Provision of Buprenorphine MOUD in a community site |
Primary outcome
Treatment Retention
Time frame: 12 weeks
Proportion of participants continuing to receive buprenorphine treatment at 12 weeks
2 secondary outcomes
Medication adherence
Time frame: 12 weeks
Treatment satisfaction
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Schottenfeld, M.D. principal investigator
Howard University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Counseling, run by Howard University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Richard Schottenfeld, M.D. (202-865-6615, richard.schottenfeld@howard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Retention (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2021.