Opioid-use DisorderNCT04824404
CBT4CBT-Buprenorphine + Recovery Coach for Office-based Buprenorphine
A study testing CBT4CBT-Buprenorphine + Recovery Coach in people with Opioid-use Disorder, run by Prisma Health-Upstate at 1 site in United States.
Trial summary
To conduct an 8-week pilot, randomized trial evaluating the feasibility, acceptability, and efficacy of an integrated intervention involving CBT4CBT-Buprenorphine + Recovery Coach in a population of 60 individuals who meet current DSM criteria for opioid use disorder and are receiving buprenorphine treatment in… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Opioid-use Disorder
- What is being tested?
- CBT4CBT-Buprenorphine + Recovery Coach
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2020to 6 Dec 2022
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- adults (≥18 years)
- having a DSM-V diagnosis of OUD
- sublingual buprenorphine/naloxone and/or buprenorphine
- having initiated maintenance treatment for OUD for at least 30 days before the screening
- self-report or toxicology screening positive for any substance within 30 days of screening;
- willing to accept a random assignment to either TAU/CBT4CBT-Buprenorphine + Recovery Coach;
- having adequate computer skills
Who cannot join
- having a severe medical or psychiatric disability that could impair their ability to perform study-related activities (determined by the clinician)
- being pregnant or breastfeeding;
- being unable to independently read and/or comprehend the consent form or other study materials
- being unable to read/speak English;
- having current suicidal ideation based on the Patient Health Questionnaire-9.
Trial locations and contacts
1 site in 1 country.
United States1 site
Internal Medicine Recovery Clinic
Greenville, South Carolina, 29605
About this study
Official title: Integrated Intervention Combining CBT4CBT-Buprenorphine + Recovery Coach for Office-based Buprenorphine
To conduct an 8-week pilot, randomized trial evaluating the feasibility, acceptability, and efficacy of an integrated intervention involving CBT4CBT-Buprenorphine + Recovery Coach in a population of 60 individuals who meet current DSM criteria for opioid use disorder and are receiving buprenorphine treatment in primary care.
Read the detailed description
In this pilot study, 50 individuals with OUD on buprenorphine will be randomized to either 1) standard of care (N=25) or (2)CBT4CBT-Buprenorphine + Recovery Coach (N=250). This will be an 8-week trial.
- Conditions
- Opioid-use Disorder
- Being tested
- CBT4CBT-Buprenorphine + Recovery Coach
- 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.
CBT4CBT-Buprenorphine + Recovery CoachBehavioural
Also called CBT4CBT+ Recovery Coach
This condition will consist of the CBT4CBT-Buprenorphine intervention alongside weekly coaching sessions from a recovery professionalCBT4CBT-Buprenorphine is an 8-session (module) system for teaching a wide range of CBT skills (understanding and changing patterns of substance use; coping with craving; refusing offers of drugs and alcohol; problem-solving skills; identifying and changing thoughts about drugs and alcohol; and improving decision-making skills)
| Study group | Role | What they receive |
|---|---|---|
| Standard Treatment As Usual (TAU) | No intervention | Participants in the standard of care condition will receive the standard treatment at the recovery program, which consists of weekly or bi-weekly visits (at the discretion of the provider) to the clinic to meet with their provider and provide a sample of blood. |
| CBT4CBT-Buprenorphine + Recovery Coach | Experimental | This condition will consist of the CBT4CBT-Buprenorphine intervention alongside weekly coaching sessions from a recovery professional Receives: Behavioral: CBT4CBT-Buprenorphine + Recovery Coach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in drug use
Using saliva toxicology tests
Measured: 0-8 weeks
Secondary outcomes (2)
Retention to buprenorphine
enrollment in and receiving buprenorphine and/or other effective medication treatment for OUD which will be verified by either report from the treatment clinic or electronic medical record
Measured: 3 month follow up
Change in drug use
Using saliva toxicology tests
Measured: 1 and 3 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start15 Dec 2020
- Primary completion6 Dec 2022
- Study completion6 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid-use DisorderStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prisma Health-Upstate
- Sponsor type
- University, hospital or other
- Collaborators
- Clemson University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04824404
- Sponsor's protocol ID
- 87691
- Status last verified
- Oct 2024
- First submitted
- 19 Mar 2021
- Last updated
- 1 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 1 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Intervention Combining CBT4CBT-Buprenorphine + Recovery Coach for Office-based Buprenorphine
- ClinicalTrials.gov ID
- NCT04824404
- Acronym / sponsor ID
- 87691
- Conditions
- Opioid-use Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Prisma Health-UpstateUniversity, hospital or other
- Collaborators
- Clemson University
- Study start
- 15 Dec 2020 (actual)
- Primary completion
- 6 Dec 2022 (actual)
- Study completion
- 6 Dec 2022 (actual)
- First posted
- 1 Apr 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.
To conduct an 8-week pilot, randomized trial evaluating the feasibility, acceptability, and efficacy of an integrated intervention involving CBT4CBT-Buprenorphine + Recovery Coach in a population of 60 individuals who meet current DSM criteria for opioid use disorder and are receiving buprenorphine treatment in primary care.
Detailed description
In this pilot study, 50 individuals with OUD on buprenorphine will be randomized to either 1) standard of care (N=25) or (2)CBT4CBT-Buprenorphine + Recovery Coach (N=250). This will be an 8-week trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Treatment As Usual (TAU) | No intervention | –Participants in the standard of care condition will receive the standard treatment at the recovery program, which consists of weekly or bi-weekly visits (at the discretion of the provider) to the clinic to meet with their provider and provide a sample of blood. |
| CBT4CBT-Buprenorphine + Recovery Coach | Experimental | Behavioral: CBT4CBT-Buprenorphine + Recovery CoachThis condition will consist of the CBT4CBT-Buprenorphine intervention alongside weekly coaching sessions from a recovery professional |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- adults (≥18 years)
- having a DSM-V diagnosis of OUD
- sublingual buprenorphine/naloxone and/or buprenorphine
- having initiated maintenance treatment for OUD for at least 30 days before the screening
- self-report or toxicology screening positive for any substance within 30 days of screening;
Key exclusion criteria (5 listed)
- having a severe medical or psychiatric disability that could impair their ability to perform study-related activities (determined by the clinician)
- being pregnant or breastfeeding;
- being unable to independently read and/or comprehend the consent form or other study materials
- being unable to read/speak English;
- having current suicidal ideation based on the Patient Health Questionnaire-9.
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 |
|---|---|---|
| CBT4CBT-Buprenorphine + Recovery CoachAlso: CBT4CBT+ Recovery CoachThis condition will consist of the CBT4CBT-Buprenorphine intervention alongside weekly coaching sessions from a recovery professionalCBT4CBT-Buprenorphine is an 8-session (module) system for teaching a wide range of CBT skills (understanding and changing patterns of substance use; coping with craving; refusing offers of drugs and alcohol; problem-solving skills; identifying and changing thoughts about drugs and alcohol; and improving decision-making skills) | Behavioural | CBT4CBT-Buprenorphine + Recovery Coach |
Primary outcome
Change in drug use
Time frame: 0-8 weeks
Using saliva toxicology tests
2 secondary outcomes
Retention to buprenorphine
Time frame: 3 month follow up
Change in drug use
Time frame: 1 and 3 month follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2024.
- Individual participant dataSharing planned: No
Related trials for Opioid-use Disorder
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Enrolling by invitationObservational study
Development of an Interview-Informed Timeline Follow-Back (TLFB) for Opioid Use in the Era of Fentanyl
Substance Use Disorders (SUDs)
Not yet recruiting
Comprehensive Opioid Management and Breathing During Sleep
Sleep-Disordered Breathing, Chronic Opioid Use
Active, not recruitingPhase 2
Wellcome Leap Psilocybin for OUD
Opioid Use Disorder
Recruiting
Opioid and Pain Treatment in Indigenous Communities (OPTIC) Trial
Opioid Use Disorder, Opioid Misuse
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBT4CBT-Buprenorphine + Recovery Coach in people with Opioid-use Disorder, run by Prisma Health-Upstate 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 7 inclusion and 5 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: finished, as of the sponsor's last update on 1 Nov 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in drug use (time frame: 0-8 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 1 Nov 2024.