230 Participants Needed

CBT4CBT-Buprenorphine for Opioid Use Disorder

(OUD Trial)

KB
AA
Overseen ByAmber Anderson, BA
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Medical University of South Carolina
Must be taking: Buprenorphine
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how social interactions affect treatment outcomes for individuals with opioid use disorder (OUD). It combines a digital therapy program, CBT4CBT-Buprenorphine, with buprenorphine, a medication that helps manage OUD, to assess their combined effectiveness. The trial seeks participants who have used buprenorphine for no more than four weeks and have a supportive significant other willing to join the study. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance treatment strategies for OUD.

Will I have to stop taking my current medications?

The trial requires that you continue taking buprenorphine as prescribed by your provider. The protocol does not specify if you need to stop other medications, so it's best to discuss this with the study team.

Is there any evidence suggesting that CBT4CBT-Buprenorphine is likely to be safe for humans?

Research has shown that CBT4CBT, a computer-based therapy, combined with buprenorphine is generally safe for people with opioid use disorder (OUD). Studies found that patients who tried this treatment reported high satisfaction, with scores averaging 4.9 out of 5, indicating a positive experience for most participants.

The treatment effectively reduced drug use and supported recovery. It also demonstrated good retention rates, meaning participants could maintain the treatment over time. This is important because it shows the treatment is not only helpful but also easy to continue.

Buprenorphine, a component of this treatment, has already received FDA approval for treating opioid use disorder, which adds confidence in its safety. Overall, these findings suggest that CBT4CBT with buprenorphine is a safe option worth considering for those seeking help with OUD.12345

Why are researchers excited about this trial?

Researchers are excited about CBT4CBT-Buprenorphine for opioid use disorder because it combines cognitive behavioral therapy (CBT) with buprenorphine treatment in a digital format. Unlike traditional treatments that typically involve medication or in-person therapy sessions, this approach offers an innovative way to deliver effective therapy through an online platform. This digital delivery can make treatment more accessible and convenient for patients, potentially improving adherence and outcomes. Additionally, integrating CBT with buprenorphine may enhance the overall effectiveness of the treatment by addressing both the psychological and physical aspects of opioid addiction simultaneously.

What evidence suggests that CBT4CBT-Buprenorphine might be an effective treatment for opioid use disorder?

Research has shown that combining Cognitive Behavioral Therapy (CBT) with buprenorphine can be very effective for people with opioid use disorder (OUD). For those primarily using prescription opioids, CBT helps maintain abstinence. This treatment increases the likelihood of avoiding opioids. Studies suggest that adding structured counseling to buprenorphine treatment enhances its effectiveness. Early results from trials with CBT4CBT-Buprenorphine, the treatment under study in this trial, have shown promising outcomes, with fewer drug-positive tests. Overall, this combined approach appears to be a strong option for improving recovery from opioid addiction.26789

Who Is on the Research Team?

AM

Amber M Jarnecke, PhD

Principal Investigator

Medical University of South Carolina

RT

Rachel Tomko, PhD

Principal Investigator

Medical University of South Carolina

Are You a Good Fit for This Trial?

This trial is for adults with opioid use disorder (OUD) where opioids are their primary substance of choice. Participants must have a concerned significant other willing to join the study, meet DSM-5 criteria for OUD, and be on buprenorphine treatment for no more than 4 weeks. Stable psychotropic medication users can also participate.

Inclusion Criteria

I am 18 years old or older, regardless of my sex, gender, race, or ethnicity.
Patient participants must meet DSM-5 diagnostic criteria for current Opioid Use Disorder (OUD) assessed via the Quick Structured Clinical Interview for DSM-5 (Quick SCID)
Concurrent substance use disorders (e.g., alcohol, cannabis) are acceptable, provided opioids are the patient participant's primary substance of choice
See 2 more

Exclusion Criteria

Prisoners, institutional individuals, and children will not be recruited for this study
Moderate-to-severe opioid withdrawal as defined by a score of ≥21 on the Subjective Opioid Withdrawal Scale
Severe interpersonal violence in the past six months between the patient and the CSO, as defined by an adapted version of the Conflict Tactics Scaled Revised (CTS-2)
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive CBT4CBT-Buprenorphine treatment and are monitored for social functioning and OUD treatment outcomes

14 weeks
Weekly assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • CBT4CBT-Buprenorphine

Trial Overview

The study tests how improving social functioning affects OUD treatment outcomes using CBT4CBT-Buprenorphine—a combination therapy involving cognitive-behavioral strategies and medication. It includes patients with OUD and their significant others to identify modifiable social factors that influence recovery.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: CBT4CBT-BuprenorphineExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials
994
Recruited
7,408,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials
2,658
Recruited
3,409,000+

National Institutes of Health (NIH)

Collaborator

Trials
2,896
Recruited
8,053,000+

Citations

Behavioral Therapy as an Adjunct to Buprenorphine ... - PMC

These findings suggest that buprenorphine plus high-quality, low-intensity medical counseling is highly effective for opioid use disorder.

Cognitive Behavioral Therapy Improves Treatment ...

CBT improved abstinence for all drugs of abuse for prescription opioid use patients. · CBT did not lead to better outcomes for heroin use patients. · Further ...

Cognitive Behavioral Therapy Improves Treatment Outcomes ...

Findings indicated that for patients with primary prescription opioid use, PM with CBT led to better abstinence outcomes for all drugs of abuse ...

CBT4CBT-Buprenorphine + Recovery Coach for Office- ...

To conduct an 8-week pilot, randomized trial evaluating the feasibility, acceptability, and efficacy of an integrated intervention involving CBT4CBT- ...

A Randomized Pilot Trial of an Integrated Intervention

The integrated intervention—CBT4CBT-Bupre- norphine and peer recovery coaching—showed prelim- inary effectiveness in reducing drug-positive saliva samples ...

Three-month outcomes from a patient-centered program to ...

This study shows that people with OUD can achieve a high treatment retention rate, cut down their use of illicit drugs, and build their recovery capital. More ...

Behavioral Therapy and Buprenorphine Treatment for ...

Main Outcomes and Measures The main outcomes included weeks of buprenorphine retention and functioning across 7 domains (medical, employment and ...

Rationale, design, and methodology of a randomized pilot ...

This trial will provide evidence of the efficacy of an integrated intervention combining CBT4CBT and Recovery Coaching for reducing substance use and increasing ...

A Randomized Pilot Trial of an Integrated Intervention ...

Satisfaction with the intervention, coach, and CBT4CBT-buprenorphine was high (M≥4.9). Drug use was significantly lower in the CBT4CBT+RC group ...