Therapy and Peer Support for Opioid Use Disorder

Overseen By Brook Burkley, MSW

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Public Health Management Corporation

Must be taking: Buprenorphine

Disqualifiers: Intoxicated, Cognitively impaired, Unstable, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the best ways to combine medication with psychosocial support for people with opioid use disorder (OUD). It tests various treatment combinations, including standard medication with buprenorphine, alongside options like cognitive behavioral therapy (CBT) and peer support. The goal is to determine which mix works best for different patient types to enhance their recovery journey. Individuals who have struggled with opioid use and are eligible for buprenorphine treatment might find this trial suitable. As an unphased trial, this study provides a unique opportunity to contribute to innovative approaches in OUD treatment.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It focuses on adding psychosocial support to existing buprenorphine treatment for opioid use disorder.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that combining cognitive behavioral therapy (CBT) and peer support with medication-assisted treatment (MAT) is safe for patients with opioid use disorder (OUD). Studies have found that these therapies can be added to MAT, which includes buprenorphine, a medication used to treat OUD, without causing serious side effects.

In past research, using CBT and peer support alongside MAT did not lead to major problems. Patients generally found these therapies helpful and easy to manage. These methods have been tested in various settings, proving they can be safely included in regular OUD care.

Overall, evidence suggests that adding CBT and peer support to MAT is a safe choice for people with OUD. This should reassure those considering trials involving these treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for opioid use disorder because they integrate psychosocial support with medication-assisted treatment (MAT) in innovative ways. Unlike standard care that focuses solely on buprenorphine, these approaches combine MAT with cognitive-behavioral therapy (CBT) and Certified Recovery Specialist (CRS) peer support. This combination aims to address not just the physical aspects of addiction but also the psychological and social challenges. By offering a more holistic approach, these treatments have the potential to improve recovery rates and provide more comprehensive support for individuals battling opioid addiction.

What evidence suggests that this trial's psychosocial treatments could be effective for opioid use disorder?

This trial will compare different approaches to treating opioid use disorder (OUD). Studies have shown that adding cognitive behavioral therapy (CBT) to medication-assisted treatment (MAT) can help people stay in treatment programs longer. In this trial, some participants will receive MAT with CBT, which addresses the mental and emotional aspects of addiction, enhancing MAT's effectiveness. Other participants will receive MAT with peer support, such as working with a certified recovery specialist (CRS). Research shows that peer support helps people stay engaged in treatment and supports their recovery. It has been linked to better participation in therapy and can lower the risk of opioid-related death by up to 50%. Additionally, some participants will receive both CBT and peer support along with MAT, offering a more comprehensive approach that may lead to better outcomes for people with OUD. ^{2 6 7 8 9}

Who Is on the Research Team?

David S Festinger, Ph.D.

Principal Investigator

Philadelphia College of Osteopathic Medicine

Are You a Good Fit for This Trial?

This trial is for individuals with Opioid Use Disorder who are currently on medication-assisted treatment. It's designed to explore the benefits of adding psychosocial support to their regimen. Participants should be interested in how different psychological treatments can complement their current therapy.

Inclusion Criteria

Permit the research team to use and disclose their protected health information (PHI)

I am approved for buprenorphine treatment for opioid use disorder and agree to follow it.

I do not need hospitalization for my care.

Exclusion Criteria

Patients with SUD primarily for a different substance will be excluded

Individuals who are intoxicated, cognitively impaired, or psychiatrically unstable at baseline will not be included; however, they may subsequently be included if the disqualifying condition subsides

I do not have severe psychiatric needs.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive office-based buprenorphine treatment with either standard Medication Management, CBT, CRS, or both CBT and CRS

12 months

Weekly visits until stable, then monthly

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Assessments at 3, 6, 9, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Psychosocial treatment

Trial Overview The study is testing various forms of psychosocial treatment as a component of medication-assisted therapy for opioid addiction. The aim is to find out which approaches work best for different patients, moving away from generic treatments and towards more personalized care.

How Is the Trial Designed?

Group I: MAT- OBOT Active Control 1 Intervention

Those randomized to MAT standard of care will continue to receive standard office-based buprenorphine treatment.

Group II: MAT+ both CBT and CRS/Peer Support Specialist Active Control 1 Intervention

Those randomized to MAT+ office-based CBT will receive office-based buprenorphine treatment along with office-based CBT and a CRS.

Group III: MAT+ CRS/Peer Support Specialist Active Control 1 Intervention

Those randomized to MAT+ office-based CBT will receive office-based buprenorphine treatment along with a CRS.

Group IV: MAT+ office-based CBT Active Control 1 Intervention

Those randomized to MAT+ office-based CBT will receive office-based buprenorphine treatment along with office-based CBT.

Who Is Running the Clinical Trial?

Public Health Management Corporation

Lead Sponsor

Trials

18

Recruited

5,500+

Philadelphia College of Osteopathic Medicine

Collaborator

Trials

11

Recruited

1,300+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

Boston University

Collaborator

Trials

494

Recruited

9,998,000+

University of Pennsylvania

Collaborator

Trials

2,118

Recruited

45,270,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37682021/

Outcomes of adding cognitive behavioral therapy to ... Psychosocial interventions are reported to improve retention rates in rehabilitation centers with medication-assisted treatment (MAT) programs for opioid use.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2949875924000080

Cognitive behavioral therapy for anxiety and opioid use ... We developed a 12-session cognitive-behavioral treatment (CBT) for anxiety and opioid use disorder. · We compared CBT to Individual Drug Counseling (IDC), both ...

3. researchgate.net researchgate.net/publication/373773948_Outcomes_of_adding_cognitive_behavioral_therapy_to_medication-assisted_treatment_for_opioid_use_disorder

Outcomes of adding cognitive behavioral therapy to ... Psychosocial interventions are reported to improve retention rates in rehabilitation centers with medication-assisted treatment (MAT) programs for opioid use.

4. jsatjournal.com jsatjournal.com/article/S0740-5472%2817%2930482-8/fulltext

Effects of medication assisted treatment (MAT) for opioid ... First, very few studies of MAT reported functional outcomes; 40 MAT studies that met our study design criteria reported cognitive, physical, occupational social ...

5. psychiatrictimes.com psychiatrictimes.com/view/cognitive-behavior-therapy-and-medication-assisted-treatment-for-opioid-use-disorder

Cognitive Behavior Therapy and Medication-Assisted ... Cognitive behavior therapy (CBT) has been found to be helpful when used together with medication-assisted treatment (MAT). 7-9. One of the ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04257214

Therapy and Peer Support for Patients Taking Medication ... The study will evaluate the comparative effectiveness of two psychosocial approaches, Cognitive Behavioral Therapy and peer support through the use of Certified ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9175946/

Pharmacological and Behavioral Treatment of Opioid Use ... The gold standard is medication‐assisted treatment (MAT), wherein pharmacotherapy is combined with some form of counseling or behavioral therapy.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5553551/

Development of an Integrated Cognitive Behavioral ... The aims of the study are (1) to develop and pilot test a new manualized cognitive behavioral therapy for co-occurring opioid use disorder and anxiety disorders ...

9. aspe.hhs.gov aspe.hhs.gov/reports/psychosocial-supports-medication-assisted-treatment-recent-evidence-current-practice-0

Psychosocial Supports in Medication-Assisted Treatment The purpose of this report is to summarize current research findings and describe current practices of psychosocial supports in medication-assisted treatment ( ...