Therapy and Peer Support for Opioid Use Disorder

Not currently recruiting at 4 trial locations

Overseen By Sandra Festa, M.S.W.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Philadelphia College of Osteopathic Medicine

Must be taking: Buprenorphine

Disqualifiers: Intoxicated, Cognitively impaired, Psychiatrically unstable, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to identify the most effective psychosocial treatments to pair with medication for individuals with opioid use disorder (OUD). It will evaluate various approaches, such as regular treatment, cognitive behavioral therapy (CBT), peer support, or combinations of these, to determine which works best alongside standard medication. Eligible participants include those already suitable for buprenorphine treatment for OUD who do not require inpatient care. The goal is to discover which therapies benefit different patients the most, enhancing treatment effectiveness and personalization. As an unphased trial, this study provides an opportunity to contribute to research that could improve personalized treatment options for OUD.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on treatment with buprenorphine for opioid use disorder, so it's best to discuss your current medications with the trial team.

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

Research shows that Cognitive Behavioral Therapy (CBT) is generally safe for people with opioid use disorder. Studies indicate that patients handle this therapy well, with rare and mild side effects.

Evidence also supports the safety of peer support from Certified Recovery Specialists (CRS). Reviews suggest that these programs help reduce substance use and improve treatment retention. Interactions with peers are usually positive and supportive.

Research on combining CBT and CRS is promising. Studies show that this approach helps people stay engaged in treatment without increasing side effects compared to using each method alone.

Overall, these treatments appear safe and well-tolerated for managing opioid use disorder. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for opioid use disorder because they combine psychosocial approaches with standard care, potentially enhancing recovery outcomes. Standard treatments often rely solely on medication-assisted therapy (MAT), like methadone or buprenorphine. However, this trial explores integrating Cognitive Behavioral Therapy (CBT) and peer support, which could address not just the physical but also the psychological aspects of addiction. The combination of CBT with certified recovery specialists (CRS) or peer support specialists (CPS) aims to provide comprehensive support and personalized strategies for overcoming addiction. This multifaceted approach could lead to more sustainable recovery by targeting both the mind and the social environment of individuals.

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

Research has shown that Cognitive Behavioral Therapy (CBT), one of the treatment options in this trial, can significantly aid individuals with opioid use disorder. One study found that patients using CBT remained drug-free for more than twice as long as those who did not. Another treatment arm in this trial includes programs with Certified Recovery Specialists (CRS) or Peer Support Specialists (CPS), which have also proven effective. Specifically, one study found that 88.6% of participants in a peer support program continued their treatment, about 28.9% more than those not in the program. This trial will also explore combining CBT with peer support, offering a comprehensive approach that may enhance treatment participation and reduce opioid use over time. These methods focus on assisting patients through both structured therapy and community support, which can be crucial for recovery. ^{1 2 3 4 6}

Who Is on the Research Team?

Michelle R Lent, Ph.D.

Principal Investigator

Philadelphia College of Osteopathic Medicine

Are You a Good Fit for This Trial?

This trial is for adults over 18 with opioid use disorder who are eligible and agree to buprenorphine treatment. They must be stable enough not to need inpatient care, able to give informed consent, and provide contact information. People intoxicated, cognitively impaired or psychiatrically unstable at the start are excluded but can join later if conditions improve.

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 can provide my contact details and understand the consent form.

Exclusion Criteria

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

DSM 5 criteria for OUD include: Taking opioids in larger amounts or longer than intended, Failed efforts to quit or cut back, Spending a lot of time obtaining the opioid, Craving or urges to use, Repeated inability to carry out major work, school, or home obligations, Continued use despite persistent or recurring interpersonal problems worsened by opioid use, Stopping or reducing important social, recreational activities due to opioid use, Recurrent use of opioids in physically hazardous situations, Continued opioid use despite knowledge of having a persistent or recurrent physical or psychological problem that is likely to have been caused or exacerbated by the substance, Tolerance, and Withdrawal. Moderate OUD severity is denoted by the presence of 4 or 5 of these symptoms and severe OUD is denoted by 6 or more symptoms. Patients will be excluded from the study if their SUD is primarily for a different substance, or their co-morbid psychiatric needs indicate enhanced 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/CPS, or both CBT and CRS/CPS

12 months

Weekly visits until stable, then monthly

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Psychosocial treatment

Trial Overview The study tests different psychosocial treatments alongside medication-assisted treatment (MAT) for opioid addiction. It aims to find out which psychosocial approaches work best for various patients rather than using a standard method for all.

How Is the Trial Designed?

Group I: Treatment as usual Active Control 1 Intervention

Those randomized to treatment as usual will receive standard treatment from one of four FQHC sites.

Group II: Office based CBT Active Control 1 Intervention

Those randomized to Cognitive Behavioral Treatment will receive cognitive behavioral treatment (CBT) along with standard treatment from the FQHC.

Group III: CRS/CPS Active Control 1 Intervention

Those randomized to certified recovery specialist(CRS)/peer support specialist(CPS) will receive a CRS/CPS along with standard treatment from the FQHC.

Group IV: CBT+CRS/CPS 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.

Who Is Running the Clinical Trial?

Philadelphia College of Osteopathic Medicine

Lead Sponsor

Trials

11

Recruited

1,300+

Boston University

Collaborator

Trials

494

Recruited

9,998,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

Public Health Management Corporation

Collaborator

Trials

18

Recruited

5,500+

University of Pennsylvania

Collaborator

Trials

2,118

Recruited

45,270,000+

Published Research Related to This Trial

A qualitative study involving 26 patients receiving methadone treatment found that a peer recovery specialist-delivered behavioral activation intervention (Peer Activate) was perceived as acceptable and feasible, particularly due to its flexibility and the supportive qualities of the peer specialists.

Participants highlighted the importance of connecting with the intervention content and building skills, while also noting stigma related to substance use and methadone treatment as barriers to engagement, suggesting that addressing these issues could enhance treatment retention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"You rise up and then you start pulling people up with you": Patient experiences with a peer-delivered behavioral activation intervention to support methadone treatment. Kleinman, MB., Hines, AC., Anvari, MS., et al.[2023]

A pilot randomized controlled trial involving 25 hospitalized adults with opioid use disorder (OUD) tested a peer recovery coach intervention to improve retention in medications for opioid use disorder (MOUD) after discharge.

The study found no significant differences in MOUD retention rates, hospital readmissions, or time to treatment discontinuation between the recovery coach intervention group and the treatment-as-usual group, indicating that the intervention did not enhance treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Peer Recovery Coach Intervention for Hospitalized Patients with Opioid Use Disorder: A Pilot Randomized Controlled Trial. Suzuki, J., Martin, B., Loguidice, F., et al.[2023]

Peer recovery support services (PRSS) have been integrated into the recovery process for opioid use disorder (OUD), but their effectiveness on clinical outcomes remains unclear, as only 12 out of 123 studies met the inclusion criteria for review.

Most studies reported on PRSS engagement and medication for OUD (MOUD) initiation, but findings were inconsistent and varied due to the lack of standardized PRSS interventions and methodological limitations, indicating a need for further research before widespread implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of peer recovery support services on stages of the opioid use disorder treatment cascade: A systematic review. Gormley, MA., Pericot-Valverde, I., Diaz, L., et al.[2022]

This study will evaluate the effectiveness of behavioral interventions for opioid use disorder (OUD) delivered by certified peer recovery support specialists versus licensed clinical social workers (LCSWs) in a randomized trial involving 650 high-risk patients over 18 months.

The primary goals are to measure how well these interventions promote engagement in OUD treatment within 30 days and reduce recurrent emergency department visits for opioid overdose within 18 months, providing valuable insights into effective treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomised clinical trial of an emergency department-based peer recovery support intervention to increase treatment uptake and reduce recurrent overdose among individuals at high risk for opioid overdose: study protocol for the navigator trial. Goedel, WC., Marshall, BDL., Samuels, EA., et al.[2023]

The Community Reinforcement Approach and Family Training for Treatment Retention (CRAFT-T) showed a moderate effect on improving treatment retention for opioid-dependent adults, particularly when the concerned significant other was a parent, where it had a significant impact (p<0.01).

CRAFT-T also significantly reduced opioid and other drug use among participants, indicating its potential efficacy as a treatment intervention for opioid use disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized pilot clinical trial to evaluate the efficacy of Community Reinforcement and Family Training for Treatment Retention (CRAFT-T) for improving outcomes for patients completing opioid detoxification. Brigham, GS., Slesnick, N., Winhusen, TM., et al.[2021]

A 20-minute telephone-delivered peer recovery support service (PRSS) intervention led to a higher enrollment in medication for opioid use disorder (MOUD) among participants, with 32.5% of PRSS participants enrolling compared to 17.5% in the control group.

Participants receiving PRSS were significantly less likely to experience an opioid overdose (OOD) within 12 months, with only 12.5% reporting an OOD compared to 32.5% in the control group, indicating the potential effectiveness of PRSS in enhancing safety for individuals with opioid use disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A brief telephone-delivered peer intervention to encourage enrollment in medication for opioid use disorder in individuals surviving an opioid overdose: Results from a randomized pilot trial. Winhusen, T., Wilder, C., Kropp, F., et al.[2022]

Citations

1. 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9097607/

Rationale, design, and methodology of a randomized pilot ... The OVERCOME study is a randomized clinical trial (RCT) aimed to tests an integrated intervention combining CBT4CBT and Recovery Coaching relative to treatment ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0955395922002298

Peer recovery specialist-delivered, behavioral activation ... This hybrid effectiveness-implementation pilot trial aimed to demonstrate the proof of concept of a peer recovery specialist-delivered behavioral activation.

4. trialx.com trialx.com/clinical-trials/listings/254329/therapy-and-peer-support-for-patients-taking-medication-for-opioid-use-disorder/

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 ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8117118/

Collaborative Care in the Treatment of Opioid Use Disorder ... ... Certified Recovery Specialist to help with treatment engagement and retention. Primary outcomes are six-month rates of opioid use and six-month rates of ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03367234

Patient-Centered Care for Opioid Use Disorders in ... This study evaluates the effectiveness of integrating empirically-supported treatments for an opioid use disorder into a primary care setting.