Therapy and Peer Support for Opioid Use Disorder

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

340 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Current clinical guidelines for medication assisted treatment (MAT) of opioid use disorder (OUD) recommend that treatment include a psychosocial component to help address psychological factors related to addiction. However, a knowledge gap exists regarding the most effective forms of psychosocial intervention and what interventions are most effective for different types of patients. This gap represents a significant barrier to the widespread implementation of effective office-based opioid treatment (OBOT) with buprenorphine, which is important to improving opioid treatment and responding to the critical needs of individuals living with OUD. The overarching goal of this patient-centered research is to address the diverse needs and preferences of OUD patients in regards to psychosocial approaches and to overcome the "one-size-fits-all" strategies that are typically used to treat OUD. Importantly, investigators arrived at this goal, in part, through collaboration and consultation with former patients who have received different types of treatments for OUD. In this manner, patients provided important insight to inform the selection of interventions to be evaluated, patient characteristics that may differentially impact the effects of the interventions, and the patient outcomes to be examined.

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 therapy and peer support for opioid use disorder safe for humans?

Research on therapy and peer support for opioid use disorder, often called psychosocial interventions, suggests they are generally safe for humans. These interventions have been used in various settings, such as hospitals and emergency departments, to support individuals with opioid use disorder. ^{1 2 3 4 5}

How is the psychosocial treatment for opioid use disorder different from other treatments?

This treatment is unique because it combines therapy with peer support, where individuals with personal experience in recovery help others, which can improve retention in medication-assisted treatment. Unlike standard treatments that focus solely on medication, this approach emphasizes the importance of social support and behavioral interventions to enhance recovery outcomes. ^{1 2 4 6 7}

What data supports the effectiveness of the treatment Psychosocial treatment for Opioid Use Disorder?

Research shows that psychosocial interventions, including peer support, can help people with opioid use disorder stay in treatment longer and reduce drug use. Studies also suggest that having a strong connection with counselors and peers can improve treatment outcomes. ^{1 2 6 8 9}

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 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]

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 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]

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]

Citations

1. Netherlands pubmed.ncbi.nlm.nih.gov

A Peer Recovery Coach Intervention for Hospitalized Patients with Opioid Use Disorder: A Pilot Randomized Controlled Trial. [2023]

2. Ireland pubmed.ncbi.nlm.nih.gov

Effectiveness of peer recovery support services on stages of the opioid use disorder treatment cascade: A systematic review. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Challenges on the road to recovery: Exploring attitudes and experiences of clients in a community-based buprenorphine program in Baltimore City. [2020]

4. Ireland pubmed.ncbi.nlm.nih.gov

Forty-eight years of research on psychosocial interventions in the treatment of opioid use disorder: A scoping review. [2021]

5. England pubmed.ncbi.nlm.nih.gov

The relationship of counselor and peer alliance to drug use and HIV risk behaviors in a six-month methadone detoxification program. [2019]

6. England 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. [2023]

7. Netherlands 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. [2023]

8. Ireland 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. [2022]

9. Ireland 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. [2021]