Peer-to-Peer Intervention for Substance Use Disorders

(P2P Trial)

Overseen By Abby Blackwell

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Prisma Health-Upstate

Must be taking: MOUD

Disqualifiers: Severe cognitive, medical, psychiatric disability, others

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

Compensation: Varies

Number of Visits: 12

Duration: 12 weeks

100 Participants Needed

Trial Summary

What is the purpose of this trial?

This study provides substance use and mental health peer support services to address behavioral health disparities in rural areas. Specifically, the project aims to address persistent mental health symptoms, such as anxiety and depression, that become barriers to care for patients working towards long-term recovery from co-occurring mental health and substance use disorders. Participants will be assessed and evaluated for opioid use disorder (OUD), social determinants of health (SDoH), and infectious diseases by a nurse practitioner and a social worker. A certified peer support specialist (CPSS) will provide additional support, connecting patients to sustainable mental health resources and implementing a modified version of the Friendship Bench intervention, which involves six weekly 45-minute problem-solving therapy sessions with the option to participate in six or more peer support sessions. The CPSS will follow the patient for up to 12 weeks.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, since participants must be receiving medication for opioid use disorder (MOUD) for at least 3 months, it seems you will need to continue that treatment.

What data supports the effectiveness of the P2P Intervention treatment for substance use disorders?

Research shows that digital therapies, which include peer interventions, can increase abstinence and retention in treatment for substance use disorders. A study found that using a digital therapeutic with reduced counseling led to higher abstinence rates compared to traditional treatment. ^{1 2 3 4 5}

Is the Peer-to-Peer Intervention for Substance Use Disorders safe for humans?

Research on digital therapeutic interventions for substance use disorders, which may include peer-to-peer elements, shows they are generally safe. A study found no significant difference in adverse events between those using a digital therapeutic and those receiving usual treatment. ^{3 5 6 7 8}

How is the P2P Intervention treatment for substance use disorders different from other treatments?

The P2P Intervention is unique because it involves peer support, where individuals with personal experience in overcoming substance use disorders help others going through similar challenges. This approach can reduce stigma, improve treatment satisfaction, and increase retention by providing relatable support and mentorship, which is different from traditional treatments that may not include peer involvement. ^{2 7 9 10 11}

Research Team

Alain Litwin

Principal Investigator

Prisma Health

Eligibility Criteria

This trial is for individuals with substance use disorders who are facing mental health challenges like anxiety and depression, particularly in rural areas. Participants should be dealing with co-occurring mental health and substance abuse issues, and will be evaluated for opioid use disorder, social factors affecting health, and infectious diseases.

Inclusion Criteria

I have moderate to severe depression, possibly with anxiety.

Diagnosis of OUD via Diagnostic Statistical Manual (DSM)-V Text Revision (TR)

I have been in the Mobile Recovery Program for at least 3 months.

Exclusion Criteria

Current suicidal ideation based on the Patient Health Questionnaire-9

Severe cognitive, medical, or psychiatric disability that could impair ability to perform study-related activities as determined by the MRP clinician or principal investigator

Unable to read and comprehend the consent materials and other study materials

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a modified version of the Friendship Bench intervention, involving six weekly 45-minute problem-solving therapy sessions and optional peer support sessions

12 weeks

6 CPSS-led therapy sessions, additional peer support sessions

Follow-up

Participants are monitored for reduction in depressive symptoms and other outcomes

12 weeks

Baseline, week 6, and week 12 visits

Treatment Details

Interventions

• P2P Intervention

Trial Overview The study tests a peer-to-peer intervention where certified support specialists provide six weeks of problem-solving therapy sessions plus optional ongoing peer support. The goal is to connect patients to long-term mental health resources and help them overcome barriers to recovery.

Participant Groups

Group I: P2P Intervention Experimental Treatment 1 Intervention

This group will complete the same study visits as the standard care group with an additional week 3 visit and 6 CPSS-led therapy intervention sessions. These CPSS led sessions will be completed by the end of the 12week study period. At each study visit you will complete questionnaires.

Group II: Standard of Care Active Control 1 Intervention

This group will complete a baseline, week 6, and week 12 study visit. Participants will complete research visits (in-person or virtually) at which time they will complete a series of questionnaires.

Who Is Running the Clinical Trial?

Prisma Health-Upstate

Lead Sponsor

Trials

91

Recruited

47,500+

South Carolina Center for Rural and Primary Healthcare

Collaborator

Trials

1

Recruited

100+

Findings from Research

The study demonstrated the feasibility of a semiautomated Patient Feedback system in outpatient substance abuse treatment clinics, achieving a 75.5% collection rate of patient data across 39 clinicians and 6 supervisors over a year-long study.

Clinicians generally received positive ratings for treatment satisfaction and therapeutic alliance, but one clinic showed significant improvement in self-reported drug use after implementing the system, indicating potential benefits of real-time patient feedback.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A feasibility study of a web-based performance improvement system for substance abuse treatment providers. Forman, R., Crits-Christoph, P., Kaynak, O., et al.[2019]

Web-based interventions for substance use disorders are currently under-researched, with no large randomized controlled trials available, indicating a significant gap in the evidence base for their effectiveness.

Despite the limited and flawed literature, there is a strong demand for internet-based interventions, suggesting they could be as effective as traditional therapy for less severe cases of substance use disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Web-based interventions for substance use disorders: a qualitative review. Copeland, J., Martin, G.[2006]

A digital therapeutic (DT) significantly increased abstinence rates among patients with substance use disorders (40.3% in the DT group vs. 17.6% in the treatment-as-usual group) over a 12-week period, indicating its efficacy in reducing substance use.

The DT also improved retention in treatment (76.2% vs. 63.2%), and importantly, there were no significant differences in adverse event rates between the DT and traditional treatment groups, suggesting it is a safe option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of a digital therapeutic for substance use disorder: Secondary analysis of data from a NIDA clinical trials network study. Maricich, YA., Nunes, EV., Campbell, ANC., et al.[2022]

In a pilot study involving 80 adults with recent non-fatal opioid overdoses, trained peer interventionists successfully delivered a Peer Recovery Support Services (PRSS) intervention, achieving a treatment enrollment success rate between 16% and 60%.

The interventionists reported no negative effects from their role, indicating that peer-led interventions can be implemented safely and effectively with limited training, although further research is needed to understand the factors influencing their varying success rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The feasibility and safety of training patients in opioid treatment to serve as peer recovery support service interventionists. Kropp, F., Wilder, C., Theobald, J., et al.[2022]

A study of 66 active cocaine users found that most participants reported regular Internet use, indicating that this population has similar rates of Internet access as the general public.

Younger individuals and those who use other drugs were more likely to be Internet users, suggesting that web-based interventions could be effectively targeted to reach cocaine users for treatment and research purposes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Profile of internet access in active cocaine users. Strickland, JC., Wagner, FP., Stoops, WW., et al.[2018]

In a study of 170 adults with opioid use disorder, those receiving a digital therapeutic alongside standard treatment had significantly higher rates of opioid abstinence (77.3% vs. 62.1%) during the final weeks of treatment.

The digital therapeutic also improved treatment retention, with participants less likely to leave treatment compared to those receiving standard care alone, while showing no increase in adverse events, indicating it is a safe and effective addition to traditional therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of a prescription digital therapeutic as an adjunct to buprenorphine for treatment of opioid use disorder. Maricich, YA., Bickel, WK., Marsch, LA., et al.[2022]

Peer-delivered services for substance use in low- and middle-income countries (LMICs) show potential in reducing risk behaviors and increasing knowledge about infectious diseases, based on a systematic review of 34 studies across four continents.

Despite some positive impacts, many studies indicated no significant differences in outcomes compared to control groups, highlighting the need for further research to better understand the effectiveness of these interventions in LMICs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peer-delivered services for substance use in low- and middle-income countries: A systematic review. Satinsky, EN., Kleinman, MB., Tralka, HM., et al.[2021]

A randomized clinical trial involving 85 participants evaluated the use of a Web-based videoconferencing platform for substance abuse counseling, showing that it is a feasible and acceptable alternative to in-person sessions.

Both Web-based and in-person counseling resulted in similar attendance rates and treatment satisfaction, indicating that online counseling can effectively extend access to treatment for individuals with reliable internet access.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized trial of Web-based videoconferencing for substance abuse counseling. King, VL., Brooner, RK., Peirce, JM., et al.[2021]

Peer recovery support services (PRSS) show promise in improving outcomes for individuals with substance use disorder (SUD), including reduced substance use, lower relapse rates, and increased treatment satisfaction, based on a systematic review of various studies.

However, the existing research has significant methodological limitations, such as inconsistent definitions of peer roles and a lack of appropriate comparison groups, highlighting the need for more rigorous studies to better understand the efficacy and implementation of PRSS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lived Experience in New Models of Care for Substance Use Disorder: A Systematic Review of Peer Recovery Support Services and Recovery Coaching. Eddie, D., Hoffman, L., Vilsaint, C., et al.[2023]

A peer-enhanced behavioral treatment called Peer-CRA was tested with 35 emerging adults, showing that both clients and their trained peers significantly increased their days of abstinence and reduced binge drinking over six months.

The treatment was delivered effectively, with high retention rates, suggesting that involving peers in substance use disorder treatment could be a promising approach that warrants further investigation in larger trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Six Month Outcomes of a Peer-Enhanced Community Reinforcement Approach for Emerging Adults with Substance Misuse: A Preliminary Study. Smith, DC., Davis, JP., Ureche, DJ., et al.[2019]

Internet-based treatment for substance use disorders, such as alcohol and cannabis problems, offers unique advantages and challenges compared to face-to-face therapy, as highlighted by focus group interviews with 12 therapists.

Key differences include communication styles, the impact of anonymity, and the use of time, which all affect the therapeutic alliance and require therapists to adapt their skills for effective online treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sort of a nice distance: a qualitative study of the experiences of therapists working with internet-based treatment of problematic substance use. Ekström, V., Johansson, M.[2020]

References

1. United States pubmed.ncbi.nlm.nih.gov

A feasibility study of a web-based performance improvement system for substance abuse treatment providers. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Web-based interventions for substance use disorders: a qualitative review. [2006]

3. United States pubmed.ncbi.nlm.nih.gov

Safety and efficacy of a digital therapeutic for substance use disorder: Secondary analysis of data from a NIDA clinical trials network study. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

The feasibility and safety of training patients in opioid treatment to serve as peer recovery support service interventionists. [2022]

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

Profile of internet access in active cocaine users. [2018]

6. England pubmed.ncbi.nlm.nih.gov

Safety and efficacy of a prescription digital therapeutic as an adjunct to buprenorphine for treatment of opioid use disorder. [2022]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Peer-delivered services for substance use in low- and middle-income countries: A systematic review. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

A randomized trial of Web-based videoconferencing for substance abuse counseling. [2021]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Lived Experience in New Models of Care for Substance Use Disorder: A Systematic Review of Peer Recovery Support Services and Recovery Coaching. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Six Month Outcomes of a Peer-Enhanced Community Reinforcement Approach for Emerging Adults with Substance Misuse: A Preliminary Study. [2019]

11. England pubmed.ncbi.nlm.nih.gov

Sort of a nice distance: a qualitative study of the experiences of therapists working with internet-based treatment of problematic substance use. [2020]