Launch Program for Polysubstance Drug Use

(Launch Trial)

Overseen By Tess K Drazdowski, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Chestnut Health Systems

Disqualifiers: Unstable conditions, Suicidal intentions, others

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

Compensation: Varies

Number of Visits: 20

Duration: 6 months

48 Participants Needed

Trial Summary

What is the purpose of this trial?

Emerging adults (EAs; aged 18-26) are the highest-risk population for poly-substance use (misuse of more than one drug), compared to all other age groups and are the least-served population for substance use services. The overarching purpose of this pilot study is to assess whether an innovative services package, Launch, can reasonably work (is feasible) and whether providers and participants like it (acceptability). Launch works with both EAs and a supportive parent (or parental figure) and delivers peer recovery support services (PRSS) to EAs while helping parents use an effective, evidence-based program called contingency management, adapted for EAs, at home with their EA child. This study will also lay the groundwork for a future large-scale trial of Launch services.

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 might be best to discuss this with the trial coordinators or your healthcare provider.

What data supports the effectiveness of the treatment Contingency Management for Emerging Adults (CM-EA) for polysubstance drug use?

Research shows that Contingency Management (CM) is effective in treating substance use disorders, including in adolescents and veterans, by using rewards to encourage positive behaviors like abstinence and treatment adherence. This approach has been successfully implemented in various settings, indicating its potential effectiveness for polysubstance use. ^{1 2 3 4 5}

Is the Launch Program for Polysubstance Drug Use generally safe for humans?

The safety data from a study on behavioral treatment for heroin and cocaine dependence, which may be similar to the Launch Program, showed that adverse events (unwanted effects) were reported but were mostly not serious. Common issues included infections, stomach problems, and muscle or joint pain, with serious problems being rare. ^{6 7 8 9 10}

How is the Launch Program for Polysubstance Drug Use treatment different from other treatments?

The Launch Program combines Contingency Management (CM), which rewards positive behavior like staying drug-free, with Peer Recovery Support Services (PRSS) and Vocational/Educational Skill Building, making it unique by addressing both substance use and life skills development. This integrated approach is not commonly found in other treatments, which often focus solely on substance use. ^{2 11 12 13 14}

Research Team

Tess K Drazdowski, PhD

Principal Investigator

Chestnut Health Systems

Eligibility Criteria

This trial is for young adults aged 18-26 who are struggling with using multiple drugs. They must have a supportive parent or parental figure willing to participate. The study aims to test if the 'Launch' program, which includes peer support and helps parents use contingency management at home, is feasible and acceptable.

Inclusion Criteria

I am over 18, a certified peer worker, and willing to learn and help in research.

I am over 18 and work in an admin role at an organization involved in recovery services.

I am 18-26, misused drugs recently, have a substance use disorder, and a supportive adult willing to help me.

Exclusion Criteria

Only EAs that present with unstable conditions requiring intensive treatment, such as hospital interventions, will be excluded from the sample. Examples of these conditions include participant reports of active suicidal or homicidal intentions or requests for medically supervised detox services

Not applicable.

N/A

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Virtual Parent Contingency Management for Emerging Adults (CM-EA), In-Person Peer Recovery Support Services (PRSS), or a combination of both for 6 months

6 months

Weekly sessions (20-40 minutes for CM-EA, 1 hour for PRSS)

Follow-up

Participants are monitored for changes in recovery capital, substance use, and quality of life

6 months

Extension

Interviews with payors and providers to gather economic-related information for future large-scale study

Up to 2 years

Treatment Details

Interventions

• Contingency Management for Emerging Adults (CM-EA)
• Standard Peer Recovery Support Services (PRSS) +Vocational/Educational (V/E) Skill Building services

Trial Overview The 'Launch' services package is being tested for its effectiveness in aiding recovery from polysubstance use among emerging adults. It combines Contingency Management adapted for this age group (CM-EA) with Standard Peer Recovery Support Services plus Vocational/Educational Skill Building services.

Participant Groups

Group I: Standard Peer Recovery Support Services (PRSS)+Vocational/Educational (V/E) Skill Building Experimental Treatment 1 Intervention

The EAs in this group will receive PRSS+Vocational/Educational (V/E) Skill Building delivered by peer workers in-person in the local community approximately weekly (1 hour sessions) for 6 months.

Group II: Contingency Management for Emerging Adults (CM-EA) Only Experimental Treatment 1 Intervention

The parents in this group will receive CM-EA delivered virtually by a parent coach approximately weekly (20-40 minute sessions) for 6 months.

Group III: CM-EA and PRSS+V/E Experimental Treatment 2 Interventions

Families receive both CM-EA and PRSS + V/E as described above.

Contingency Management for Emerging Adults (CM-EA) is already approved in United States for the following indications:

Approved in United States as Contingency Management for:

• Substance use disorder
• Poly-substance use

Who Is Running the Clinical Trial?

Chestnut Health Systems

Lead Sponsor

Trials

27

Recruited

24,500+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Findings from Research

Contingency management (CM) is an emerging treatment for adolescent substance abuse that uses systematic rewards to encourage positive behavior changes, supported by strong scientific evidence.

While research on CM for adolescents is still developing, there is optimism about its potential effectiveness based on foundational principles and early clinical studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contingency management approaches for adolescent substance use disorders. Stanger, C., Budney, AJ.[2021]

The Department of Veterans Affairs successfully implemented contingency management (CM) for substance use disorders across 94 stations, reaching 2060 patients, with high fidelity to CM practices and an average of 6.5 coaching calls per program.

Patients attended over half of their scheduled CM sessions, achieving a remarkable 91.1% negative urine test rate for the target substance, indicating that the initiative produced effective outcomes similar to those seen in controlled clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The national implementation of Contingency Management (CM) in the Department of Veterans Affairs: Attendance at CM sessions and substance use outcomes. DePhilippis, D., Petry, NM., Bonn-Miller, MO., et al.[2020]

Contingency management (CM) has been shown to effectively improve outcomes for substance-abusing adolescents, with a study involving 86 participants who selected from 1,739 activities across various goal areas.

The adolescents completed an average of 13 out of 20 chosen activities, achieving a completion rate of 64%, indicating that activity incentive programs can be a feasible and effective approach for promoting abstinence and treatment adherence in this age group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contingent reinforcement of personal goal activities for adolescents with substance use disorders during post-residential continuing care. Godley, SH., Godley, MD., Wright, KL., et al.[2021]

The study evaluated a novel contingency management intervention called conditional budgets (CB) for patients in a supervised injectable opioid treatment clinic, highlighting the importance of patient motivation and trust in the treatment system for effective intervention delivery.

While the intervention aimed to reduce drug use, its effectiveness was hard to measure, as positive outcomes like improved psychological wellbeing and staff satisfaction were noted, but there were also challenges such as patient relapse and increased staff workload.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Qualitative evaluation of a novel contingency management-related intervention for patients receiving supervised injectable opioid treatment. Neale, J., Tompkins, CN., Strang, J.[2019]

In a study involving 214 chronic heroin-dependent patients, adding contingency management (CM) to standard heroin-assisted treatment (HAT) significantly increased the duration of cocaine abstinence, with an average of 3.7 weeks for HAT+CM compared to 1.6 weeks for HAT-only.

The high retention rate in treatment (91.6%) was consistent across both groups, indicating that the addition of CM did not negatively impact overall treatment adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of cocaine contingency management in heroin-assisted treatment: Results of a randomized controlled trial. Blanken, P., Hendriks, VM., Huijsman, IA., et al.[2019]

In a study of 1,037 urban Emergency Department patients, 53% of males and 60% of females reported experiencing one or more adverse childhood experiences (ACEs), highlighting a significant prevalence of trauma in this population.

The research found that females with a history of maternal domestic violence had higher odds of at-risk drinking, and cumulative ACEs were linked to increased cannabis and illicit drug use among females, indicating a stronger association between ACEs and substance use in women compared to men.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse childhood experiences are associated with at-risk drinking, cannabis and illicit drug use in females but not males: an Emergency Department study. Cunradi, CB., Caetano, R., Alter, HJ., et al.[2021]

Over half of adolescents in the U.S. have been exposed to adverse childhood experiences (ACEs), which can lead to serious issues like learning difficulties, behavioral problems, and suicidal thoughts.

To effectively support these adolescents, health, education, and social welfare systems must coordinate services that are trauma-informed and tailored to their unique developmental needs, including addressing confidentiality and independence concerns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse Childhood Experiences and Resilience: Addressing the Unique Needs of Adolescents. Soleimanpour, S., Geierstanger, S., Brindis, CD.[2022]

The community-based learning collaborative (CBLC) model, developed as part of Project BEST, effectively promotes the implementation of trauma-focused practices among 1,190 participants across 13 collaborative groups, highlighting its potential for sustainable trauma-informed care.

Data from the third phase of Project BEST showed significant increases in the use of trauma-focused practices and positive feedback on the utility of the CBLC components, indicating that this model is both feasible and effective in enhancing trauma treatment delivery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Statewide implementation of child trauma-focused practices using the community-based learning collaborative model. Hanson, RF., Saunders, BE., Ralston, E., et al.[2020]

A phase II trial involving 92 adults showed that a 12-week ACE Overcomers program significantly improved emotion regulation, psychological resilience, mental well-being, and reduced physical symptoms, indicating its efficacy for those with Adverse Childhood Experiences (ACEs).

Both faith-based and secular versions of the program produced similar positive outcomes, suggesting that the intervention's approach is effective regardless of the context, and younger participants experienced greater reductions in perceived stress.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of an intervention promoting emotion regulation skills for adults with persisting distress due to adverse childhood experiences. Cameron, LD., Carroll, P., Hamilton, WK.[2019]

In a 29-week outpatient study involving 286 participants with heroin and cocaine dependence, a total of 884 adverse events (AEs) were reported, averaging 3.1 AEs per patient, with infections being the most common type (26.8%).

Serious AEs were rare, occurring in only 1.6% of participants, and the incidence of AEs varied significantly by demographics, with female participants reporting more AEs, while African Americans and those over 40 reported fewer, indicating that demographic factors may influence safety outcomes in substance dependence trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events among patients in a behavioral treatment trial for heroin and cocaine dependence: effects of age, race, and gender. Schroeder, JR., Schmittner, JP., Epstein, DH., et al.[2022]

Contingency management (CM) is an effective treatment for substance use disorders, but it is still not widely used in practice despite strong evidence supporting its efficacy across various populations.

The Department of Veterans Affairs has successfully implemented CM on a large scale, providing a model for training and supervision that could enhance the fidelity of CM's application in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Considerations for Implementing Contingency Management in Substance Abuse Treatment Clinics: The Veterans Affairs Initiative as a Model. Rash, CJ., DePhilippis, D.[2021]

Contingency management (CM) is a highly effective intervention for stimulant use and works well with medication for opioid use disorder, yet its implementation in opioid treatment programs is surprisingly low, highlighting a significant gap in addiction health services.

This study will evaluate a multi-level implementation strategy called the Science of Service Laboratory (SSL) across 10 opioid treatment programs to promote CM, using a robust trial design to assess both implementation and patient outcomes over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing contingency management for stimulant use in opioid treatment programs: protocol of a type III hybrid effectiveness-stepped-wedge trial. Becker, SJ., DiClemente-Bosco, K., Scott, K., et al.[2023]

Remote delivery of contingency management (CM) for substance use treatment has been shown to improve outcomes such as abstinence and engagement in treatment, similar to in-person CM, based on a systematic review of 39 studies.

The majority of these studies (57.5%) were of strong quality, indicating that remote CM is not only feasible across various digital platforms but also effective in reducing barriers to treatment access for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of remotely delivered contingency management treatment for substance use. Coughlin, LN., Salino, S., Jennings, C., et al.[2023]

Contingency management (CM) has been effectively implemented at a large U.S. Department of Veterans Affairs Addiction Treatment Center to encourage abstinence from substance use, highlighting its role as an evidence-based intervention.

The implementation faced challenges such as staff acceptance, initial referral limitations, and the need for proper training and resources, but local innovations have helped expand CM since its introduction in 2012.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of Contingency Management at a Large VA Addiction Treatment Center. Ruan, H., Bullock, CL., Reger, GM.[2018]

References

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

Contingency management approaches for adolescent substance use disorders. [2021]

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

The national implementation of Contingency Management (CM) in the Department of Veterans Affairs: Attendance at CM sessions and substance use outcomes. [2020]

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

Contingent reinforcement of personal goal activities for adolescents with substance use disorders during post-residential continuing care. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Qualitative evaluation of a novel contingency management-related intervention for patients receiving supervised injectable opioid treatment. [2019]

5. Ireland pubmed.ncbi.nlm.nih.gov

Efficacy of cocaine contingency management in heroin-assisted treatment: Results of a randomized controlled trial. [2019]

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

Adverse childhood experiences are associated with at-risk drinking, cannabis and illicit drug use in females but not males: an Emergency Department study. [2021]

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

Adverse Childhood Experiences and Resilience: Addressing the Unique Needs of Adolescents. [2022]

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

Statewide implementation of child trauma-focused practices using the community-based learning collaborative model. [2020]

9. England pubmed.ncbi.nlm.nih.gov

Evaluation of an intervention promoting emotion regulation skills for adults with persisting distress due to adverse childhood experiences. [2019]

10. Ireland pubmed.ncbi.nlm.nih.gov

Adverse events among patients in a behavioral treatment trial for heroin and cocaine dependence: effects of age, race, and gender. [2022]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Considerations for Implementing Contingency Management in Substance Abuse Treatment Clinics: The Veterans Affairs Initiative as a Model. [2021]

12. England pubmed.ncbi.nlm.nih.gov

Implementing contingency management for stimulant use in opioid treatment programs: protocol of a type III hybrid effectiveness-stepped-wedge trial. [2023]

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

A systematic review of remotely delivered contingency management treatment for substance use. [2023]

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

Implementation of Contingency Management at a Large VA Addiction Treatment Center. [2018]