Launch Program for Polysubstance Drug Use
(Launch Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Chestnut Health Systems
Disqualifiers: Unstable conditions, Suicidal intentions, others
No Placebo Group
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.12345
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.678910
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.211121314
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.
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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
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Trial 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) (Behavioral Intervention)
- Standard Peer Recovery Support Services (PRSS) +Vocational/Educational (V/E) Skill Building services (Behavioral Intervention)
Trial OverviewThe '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
3Treatment groups
Experimental Treatment
Group I: Standard Peer Recovery Support Services (PRSS)+Vocational/Educational (V/E) Skill BuildingExperimental Treatment1 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) OnlyExperimental Treatment1 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/EExperimental Treatment2 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Chestnut Health SystemsEugene, OR
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Who Is Running the Clinical Trial?
Chestnut Health SystemsLead Sponsor
National Institute on Drug Abuse (NIDA)Collaborator
References
Contingency management approaches for adolescent substance use disorders. [2021]The addition of contingency management (CM) to the menu of effective treatments for adolescent substance abuse has generated excitement in the research and treatment communities. CM interventions are based on extensive basic science and clinical research evidence demonstrating that drug use is sensitive to systematically applied consequences. This article provides (a) a review of basic CM principles, (b) implementation guidelines, (c) a review of the clinical CM research targeting adolescent substance abuse, and (d) a discussion of implementation successes and challenges. Although the research base for CM with adolescents is in its infancy, there are multiple reasons for high expectations.
The national implementation of Contingency Management (CM) in the Department of Veterans Affairs: Attendance at CM sessions and substance use outcomes. [2020]In 2011, the Department of Veterans Affairs launched an initiative to expand patients' access to contingency management (CM) for the treatment of substance use disorders, particularly stimulant use disorder. This study evaluates the uptake and effectiveness of the VA initiative by presenting data on participation in coaching, fidelity to key components of the CM protocol, and clinical outcomes (CM attendance and substance use).
Contingent reinforcement of personal goal activities for adolescents with substance use disorders during post-residential continuing care. [2021]Contingency management (CM) is efficacious in improving outcomes of substance-abusing patients, but CM studies are relatively rare in adolescents. CM approaches can reinforce both abstinence and adherence to treatment-related goal areas. This paper describes 1,739 different activities in 10 goal areas (e.g., education, family/friends, and social/recreational) chosen by 86 adolescents who were participating in a multiple week CM study that reinforced both abstinence and adherence with goal-related activities. The mean activities selected was 20, and the mean completed was 13. Overall, 1,114 or 64% of chosen activities were completed. The clinical feasibility of activity incentive programs for adolescents is discussed.
Qualitative evaluation of a novel contingency management-related intervention for patients receiving supervised injectable opioid treatment. [2019]To evaluate a novel contingency management (CM)-related intervention for people experiencing complex drug problems, thereby increasing understanding of CM implementation in real-world settings. Objectives are to provide new insights into (i) how context influences intervention delivery; (ii) aspects of intervention delivery that influence outcomes; and (iii) intervention outcomes.
Efficacy of cocaine contingency management in heroin-assisted treatment: Results of a randomized controlled trial. [2019]To determine the efficacy of contingency management (CM), targeting cocaine use, as an add-on intervention for heroin dependent patients in supervised heroin-assisted treatment (HAT) with frequent cocaine use.
Adverse childhood experiences are associated with at-risk drinking, cannabis and illicit drug use in females but not males: an Emergency Department study. [2021]Adverse childhood experiences (ACEs) are associated with adult substance use in the general population. Given pervasive health disparities among underserved populations, understanding how ACEs are associated with substance use among urban Emergency Department (ED) patients could help inform design of effective screening, brief interventions, and referral to treatment.
Adverse Childhood Experiences and Resilience: Addressing the Unique Needs of Adolescents. [2022]Adolescents exposed to adverse childhood experiences (ACEs) have unique developmental needs that must be addressed by the health, education, and social welfare systems that serve them. Nationwide, over half of adolescents have reportedly been exposed to ACEs. This exposure can have detrimental effects, including increased risk for learning and behavioral issues and suicidal ideation. In response, clinical and community systems need to carefully plan and coordinate services to support adolescents who have been exposed to ACEs, with a particular focus on special populations. We discuss how adolescents' needs can be met, including considering confidentiality concerns and emerging independence; tailoring and testing screening tools for specific use with adolescents; identifying effective multipronged and cross-system trauma-informed interventions; and advocating for improved policies.
Statewide implementation of child trauma-focused practices using the community-based learning collaborative model. [2020]A significant number of youth in the United States experience traumatic events that substantially increase the risk of physical and behavioral health problems across the life span. This public health concern warrants concerted efforts to promote trauma-informed, evidence-based practices that facilitate recovery. Although youth-focused trauma-specific treatments exist, determining effective ways to disseminate and implement these services-so that they are available, accessible, and sustainable-poses an ongoing challenge. This paper describes a comprehensive model for such implementation, the community-based learning collaborative (CBLC), developed as part of Project BEST, a four-phase statewide initiative to promote trauma-focused practices. The CBLC augments the learning collaborative model by including clinical and nonclinical (i.e., broker) professionals from multiple service organizations within a targeted community. CBLCs aim to build capacity for sustained implementation of trauma-focused practices by promoting interprofessional collaboration among those involved in the coordination and provision of these services. This paper describes the iterative development of the CBLC by examining participant completion data across the three completed phases of Project BEST (N = 13 CBLCs; 1,190 participants). Additionally, data from Project BEST's third phase (N = 6 CBLCs; 639 participants) were used to evaluate changes in the frequency of specific practices, pre- to post-CBLC, and post-CBLC perceived utility of CBLC components. High participant completion rates, significant increases in reported trauma-focused practices, and positive ratings of the CBLC's utility provisionally support the feasibility and efficacy of the model's final iteration. Implications for implementation and CBLC improvements are discussed. (PsycINFO Database Record (c) 2019 APA, all rights reserved).
Evaluation of an intervention promoting emotion regulation skills for adults with persisting distress due to adverse childhood experiences. [2019]This phase II trial evaluated psychosocial and health outcomes of an intervention designed to improve emotion regulation skills in adults suffering from Adverse Childhood Experiences (ACEs). The study utilized a pretest-posttest design in which 92 adults enrolled in the community-based program completed pretest measures, attended either a faith-based or secular version of the 12-week ACE Overcomers program, and then completed posttest measures. The theory-guided program involved group sessions providing education and skills training to improve emotion regulation, self-awareness, resilience, and social functioning. Pretest and posttest surveys included measures of emotional regulation (suppression, rumination, cognitive reappraisal, and mindfulness), resilience (ego resilience and general self-efficacy), emotional experiences (perceived stress, moods, and depressive symptoms), quality of life (the SF-36 domains), and physical symptoms and illness (symptom load and sick days). Analyses revealed significant improvements from pretest to posttest in all facets of emotion regulation (p
Adverse events among patients in a behavioral treatment trial for heroin and cocaine dependence: effects of age, race, and gender. [2022]Safety monitoring is a critical element of clinical trials evaluating treatment for substance dependence, but is complicated by participants' high levels of medical and psychiatric comorbidity. This paper describes AEs reported in a large (N = 286), 29-week outpatient study of behavioral interventions for heroin and cocaine dependence in methadone-maintained outpatients. A total of 884 AEs were reported (3.1 per patient, 0.12 per patient-week), the most common being infections (26.8%), gastrointestinal (20.5%), musculoskeletal (12.3%), and general (10%) disorders. Serious AEs were uncommon (1.6% of total). Female participants reported significantly higher rates of AEs (incidence density ratio, IDR = 1.38, p
Considerations for Implementing Contingency Management in Substance Abuse Treatment Clinics: The Veterans Affairs Initiative as a Model. [2021]Contingency management (CM) is an efficacious intervention for the treatment of substance use disorders that is widely applicable across a range of client populations and characteristics. Despite its strong evidence base, CM remains underutilized in real world practice. This article introduces CM for clinicians interested in adopting CM and briefly reviews this research evidence. In addition, CM protocols are described, with emphasis on the specific design considerations important to CM's efficacy. The recent Department of Veterans Affairs (VA) initiative, which represents the first successful large-scale implementation effort, is presented. It provides a model for the training and supervision components that may be critical to implementation with fidelity. Continued research in this area, as well as further demonstrations of successful dissemination and implementation, will be critical for improving the adoption of this intervention in clinical, nonresearch settings.
Implementing contingency management for stimulant use in opioid treatment programs: protocol of a type III hybrid effectiveness-stepped-wedge trial. [2023]Contingency management (CM) is an evidence-based intervention for stimulant use and is highly effective in combination with medication for opioid use disorder. Yet, uptake of CM in opioid treatment programs that provide medication for opioid use disorder remains low. This paradox in which CM is one of the most effective interventions, yet one of the least available, represents one of the greatest research-to-practice gaps in the addiction health services field. Multi-level implementation strategies are needed to address barriers to CM implementation at both the provider- and organization-level. This type III hybrid effectiveness-implementation trial was funded by the National Institute on Drug Abuse to evaluate whether a multi-level implementation strategy, the Science of Service Laboratory (SSL), can effectively promote CM implementation in opioid treatment programs. Specific aims will test the effectiveness of the SSL on implementation outcomes (primary aim) and patient outcomes (secondary aim), as well as test putative mediators of implementation outcomes (exploratory aim).
A systematic review of remotely delivered contingency management treatment for substance use. [2023]Substance use and related consequences (e.g., impaired driving, injuries, disease transmission) continue to be major public health concerns. Contingency management (CM) is a highly effective treatment for substance use disorders. Yet CM remains vastly underutilized, in large part due to implementation barriers to in-person delivery. If feasible and effective, remote delivery of CM may reduce barriers at both the clinic- and patient-level, thus increasing reach and access to effective care. Here, we summarize data from a systematic review of studies reporting remote delivery of CM for substance use treatment.
Implementation of Contingency Management at a Large VA Addiction Treatment Center. [2018]Contingency management (CM) is an evidence-based intervention that reinforces target behaviors of patients, such as abstinence from substance use. This column discusses the experiences and lessons learned at a large U.S. Department of Veterans Affairs Addiction Treatment Center during implementation of CM as part of the VA's national rollout. Challenges are discussed related to staff reception and limited initial referrals, identifying a drug testing method and staff confidence in that method, training requirements, and financial resources needed. Local innovations and CM expansion since 2012 are also reviewed.