Contingency Management for Stimulant Use Disorder

(MIMIC2 Trial)

Recruiting at 13 trial locations

Overseen By Medical Director of Behavioral Health Chicago Department of Pu

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Northwestern University

Must be taking: Opioid use disorder medications

Disqualifiers: Under 18, No electronic records

Stay on Your Current Meds You can continue your current medications while participating

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

Compensation: Varies

Number of Visits: Unknown

76 Participants Needed

Trial Summary

What is the purpose of this trial?

Stimulants constitute a new and deadly fourth wave of the opioid epidemic. Contingency management is the most effective intervention for stimulant use and is an evidence-based adjunct to medication for opioid use disorder. Yet, uptake of contingency management in opioid treatment programs that provide medication for opioid use disorder remains low; in fact, access to contingency management is arguably one of the greatest research-to-practice gaps in the addiction treatment services field. The goal of this study is to conduct a type III hybrid effectiveness-implementation trial to evaluate a multi-level implementation strategy, the Science of Service Laboratory, to install contingency management for stimulant use in opioid treatment programs. The Science of Service Laboratory has three core components: didactic training, performance feedback, and external facilitation. Utilizing a stepped wedge design, a regional cohort of 10 public sector opioid treatment programs will be randomized to receive Science of Service Laboratory at five distinct time points. At six intervals, each of the 10 opioid treatment programs will provide de-identified electronic medical record data from all available patient charts on contingency management delivery and patient outcomes. Staff from each opioid treatment program will provide feedback on contextual determinants influencing implementation. This study will rigorously evaluate whether a multi-level implementation strategy developed by one of the longest-standing national intermediary purveyor organizations-the SAMHSA Technology Transfer Centers, will improve both implementation and patient outcomes.

Will I have to stop taking my current medications?

The trial protocol does not specify whether participants must stop taking their current medications. It seems to focus on adding contingency management to existing treatments for opioid use disorder.

What data supports the effectiveness of the treatment for stimulant use disorder?

Contingency management (CM) is a treatment that rewards people for positive behavior changes, and it has been shown to be effective for stimulant use disorder. It is considered the best-supported treatment strategy for reducing stimulant use, with evidence of success in both in-person and telehealth settings. ^{1 2 3 4 5}

Is contingency management safe for humans?

Contingency management (CM) has been used in various settings for treating stimulant use disorder, and while specific safety data is limited, it is generally considered safe as it involves behavioral interventions rather than medications. ^{3 6 7 8 9}

How is the treatment 'Contingency Management for Stimulant Use Disorder' different from other treatments?

Contingency Management (CM) is unique because it uses positive reinforcement (rewards) to encourage patients to stay drug-free, which is different from other treatments that may rely on medication or counseling alone. It is particularly effective when combined with medication for opioid use disorder, but its availability is limited despite its proven success. ^{2 3 4 6 10}

Research Team

Sara Becker

Principal Investigator

Northwestern University

Eligibility Criteria

This trial is for adults who are currently receiving medication for opioid use disorders within the last 30 days and also use stimulants, as shown by self-report or positive tests. They must be actively managing patient cases and providing psychosocial support. It's not open to those under 18, unable to consent, or without electronic medical records.

Inclusion Criteria

I am currently managing a group of patients.

I provide counseling support to patients using medication for opioid addiction.

I started medication for opioid addiction in the last 30 days and have used stimulants recently.

Exclusion Criteria

I am under 18 and on medication for opioid use disorder.

I am on medication for opioid use disorder and do not have electronic medical records.

I am under 18 years old.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implementation

Implementation of the Science of Service Laboratory strategy, including didactic training, performance feedback, and facilitation

10 months

Monthly facilitation calls and coaching sessions

Data Collection

Collection of de-identified electronic medical record data and staff feedback at six intervals

10 months

Follow-up

Participants are monitored for safety and effectiveness after implementation

4 weeks

Treatment Details

Interventions

• Science to Service Laboratory

Trial Overview The study is testing a strategy called Science of Service Laboratory designed to help opioid treatment programs implement contingency management for patients with stimulant use disorder. The effectiveness of this multi-level approach will be measured in terms of its adoption by staff and impact on patient outcomes.

Participant Groups

Group I: Science of Service Laboratory implementation strategy Experimental Treatment 1 Intervention

The Science of Service Laboratory implementation strategy consists of: didactic training (contingency management workshops; monthly contingency management coaching calls), performance feedback (practice sessions and electronic medical record feedback); and facilitation (monthly facilitation calls).

Group II: Stepped wedge comparator Active Control 1 Intervention

Our hybrid trial uses a unidirectional crossover stepped wedge design. All sites cross over in the same direction from usual care to intervention. All sites therefore act as their own comparison prior to the sequential roll-out of the implementation strategy.

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Stanford University

Collaborator

Trials

2,527

Recruited

17,430,000+

Ohio State University

Collaborator

Trials

891

Recruited

2,659,000+

Findings from Research

Telehealth-based contingency management (CM) for stimulant use disorder has shown preliminary feasibility and acceptability, allowing participants to successfully engage in treatment and verify abstinence through self-administered oral fluid testing.

Improvements are needed in the remote interpretation of toxicology test results to ensure accurate detection of abstinence, which is critical for delivering therapeutic incentives effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telehealth-Based Contingency Management Targeting Stimulant Abstinence: A Case Series from the COVID-19 Pandemic. Forster, SE., Torres, TM., Steinhauer, SR., et al.[2023]

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]

Contingency management programs, which reward behavior change to reduce stimulant use, are currently the most effective treatment for stimulant use disorder, but they are often hard to access.

A case study of a patient with osteomyelitis showed that adapting these programs to an inpatient hospital setting can significantly improve treatment outcomes for individuals with stimulant use disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Acute Care Contingency Management Program for the Treatment of Stimulant Use Disorder: A Case Report. Bach, P., Garrod, E., Robinson, K., et al.[2022]

A new standardized strategy for reporting adverse events (AEs) and serious adverse events (SAEs) in substance use disorder (SUD) clinical trials was developed, which aims to reduce the reporting burden while maintaining safety monitoring.

In a review of 17 SUD trials involving 6737 participants, the new strategy showed a significant reduction in irrelevant safety event reporting, leading to a more consistent safety assessment system tailored to the risks associated with specific trial interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Strategies for safety reporting in substance abuse trials. Lindblad, R., Campanella, M., Styers, D., et al.[2013]

Contingency management (CM) is an effective treatment for stimulant use disorders, and this guide provides a structured protocol to enhance its implementation in clinical settings.

The article emphasizes the importance of adhering to evidence-based practices in CM, as poorly designed programs are unlikely to improve patient outcomes, highlighting the need for careful planning and preparation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing an evidence-based prize contingency management protocol for stimulant use. Rash, CJ.[2023]

References

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

Telehealth-Based Contingency Management Targeting Stimulant Abstinence: A Case Series from the COVID-19 Pandemic. [2023]

2. 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]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Adapting Contingency Management for Hospitalized Patients with Stimulant Use Disorder. [2023]

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

Contingency Management for Stimulant Use Disorder: Progress, Challenges, and Recommendations. [2023]

5. Netherlands pubmed.ncbi.nlm.nih.gov

An Acute Care Contingency Management Program for the Treatment of Stimulant Use Disorder: A Case Report. [2022]

6. Netherlands pubmed.ncbi.nlm.nih.gov

A Mixed-methods Evaluation of an Addiction/Cardiology Pilot Clinic With Contingency Management for Patients With Stimulant-associated Cardiomyopathy. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Epidemiology of stimulant misuse and abuse: implications for future epidemiologic and neuropharmacologic research. [2014]

8. England pubmed.ncbi.nlm.nih.gov

Treatment outcomes of stimulant misusers: one year follow-up results from the national treatment outcome research study (NTORS). [2016]

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

Strategies for safety reporting in substance abuse trials. [2013]

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

Implementing an evidence-based prize contingency management protocol for stimulant use. [2023]