Contingency Management for PTSD

(FOCUS Trial)

Overseen By Angela C Kirby, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Bipolar, Schizophrenia, Imprisonment, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how reducing cannabis use affects daily life for Veterans with PTSD (posttraumatic stress disorder). Researchers are testing a treatment called Contingency Management (CM), which rewards participants for reducing cannabis use. Veterans with PTSD who frequently use cannabis (at least 13 days in the last month) might be suitable for this study. The goal is to determine if using less cannabis can improve overall functioning.

As an unphased trial, this study offers Veterans a unique opportunity to contribute to understanding how reducing cannabis use can enhance daily life and well-being.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you've had a change in your psychiatric medication regimen in the past month or expect a change during the study.

What prior data suggests that Contingency Management is safe for reducing cannabis use in Veterans with PTSD?

Research has shown that contingency management (CM) effectively helps people reduce substance use. In several studies, CM has helped individuals avoid drugs by rewarding them for staying drug-free. This method has proven successful for various substance use problems.

CM has also been tested with individuals who have PTSD (posttraumatic stress disorder). One study found that CM was effective for those trying to quit smoking, even among individuals with a history of trauma. Another study demonstrated that CM helped reduce cocaine use in people with PTSD.

These studies suggest that CM is generally well-received, with no major reports of negative effects from CM itself. Instead, it fosters a supportive environment that encourages positive change through rewards.

Overall, CM is considered a safe and effective way to reduce drug use, making it a promising option for individuals with PTSD and substance use challenges. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for PTSD involve medications or talk therapies like cognitive behavioral therapy. However, Contingency Management (CM) is unique because it uses a behavioral approach to encourage positive change. This method involves providing incentives to veterans with PTSD to reduce their cannabis use, which can be particularly appealing for those looking to avoid medication. Researchers are excited because CM is a mobile, flexible solution that actively rewards participants, potentially leading to more sustainable reductions in substance use while simultaneously addressing PTSD symptoms.

What evidence suggests that Contingency Management is effective for reducing cannabis use in Veterans with PTSD?

Research has shown that Contingency Management (CM), which participants in this trial will receive, effectively treats substance use disorders. This treatment uses rewards to motivate individuals to reduce substance use. Studies have found that CM can help reduce drug use, including cannabis. While CM is often used for opioid addiction, it has also shown promise for other substance use problems. Although large-scale studies specifically on CM for PTSD and cannabis use are lacking, its success with other addictions suggests it could help Veterans reduce cannabis use and improve their daily lives. ^{2 6 7 8 9}

Who Is on the Research Team?

Jean C Beckham, PhD

Principal Investigator

Durham VA Medical Center, Durham, NC

Are You a Good Fit for This Trial?

This trial is for U.S. Veterans with PTSD who frequently use cannabis (13+ days in the past month) and can communicate in English. It's not open to those who've changed psychiatric meds recently, are getting non-study treatment for Cannabis Use Disorder, have been hospitalized or imprisoned, or have bipolar disorder, schizophrenia, or a substance use disorder other than cannabis.

Inclusion Criteria

I have been diagnosed with PTSD.

Veteran status

Ability to speak and write fluent English

Exclusion Criteria

I have been hospitalized for mental health reasons.

Become imprisoned

Are receiving non-study CUD treatment

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo mobile contingency management (CM) to promote reductions in cannabis use

6 weeks

Baseline and post-treatment assessments

Follow-up

Participants are monitored for changes in quality of life, functional impairment, cannabis use, and psychiatric distress

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Contingency Management (CM)

Trial Overview The FOCUS trial investigates whether reducing cannabis use improves daily functioning in Veterans with PTSD. The study uses Contingency Management (CM), which rewards individuals for meeting goals like reduced substance use.

How Is the Trial Designed?

Group I: Contingency Management (CM) Experimental Treatment 1 Intervention

Mobile contingency management (CM) will be used to promote reductions in cannabis use among Veterans with PTSD who are heavy cannabis users. CM is an intensive behavioral therapy in which participants are paid to reduce substance use.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

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]

Contingency management (CM) significantly improved patient outcomes in a study involving 130 patients treated by trained clinicians, with those receiving CM staying in treatment longer (9.5 weeks vs. 6.7 weeks) and achieving greater durations of abstinence (4.7 weeks vs. 1.7 weeks).

Patients in the CM group submitted a higher proportion of negative drug samples (57.7%) compared to those receiving standard care (29.4%), highlighting the efficacy of CM in promoting abstinence in a community-based methadone maintenance setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized trial of contingency management delivered by community therapists. Petry, NM., Alessi, SM., Ledgerwood, DM.[2023]

Contingency management (CM) is an effective psychosocial treatment for substance use disorders that uses tangible rewards to reinforce drug-negative behaviors, showing strong efficacy based on behavioral analysis principles.

CM not only provides external rewards but may also enhance a patient's intrinsic motivation to change their substance use behavior, suggesting broader applications for this intervention beyond substance use disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Motivation and Contingency Management Treatments for Substance Use Disorders. Walter, KN., Petry, NM.[2016]

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]

The study assessed a contingency management program in a drug court, where participants could earn up to $390 in gift certificates for compliance, but no overall effectiveness of the program was found, likely due to existing intensive interventions and low reinforcement density.

However, participants with more serious criminal backgrounds showed potential benefits from the contingency management approach, indicating that such programs may be more effective for individuals with more severe drug-related issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An effectiveness trial of contingency management in a felony preadjudication drug court. Marlowe, DB., Festinger, DS., Dugosh, KL., et al.[2021]

Contingency management (CM) effectively uses positive reinforcement to enhance treatment outcomes for substance abusers, particularly in achieving sustained abstinence from drugs.

CM is not only beneficial as a direct therapeutic approach but also serves as a valuable tool in clinical trials for testing new medications and improving patient adherence to treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contingency management: utility in the treatment of drug abuse disorders. Stitzer, ML., Vandrey, R.[2019]

The cost to set up a contingency management (CM) program for treating patients with severe alcohol use disorder and serious mental illness is approximately $6,038 per site, with average treatment costs ranging from $1,119 to $1,865 per participant over 16 weeks depending on the CM version used.

This study provides a customizable costing tool that helps treatment providers estimate expenses associated with different CM designs, which can aid in budgeting and sustaining CM interventions in their practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Budget Impact Tool for Implementing Contingency Management for Co-occurring Alcohol Use Disorders and Serious Mental Illness. Lu, TT., Parent, SC., Chaytor, N., et al.[2023]

In a study involving 19 cocaine-dependent patients with severe mental health issues, those receiving contingency management (CM) achieved significantly longer periods of cocaine abstinence (2.9 weeks) compared to those who only underwent urine testing (0.6 weeks), indicating CM's effectiveness in this population.

Patients in the CM group also experienced reductions in psychiatric symptoms over time, suggesting that CM not only helps with substance use but may also improve mental health outcomes, warranting further research in larger studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized study of contingency management in cocaine-dependent patients with severe and persistent mental health disorders. Petry, NM., Alessi, SM., Rash, CJ.[2021]

A systematic review of 12 randomized controlled trials involving 1654 adults found that adding cognitive-behavioral therapy (CBT) or motivational enhancement therapy (MET) to contingency management (CM) did not improve rates of abstinence from substance use at the end of treatment or during follow-up.

The analysis showed no significant benefits in secondary outcomes, such as self-reported days of substance use, indicating that CM alone is as effective as when combined with these psychotherapeutic interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving substance misuse outcomes in contingency management treatment with adjunctive formal psychotherapy: a systematic review and meta-analysis. Sheridan Rains, L., Steare, T., Mason, O., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6324961/

Contingency management and cognitive behavioral therapy ... The efficacy of CM + CBT without pharmacological support for smoking cessation in PTSD remains unknown. Herein we report the results of a one-month pilot study ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5154900/

Contingency management: New directions and remaining ... Contingency management (CM) is a behavioral intervention that has been especially useful and effective in the treatment of substance use disorders (SUD).

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0091743523001743

lessons learned implementing contingency management in ... Highlights · Contingency management (CM) is effective yet underused in opioid treatment programs · Implementation of CM requires multi-level, ongoing strategies.

4. frontiersin.org frontiersin.org/journals/public-health/articles/10.3389/fpubh.2024.1229262/full

The effectiveness of the community reinforcement ... The present study investigated the effectiveness of the Community Reinforcement Approach (CRA) in the context of quality of life among drug addicts.

5. jsatjournal.com jsatjournal.com/article/S2949-8759(23)00027-9/abstract

A systematic review of remotely delivered contingency ... Contingency management (CM) is a highly effective treatment for substance use disorders. ... A meta-analysis of voucher-based reinforcement ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3472706/

Effect of PTSD diagnosis and contingency management ... This randomized clinical trial retrospectively examined the effect of Post Traumatic Stress Disorder (PTSD) and contingency management (CM) on cocaine use ...

7. psychiatrictimes.com psychiatrictimes.com/view/contingency-management-is-a-powerful-clinical-tool-for-treating-substance-use-research-evidence-and-new-practice-guidelines-for-use

Contingency Management Is a Powerful Clinical Tool for ... CM is one of the most effective behavioral interventions for initiating and maintaining abstinence from most types of commonly used drugs and ...

8. library.samhsa.gov library.samhsa.gov/sites/default/files/contingency-management-advisory-pep24-06-001.pdf

contingency-management-advisory-pep24-06-001.pdf CM is widely studied and has been successful in treating a variety of SUDs in diverse populations, and with demonstrated long-term benefit (a median of 24 weeks ...

9. researchgate.net researchgate.net/publication/328599387_Contingency_management_and_cognitive_behavioral_therapy_for_trauma-exposed_smokers_with_and_without_posttraumatic_stress_disorder

Contingency management and cognitive behavioral ... This pilot study examined the feasibility of CM plus brief cognitive behavioral therapy (CBT) in promoting smoking cessation among trauma-exposed individuals ...