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

Trial Summary

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.

Is Contingency Management safe for humans?

Contingency Management (CM) has been used safely in various settings, particularly for treating substance use disorders. It involves providing incentives to encourage positive behaviors, and there are no reports of harmful effects from its use in the studies reviewed. ^{1 2 3 4 5}

How is the treatment Contingency Management (CM) unique for PTSD?

Contingency Management (CM) is unique because it uses tangible rewards to encourage positive behavior changes, which is different from traditional PTSD treatments that often focus on talk therapy or medication. This approach is based on behavioral principles and has been effective in treating substance use disorders, suggesting it may offer a novel way to support behavior change in PTSD patients. ^{1 6 7 8 9}

What is the purpose of this trial?

Posttraumatic stress disorder (PTSD) is a disabling psychiatric disorder that affects 20%-30% of U.S. Veterans. PTSD is strongly associated with increased risk for substance abuse comorbidity, including cannabis use disorder. Multiple states now include PTSD as a condition for which patients can be legally prescribed medical marijuana, despite the fact that there has not been a single large-scale randomized clinical trial demonstrating the efficacy of cannabis to treat PTSD to date. The overall objective of the current proposal is to study the impact of reduced cannabis use on functioning among Veterans with PTSD. The investigators will evaluate the relationship between cannabis use and daily functioning among cannabis users and heavy cannabis users. The central hypothesis is that reductions in cannabis use will lead to positive changes in the functional outcomes of Veterans. The rationale for this research is that it will provide the first and only real-time data concerning the impact of reduced cannabis use on daily functioning among Veterans with PTSD.

Research Team

Jean C Beckham, PhD

Principal Investigator

Durham VA Medical Center, Durham, NC

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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) 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) 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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Improving substance misuse outcomes in contingency management treatment with adjunctive formal psychotherapy: a systematic review and meta-analysis. [2021]

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

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

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

An effectiveness trial of contingency management in a felony preadjudication drug court. [2021]

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

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

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

Contingency management: utility in the treatment of drug abuse disorders. [2019]

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

A randomized trial of contingency management delivered by community therapists. [2023]

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

Budget Impact Tool for Implementing Contingency Management for Co-occurring Alcohol Use Disorders and Serious Mental Illness. [2023]

8. Germany pubmed.ncbi.nlm.nih.gov

Motivation and Contingency Management Treatments for Substance Use Disorders. [2016]

9. Ireland pubmed.ncbi.nlm.nih.gov

A randomized study of contingency management in cocaine-dependent patients with severe and persistent mental health disorders. [2021]