Contingency Management for Depression and Cannabis Use

(CLEAR Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Randi M Schuster, PhD

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Massachusetts General Hospital

Disqualifiers: Epilepsy, Cognitive impairment, others

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

The goal of this study is to disentangle relationships between acute cannabis use and withdrawal on proximal depression and suicide risk and recovery in adolescents ages 12-18 years by incorporating time-varying patterns of substance use, mood, and SI. This project aims to guide the development of scalable, individualized, accessible, and affordable interventions aimed to reduce depression and suicide risk among adolescents.

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 is best to discuss this with the trial coordinators.

What data supports the effectiveness of the treatment Contingency Management for cannabis abstinence?

Research shows that Contingency Management (CM), which uses rewards to encourage positive behavior like staying off cannabis, is effective in helping people reduce cannabis use and achieve abstinence, especially when combined with other therapies like cognitive behavioral therapy. Studies found that CM led to higher abstinence rates in people with cannabis dependence and those with mental health disorders like depression. ^{1 2 3 4 5}

Is contingency management safe for treating cannabis use and depression?

Contingency management (CM) is generally considered safe as it uses positive reinforcement to encourage behavior change, and it has been used effectively in various substance use treatments without significant safety concerns reported. ^{1 2 3 4 6}

How is the treatment 'Contingency Management for Cannabis Abstinence' different from other treatments for depression and cannabis use?

Contingency Management is unique because it uses positive reinforcement, like vouchers for goods or services, to encourage cannabis abstinence, which is different from other therapies that might focus on counseling or medication. This approach has shown success in increasing abstinence rates, especially when combined with other therapies like cognitive-behavioral therapy. ^{1 3 6 7 8}

Research Team

Randi M Schuster, PhD

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

This trial is for adolescents aged 12-18 who experience depression or suicidal thoughts and use cannabis. It aims to understand how cannabis affects their mood and risk of suicide, with the goal of creating better interventions.

Inclusion Criteria

Current or recent (past month) self-injurious thoughts, plan, or attempt (Self-Injurious Thoughts and Behaviors Interview)

I responded to more than 60% of the prompts in the first phase.

Score ≥ 5 on PHQ-9 (telephone screener) or current depressive episode (Mini International Neuropsychiatric Interview Kid 7.0.2)

Exclusion Criteria

Cannabis use >4 times/day on average (to maximize likelihood of capturing mood and self-injurious behavior during non-use times)

I cannot speak or write in English fluently.

Inability to wear Fitbit device (for Fitbit enrollment)

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline

Participants complete a 2-week baseline phase involving real-time, ambulatory smartphone monitoring while using cannabis as usual

2 weeks

1 visit (in-person)

Randomized Treatment

Participants are randomized to either 8 weeks of cannabis abstinence with contingency management or non-contingent monitoring with no abstinence requirement

8 weeks

12 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Contingency management for cannabis abstinence (Behavioral Intervention)

Trial Overview The study tests a strategy called 'contingency management' which rewards individuals for abstaining from cannabis use, to see if it helps reduce depression and suicidal thoughts in youth.

Participant Groups

Group I: Cannabis Abstinence (CB-Abst) Experimental Treatment 1 Intervention

Those randomized to the abstinence condition will be asked to stop using cannabis for eight weeks. They will participate in a contingency management protocol, which uses an escalating remuneration schedule to incentivize abstinence. Abstinence is confirmed biochemically via progressively decreasing values of creatinine-adjusted THCCOOH.

Group II: Cannabis Monitoring (CB-Mon) Active Control 1 Intervention

Those randomized to the monitoring condition will be asked to make no changes to their cannabis use frequency or dose for the duration of the eight week study.

Group III: Pre-intervention Pooled Groups (EMA Phase 1 Only) Active Control 1 Intervention

All enrolled participants will participate in approximately two weeks of EMA data collection prior to being randomized and starting intervention procedures to characterize mood during baseline use as usual (CB-Abst or CB-Mon).

Contingency management for cannabis abstinence is already approved in United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as Contingency Management for:

• Substance Abuse Treatment
• Cannabis Use Disorder

🇪🇺 Approved in European Union as Contingency Management for:

• Substance Abuse Treatment
• Cannabis Use Disorder

🇨🇦 Approved in Canada as Contingency Management for:

• Substance Abuse Treatment
• Cannabis Use Disorder

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Massachusetts General Hopsital Boston, MA

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3066

Patients Recruited

13,430,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2658

Patients Recruited

3,409,000+

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Contingency Management for Treatment of Cannabis Use Disorder in Co-Occurring Mental Health Disorders: A Systematic Review. [2023] Amongst individuals with a mental health disorder, a comorbid diagnosis of cannabis use disorder (CUD) is associated with numerous adverse consequences, including more severe symptom profiles, poorer treatment response, and reduced psychosocial functioning. Contingency management (CM), a method to specifically reinforce target behavior attainment (e.g., substance use abstinence), may provide an effective intervention in treating cannabis use in patients with a dual diagnosis of CUD and a mental health disorder. A systematic search examining the effects of CM on cannabis use, clinical, cognitive, and psychosocial outcomes in patients with a mental health disorder on PubMed, PsycINFO, and EMBASE databases up to November 2022 was performed. Six studies met inclusion criteria for our review. We found CM to be efficacious in producing cannabis use reductions and abstinence amongst individuals with a psychotic-spectrum or major depressive disorder. Additional longitudinal studies with larger sample sizes, other psychiatric populations, and longer follow-up periods are needed to evaluate the sustained effects of CM.

2. England pubmed.ncbi.nlm.nih.gov

Nationwide access to an internet-based contingency management intervention to promote smoking cessation: a randomized controlled trial. [2022] Contingency management (CM) is one of the most effective behavioral interventions to promote drug abstinence, but availability of this treatment is limited. We evaluated the efficacy and acceptability of internet-based CM relative to an internet-based monitoring and goal-setting control group in a nationwide sample of cigarette smokers.

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

Abstinence rates following behavioral treatments for marijuana dependence. [2022] Previous studies have noted particular difficulty in achieving abstinence among those who are marijuana dependent. The present study employed a dismantling design to determine whether adding contingency management (ContM) to motivational enhancement therapy plus cognitive behavioral therapy (MET+CBT), an intervention used in prior studies of treatment for marijuana dependence, would enhance abstinence outcomes. 240 marijuana dependent participants were recruited via advertisements and assigned to either MET+CBT, ContM-only, MET+CBT+ContM, or to a case-management control condition. All interventions involved 9 weekly 1-h sessions, except for the ContM-only condition whose sessions lasted about 15 min. ContM provided reinforcement for marijuana-free urine specimens, in the form of vouchers redeemable for goods or services. Follow-up data were collected at posttreatment and at 3-month intervals for 1 year. The two ContM conditions had superior abstinence outcomes: ContM-only had the highest abstinence rates at posttreatment, and the MET+CBT+ContM combination had the highest rates at later follow-ups. The roles of contingency management and coping skills training in the treatment of marijuana dependence are discussed.

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

Contingency management: utility in the treatment of drug abuse disorders. [2019] Contingency management (CM) is a strategy that uses positive reinforcement to improve the clinical outcomes of substance abusers in treatment, especially sustained abstinence from drugs of abuse. Further, CM has been adopted to improve methodology and interpretation of outcomes in clinical trials testing new pharmacotherapies and to improve adherence to efficacious medications in substance abuse patients. Thus, CM has proven to be widely useful as a direct therapeutic intervention and as a tool in treatment development.

5. England pubmed.ncbi.nlm.nih.gov

Combining cognitive behavioral therapy and contingency management to enhance their effects in treating cannabis dependence: less can be more, more or less. [2021] To evaluate reciprocal enhancement (combining treatments to offset their relative weaknesses) as a strategy to improve cannabis treatment outcomes. Contingency management (CM) with reinforcement for homework completion and session attendance was used as a strategy to enhance cognitive-behavioral therapy (CBT) via greater exposure to skills training; CBT was used as a strategy to enhance durability of CM with rewards for abstinence.

6. Spain pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of contingency management for smoking cessation in substance use treatment patients. [2022] Contingency management (CM) is one of the most effective interventions for smokers with substance use disorder (SUD), and no empirical assessment of its long-term efficacy has been conducted so far in a real-world context. The objectives were: (1) examine the additive effectiveness of CM on cognitive-behavioral treatment (CBT) for smoking cessation, and (2) examine the relationship between smoking cessation and substance use abstinence.

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

Coping skills training and contingency management treatments for marijuana dependence: exploring mechanisms of behavior change. [2021] Achieving abstinence in the treatment of marijuana dependence has been difficult. To date the most successful treatments have included combinations of motivation enhancement treatment (MET) plus cognitive-behavioral coping skills training (CBT) and/or contingency management (ContM) approaches. Although these treatment approaches are theoretically based, their mechanisms of action have not been explored fully. The purpose of the present study was to explore mechanisms of behavior change from a marijuana treatment trial in which CBT and ContM were evaluated separately and in combination.

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

A randomised controlled trial of the clinical and cost-effectiveness of a contingency management intervention compared to treatment as usual for reduction of cannabis use and of relapse in early psychosis (CIRCLE): a study protocol for a randomised controlled trial. [2021] Around 35-45 % of people in contact with services for a first episode of psychosis are using cannabis. Cannabis use is associated with delays in remission, poorer clinical outcomes, significant increases in the risk of relapse, and lower engagement in work or education. While there is a clear need for effective interventions, so far only very limited benefits have been achieved from psychological interventions. Contingency management (CM) is a behavioural intervention in which specified desired behavioural change is reinforced through financial rewards. CM is now recognised to have a substantial evidence base in some contexts and its adoption in the UK is advocated by the National Institute for Health and Care Excellence (NICE) guidance as a treatment for substance or alcohol misuse. However, there is currently little published data testing its effectiveness for reducing cannabis use in early psychosis.