Contingency Management for Depression and Cannabis Use

(CLEAR Trial)

Overseen By Randi M Schuster, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Epilepsy, Cognitive impairment, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 13

200 Participants Needed

Trial Summary

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}

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.

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)

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

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

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Findings from Research

Contingency management (CM) has been shown to effectively reduce cannabis use and promote abstinence in individuals with comorbid cannabis use disorder and mental health disorders, particularly those with psychotic-spectrum or major depressive disorders.

The review included six studies, indicating a need for more extensive longitudinal research with larger sample sizes and diverse psychiatric populations to better understand the long-term effects of CM.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contingency Management for Treatment of Cannabis Use Disorder in Co-Occurring Mental Health Disorders: A Systematic Review. Rodas, JD., Sorkhou, M., George, TP.[2023]

In a study of 94 smokers, an internet-based contingency management program that provided financial incentives for verified abstinence significantly increased short-term smoking cessation rates at 4 weeks (39.6% abstinence) compared to a control group (13.0% abstinence).

While the initial benefits of the incentive program diminished over time, with no significant differences at 3 and 6 months, the program was well-received, particularly for its ease of use and the financial rewards, indicating its potential as an effective tool for promoting smoking cessation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nationwide access to an internet-based contingency management intervention to promote smoking cessation: a randomized controlled trial. Dallery, J., Raiff, BR., Kim, SJ., et al.[2022]

In a study involving 240 marijuana-dependent participants, adding contingency management (ContM) to motivational enhancement therapy plus cognitive behavioral therapy (MET+CBT) significantly improved abstinence rates compared to other treatment conditions.

The ContM-only group achieved the highest abstinence rates immediately after treatment, while the combination of MET+CBT and ContM showed the best outcomes at follow-up, highlighting the effectiveness of reinforcement strategies in treating marijuana dependence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Abstinence rates following behavioral treatments for marijuana dependence. Kadden, RM., Litt, MD., Kabela-Cormier, E., et al.[2022]

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]

In a 12-week clinical trial with 127 young adults seeking treatment for cannabis dependence, combining contingency management (CM) with cognitive-behavioral therapy (CBT) did not improve treatment outcomes and actually worsened results when compared to CM alone.

The CM for abstinence condition was the most effective, showing the highest percentage of cannabis-free urine specimens, while the enhanced treatment groups experienced increased cannabis use during a 1-year follow-up, indicating that combining these therapies may not be beneficial.

NCBI (Pubmed)

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. Carroll, KM., Nich, C., Lapaglia, DM., et al.[2021]

Contingency management (CM) significantly improved tobacco abstinence rates when added to cognitive-behavioral treatment (CBT) for smoking cessation in a study of 80 participants, indicating its effectiveness in the short term.

However, the benefits of CM diminished after treatment ended, and quitting smoking did not negatively impact abstinence from other substances, suggesting that smoking cessation does not jeopardize recovery from substance use disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of contingency management for smoking cessation in substance use treatment patients. Secades-Villa, R., Aonso-Diego, G., González-Roz, A.[2022]

In a study involving 240 adult marijuana smokers, the most effective treatments for achieving long-term abstinence from marijuana were those that enhanced self-efficacy and coping skills, regardless of the specific treatment approach used.

The research highlighted that while short-term abstinence was primarily linked to abstinence during treatment, long-term success was more strongly associated with the ability to use coping skills and confidence in maintaining abstinence after treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Coping skills training and contingency management treatments for marijuana dependence: exploring mechanisms of behavior change. Litt, MD., Kadden, RM., Kabela-Cormier, E., et al.[2021]

The CIRCLE trial is a randomized controlled trial involving 544 young people with early psychosis and recent cannabis use, testing the effectiveness of contingency management (CM) to reduce cannabis use and improve clinical outcomes.

Participants in the experimental group will receive 12 weekly sessions of CM, which includes financial rewards for cannabis-free urine tests, alongside standard psychoeducational treatment, aiming to assess its impact on relapse rates and overall engagement in work or education.

NCBI (Pubmed)

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. Johnson, S., Sheridan Rains, L., Marwaha, S., et al.[2021]

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]

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]

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

Abstinence rates following behavioral treatments for marijuana dependence. [2022]

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

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

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]

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

A randomized controlled trial of contingency management for smoking cessation in substance use treatment patients. [2022]

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

Coping skills training and contingency management treatments for marijuana dependence: exploring mechanisms of behavior change. [2021]

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]