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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how using or stopping cannabis affects depression and suicidal thoughts in teenagers. The main focus is on contingency management, a behavioral therapy that encourages teens to stop using cannabis by offering rewards. The study includes participants who use cannabis almost daily and often feel depressed. Participants should have access to a smartphone and be willing to share their progress. As an unphased trial, this study offers a unique opportunity for teens to contribute to important research that could enhance mental health interventions.

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 prior data suggests that this contingency management protocol is safe for adolescents?

A previous study showed that contingency management (CM) helps people reduce or quit using cannabis, especially those with mental health issues like depression. This approach uses rewards to encourage abstinence from cannabis. Research shows it results in more negative drug tests, indicating reduced cannabis use.

Importantly, CM is considered safe and typically does not cause harmful side effects. The reviewed studies did not report significant negative effects linked to this treatment. Overall, CM appears to be a well-tolerated method for reducing cannabis use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Contingency Management protocol for depression and cannabis use because it offers a unique approach to treatment by incentivizing cannabis abstinence. Unlike traditional treatments that might focus on therapy or medication to manage depression, this method uses an escalating remuneration system to encourage participants to stay away from cannabis. This approach not only targets cannabis use directly but also potentially enhances mood by promoting abstinence, which could lead to improved mental health outcomes. The biochemical confirmation of abstinence through decreasing THCCOOH levels adds a reliable measure to this innovative strategy.

What evidence suggests that contingency management for cannabis abstinence could be effective for depression and cannabis use?

Research has shown that contingency management (CM), which participants in this trial may receive, effectively helps people reduce or quit cannabis use. Studies have found that CM leads to more negative drug tests and less cannabis use, particularly in individuals with depression. CM uses rewards to encourage individuals to stop using cannabis and has successfully helped them quit. Evidence also suggests that CM can change how people think and act regarding cannabis use, even after the rewards end. This approach shows promise in helping people cut down or stop cannabis use, potentially improving mental health. ^{1 2 5 6 7}

Who Is on the Research Team?

Randi M Schuster, PhD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

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.

Current daily or near daily cannabis use (≥ 4 days per week on average)

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9855987/

Contingency Management for Treatment of Cannabis Use ... We found CM to be efficacious in producing cannabis use reductions and abstinence amongst individuals with a psychotic-spectrum or major depressive disorder.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11910397/

Effectiveness of cannabis use and cannabis use disorder ... CBT and MET (or combined CBT + MET) treatments that extend beyond four sessions were more effective than fewer sessions over a shorter duration.

3. karger.com karger.com/ear/article/30/5/321/914353/Contingency-Management-for-Cannabis-Use-Disorder

Contingency Management for Cannabis Use Disorder ... Results: Sixteen studies were included, and contingency management intervention likely promotes abstinence outcomes and more negative urinalyses ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0376871624000176

Contingency management is associated with positive ... This study evaluated how short-duration contingency management (CM) impacts cannabis use attitudes and behavior after abstinence incentives are discontinued.

5. mghpsychnews.org mghpsychnews.org/contingency-management-as-harm-reduction-in-youth-using-cannabis/

Contingency Management: An Effective Strategy for Harm ... This study was designed to assess the impact of contingency management (CM) on cannabis use attitudes and behaviors among non-treatment seeking ...

6. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/add.70084

Effectiveness and safety of psychosocial interventions for ... Aim To evaluate the effectiveness, safety and cost-effectiveness of psychosocial interventions for cannabis use disorder (CUD).

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3509418/

Combining cognitive behavioral therapy and contingency ... Combining contingency management and cognitive–behavioural therapy does not appear to improve success rates of treatment for cannabis dependence.