Cannabis Abstinence for Improved Cognition and Mental Health

Overseen By J. Megan Ross, Ph.D.

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Disqualifiers: Traumatic brain injury, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 42 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether stopping cannabis use for 42 days can improve thinking skills and mental health symptoms. Identical twins participate, with one twin stopping cannabis use with support through contingency management (a behavioral reinforcement strategy), while the other continues as usual. The trial targets twins who both use cannabis at least once a week and reside in Colorado.

As an unphased study, this trial provides a unique opportunity to contribute to understanding the impact of cannabis cessation on mental health.

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 focuses on cannabis use, so it's best to ask the trial coordinators for more details.

What prior data suggests that this protocol is safe for participants?

Research has shown that contingency management is generally well-tolerated. In one study, 34 out of 38 participants stayed off cannabis for 30 days using this method. Another study found that 81.7% of participants avoided cannabis for four weeks with the help of contingency management. These studies indicate that people handle this treatment well. Reports have not identified major side effects or safety issues, suggesting it is a safe way to help people stop using cannabis. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about contingency management for cannabis abstinence because it offers a unique, incentive-based approach. Unlike typical treatments such as cognitive behavioral therapy or pharmacotherapy, which focus on changing thought patterns or managing symptoms with medication, contingency management directly rewards individuals for staying drug-free. This method leverages tangible incentives, like cash payments, to reinforce positive behavior, potentially leading to improved cognition and mental health outcomes. By providing immediate and increasing rewards, it encourages sustained abstinence, which could result in longer-lasting benefits compared to traditional methods.

What evidence suggests that contingency management is effective for improving cognition and mental health?

Research has shown that contingency management (CM), which participants in this trial may receive, effectively helps people reduce or stop using cannabis. In one study, 81.7% of participants stayed off cannabis for four weeks with CM. This method uses rewards to encourage positive behaviors like staying drug-free. A review of 16 studies confirmed that CM can increase the chances of staying off drugs and lead to more negative drug tests. CM remains effective even for those who use other substances, highlighting its strong potential to help people quit cannabis. ^{1 2 3 4 6}

Who Is on the Research Team?

J. Megan Ross, Ph.D.

Principal Investigator

University of Colorado, Denver

Are You a Good Fit for This Trial?

This trial is for identical twins in Colorado who both use cannabis at least once a week and have done so recently. Both must agree to participate, with similar levels of use (+/- 2 days). They should test positive for THC in urine at the start.

Inclusion Criteria

Cannabis use at least 1x per week on most weeks

Located within the state of Colorado

Positive qualitative urine toxicology at baseline for THC

Exclusion Criteria

My twin and I had different experiences; I had a traumatic brain injury.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo baseline assessments for cognition and psychiatric symptoms

1 week

1 visit (in-person)

Treatment

Participants are assigned to either cannabis abstinence with contingency management or control condition

42 days

Multiple visits for drug testing and assessments

Follow-up

Participants are monitored for changes in cognition and psychiatric symptoms after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Contingency management

Trial Overview The study tests if not using cannabis for 42 days improves thinking skills and mental health symptoms compared to continued use. Twins will be randomly assigned to either stop using cannabis, with incentives (contingency management), or keep their usual habits.

How Is the Trial Designed?

Group I: Contingency management Experimental Treatment 1 Intervention

Contingency management (CM) is an incentive-based intervention providing patients with tangible rewards as reinforcement for positive behaviors like abstinence from drug use. Incentives are provided with each urine sample that is drug-free and are increased with each subsequent drug-free urine sample. Participants in the CM condition will receive increasing payments for abstinence: $30 on day 3, $45 on day 5, $60 on day 7, $75 on day 14, $90 on day 21, $105 on day 28, and $120 on day 42. Participants in both conditions also receive increasing payment for visit attendance: $10 on day 1, $15 on day 3, $20 on day 5, $25 on day 7, $30 on day 14, $35 on day 21, $45 on day 28, and $55 on day 42. At the end of the baseline visit, participants in the CM condition will sign a behavioral contract with study staff that clearly outlines expectations as well as the payment schedule.

Group II: No intervention Active Control 1 Intervention

Participants in this condition will be monitored and will not receive any compensation for cannabis abstinence.

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

Approved in United States as Contingency Management for:

• Alcohol dependence
• Substance use disorders

Approved in European Union as Contingency Management for:

• Alcohol dependence
• Substance use disorders

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

University of Colorado, Boulder

Collaborator

Trials

128

Recruited

29,600+

Published Research Related to This Trial

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 333 cocaine-negative patients, both attendance-based and abstinence-based contingency management (CM) were equally effective in enhancing the longest duration of abstinence, with attendance-based CM leading to higher participation and submission of negative samples.

For 109 cocaine-positive patients, a higher magnitude abstinence-based CM ($560Abs) significantly improved abstinence outcomes compared to standard care, indicating that greater rewards can enhance treatment effectiveness for those actively using cocaine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized trial adapting contingency management targets based on initial abstinence status of cocaine-dependent patients. Petry, NM., Barry, D., Alessi, SM., et al.[2021]

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]

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]

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]

A meta-analysis of 10 randomized controlled trials involving 2,027 participants found that behavioral therapies (BTs) significantly improve outcomes for cannabis use disorders compared to control conditions, with an effect size of 0.44, indicating that patients receiving BTs fared better than 66% of those in control groups.

Behavioral therapies were effective in reducing both the frequency and severity of cannabis use, as well as improving psychosocial functioning, with larger effect sizes observed in studies using waitlist controls compared to those with active control comparisons.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral therapies for treatment-seeking cannabis users: a meta-analysis of randomized controlled trials. Davis, ML., Powers, MB., Handelsman, P., 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]

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/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.

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

Contingency Management: An Effective Strategy for Harm ... Of participants randomized to the CM intervention (n=126), 81.7% (n=103) had 4 weeks of biochemically-verified continuous cannabis abstinence.

5. 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 equally effective among those with concurrent stimulant and opioid use disorder, as well as in promoting abstinence from cannabis use (SAMHSA, 2021a).

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

Effectiveness and safety of psychosocial interventions for ... The effect of community reinforcement on point abstinence was OR = 0.29 (0.04−1.90) versus MET-CBT, and on continuous abstinence OR = 47.36 ( ...