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

100 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will test whether 42 days of cannabis abstinence, compared to continued cannabis use, is associated with improvements in cognition and psychiatric disorder symptoms. Identical twins, who are concordant on cannabis use, will be experimentally-manipulated to be discordant for 42 days. Each twin, within a twin pair, will be randomly assigned to either the contingency management condition, incentive-based protocol to promote cannabis abstinence, or control condition, no changes in cannabis use requested.

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 data supports the effectiveness of the treatment Contingency Management for improving cognition and mental health in cannabis users?

Research shows that Contingency Management (CM) is effective in reducing cannabis use and achieving abstinence, especially in individuals with mental health disorders like psychotic-spectrum or major depressive disorder. CM has also been found to improve outcomes when combined with other therapies for marijuana dependence, suggesting it can help improve mental health and cognitive outcomes by promoting cannabis abstinence. ^{1 2 3 4 5}

Is contingency management safe for humans?

Contingency management (CM) is generally considered safe for humans and is recognized as an effective behavioral intervention for promoting drug abstinence, including cannabis and stimulant use. It involves reinforcing desired behaviors, like abstinence, with rewards, and has been supported by organizations like the National Institute for Health and Care Excellence (NICE) for substance misuse treatment. ^{1 2 3 5 6}

How does contingency management treatment differ from other treatments for cannabis use disorder?

Contingency management is unique because it uses positive reinforcement, like vouchers for goods or services, to encourage cannabis abstinence, which can be more effective than traditional therapies alone. This approach specifically rewards individuals for achieving and maintaining drug-free status, making it distinct from other treatments that may not include such direct incentives. ^{1 4 5 7 8}

Research Team

J. Megan Ross, Ph.D.

Principal Investigator

University of Colorado, Denver

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

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]

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]

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]

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 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]

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

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]

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

Behavioral therapies for treatment-seeking cannabis users: a meta-analysis of randomized controlled trials. [2022]

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

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

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

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

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

Reduction in Cannabis Use and Functional Status in Physical Health, Mental Health, and Cognition. [2019]

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

A randomized trial adapting contingency management targets based on initial abstinence status of cocaine-dependent patients. [2021]