Cannabis Abstinence for Cannabis Use Disorder

Overseen By Venessa Fuentes

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Minnesota

Must not be taking: Antipsychotics, Unstable psychotropics

Disqualifiers: Substance use disorders, Nicotine, Psychosis, others

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

Compensation: Varies

Number of Visits: 8

Duration: 6 weeks

64 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how the brains of teenagers with and without Cannabis Use Disorder (CUD) respond differently, particularly during Cannabis Abstinence (CB-Abst). Researchers will use brain scans to observe changes in brain activity related to rewards and impulsivity. The trial includes two groups: one where teens with CUD attempt to abstain from cannabis with incentives, and another where they maintain their usual habits without required abstinence. Teens aged 15-18 who have used cannabis frequently in the past two months or have never used it might be suitable candidates. Participants must attend several study visits, including some with brain scans. As an unphased trial, this study provides a unique opportunity to contribute to understanding adolescent brain development and the effects of cannabis use.

Will I have to stop taking my current medications?

If you are taking psychotropic medications, you can continue them as long as they have been stable for 6 weeks and are expected to remain stable throughout the study.

What prior data suggests that this study's protocol is safe for adolescents?

Previous studies have shown that the types of support used in this trial for cannabis use disorder (CUD) are quite safe. These methods typically avoid medication, resulting in fewer physical side effects compared to drug-based treatments. For instance, the treatments often include counseling or programs that reward positive behavior changes.

Although this study does not involve new drugs, it is important to recognize that cannabis use can sometimes lead to problems. Research indicates that people with CUD might face issues such as relationship troubles and lower success in school or work. This study, however, focuses on helping individuals either stop using cannabis or use it more safely, which can reduce these risks.

Overall, the methods used in this study, such as offering rewards for not using cannabis, have been well-tolerated and effective in past research for managing CUD. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the CB-Abst and CB-Mon protocols for cannabis use disorder (CUD) because they offer a fresh approach compared to traditional treatments like behavioral therapies and support groups. Unlike conventional methods, which often focus on gradual reduction or management of usage, CB-Abst and CB-Mon specifically aim to achieve complete cannabis abstinence in adolescents. This targeted approach could provide clearer insights into the behavioral and biological effects of total cessation, potentially leading to more effective strategies for long-term recovery in younger populations. By understanding the distinct impacts of these methods, researchers hope to pave the way for tailored interventions that address the unique challenges faced by adolescents with CUD.

What evidence suggests that this trial's treatments could be effective for Cannabis Use Disorder?

Research has shown that certain treatments, such as contingency management, can help individuals with Cannabis Use Disorder (CUD) stop using cannabis. Contingency management involves providing rewards to encourage cannabis-free behavior, and this approach increases the chances of quitting. In this trial, participants in the CB-Abst arm will focus on abstaining from cannabis use. Studies indicate that these methods can lead to fewer days of cannabis use and help individuals maintain their progress. Meanwhile, participants in the CB-Mon arm will focus on monitoring their cannabis use, which is crucial for understanding and managing their consumption. Overall, both treatment options in this trial aim to help individuals reduce cannabis use and understand its effects on their brains and behavior. ^{2 3 4 6 7}

Who Is on the Research Team?

Brenden Tervo-Clemmens, PhD

Principal Investigator

University of Minnesota

Are You a Good Fit for This Trial?

Adolescents aged 15-18 with Cannabis Use Disorder (CUD) who use cannabis at least 5 days a week and those without any history of cannabis use. Participants must be native English speakers, have stable psychotropic medication if applicable, and commit to 8 study visits over about two months. They cannot have other substance abuse disorders, daily nicotine use, MRI contraindications like metal implants or claustrophobia, or serious medical/psychiatric conditions.

Inclusion Criteria

You have never used cannabis before, and your urine test shows no signs of recent cannabis use. You do not plan to start using cannabis during the study.

A parent or legal guardian can give permission for you to be in the study by signing a form.

I am a native English speaker.

Exclusion Criteria

I haven't had a substance use disorder, except for cannabis, in the past year.

Contraindications for MRI (ascertained via participant and parent report), including but not limited to: metal implants such as surgical clips or pacemakers, or history of working with metal, unless the possibility of a metal fragment can be ruled out by recent orbital scans; prior head trauma with neurological sequelae; claustrophobia; weight incompatible with MRI safety; pregnancy; previous or current diagnosis of psychosis, cognitive disability, or bipolar disorder; active suicidality; taking a psychotropic medication that has not reached stability criterion (same medication type and dose for 6 weeks with no planned changes over the study period); any other medical or psychiatric condition deemed serious or contraindicated for any study procedures by Dr. Tervo-Clemmens

Current daily nicotine use (e.g., via electronic and/or combustible cigarettes)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo 6 weeks of either incentivized, biochemically verified abstinence or monitoring with no required abstinence, with fMRI data collection at baseline, week 3, and week 6

6 weeks

8 visits (3 with fMRI scans)

Follow-up

Participants are monitored for changes in neural correlates of reward and self-reported impulsivity

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• CB-Abst
• CB-Mon

Trial Overview The trial is testing the effects of a six-week period where adolescents with CUD either abstain from cannabis use under supervision (CB-Abst group) or continue their usual consumption without abstinence requirements (CB-Mon group). The control group has no history of cannabis use. Brain function will be measured using fMRI scans during tasks related to reward processing and impulsivity.

How Is the Trial Designed?

Group I: CB-MON Experimental Treatment 1 Intervention

adolescents ages 15-18 years old with CUD use randomized to CB-Mon

Group II: CB-Abst Experimental Treatment 1 Intervention

adolescents ages 15-18 years old with CUD use randomized to CB-Abst

Group III: control Active Control 1 Intervention

Age- and sex-matched adolescents with no lifetime history of cannabis use will also complete the protocol.

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

Published Research Related to This Trial

Marijuana dependence is characterized by three key elements: preoccupation with obtaining marijuana, compulsive use, and relapse, which are essential for diagnosing addiction.

The consequences of marijuana addiction can lead to various medical, psychiatric, and social issues, and these effects are driven by the drug's reinforcing properties rather than external stressors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The diagnosis of marijuana (cannabis) dependence. Miller, NS., Gold, MS.[2019]

A study involving 186 adults with problematic cannabis use found that a self-directed treatment workbook combined with a single motivational interviewing session significantly reduced cannabis use frequency and increased abstinence rates at the 3-month follow-up compared to a workbook alone or a delayed treatment control.

The results suggest that this low-intensity intervention can effectively support individuals seeking recovery with minimal professional help, addressing a gap in treatment options for cannabis use disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Promoting self-change in cannabis use disorder: Findings from a randomized trial. Schluter, MG., Hodgins, DC., Stea, JN., et al.[2022]

In a 12-week clinical trial involving 225 adults with cannabis use disorder, reductions in cannabis use frequency and quantity were linked to significant improvements in depression, anxiety, and cannabis-related problems.

The study suggests that measuring changes in cannabis use risk levels can serve as a meaningful endpoint for assessing the efficacy of treatments for cannabis use disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating cannabis use risk reduction as an alternative clinical outcome for cannabis use disorder. Sherman, BJ., Sofis, MJ., Borodovsky, JT., et al.[2023]

Reducing the number of days individuals use cannabis is linked to improvements in their overall functioning, suggesting that this could be a valuable outcome measure in treatment trials for cannabis use disorder (CUD).

While reductions in the amount of cannabis used showed inconsistent links to functional improvements, biologically-confirmed reductions in usage frequency may serve as a reliable endpoint for future clinical trials, highlighting the need for further research on quantifying cannabis reduction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Measuring Within-Individual Cannabis Reduction in Clinical Trials: A Review of the Methodological Challenges. Tomko, RL., Gray, KM., Huestis, MA., et al.[2022]

The pilot study involved four male veterans with cannabis use disorder and sleep problems, testing a mobile app for Cognitive Behavioral Therapy for Insomnia (CBT-I) over two weeks.

Participants using the CBT-I app reported daily use, found it helpful, and experienced decreased cannabis use and improved sleep efficiency, suggesting that mobile CBT-I could be a promising intervention for cannabis dependence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile App-Delivered Cognitive Behavioral Therapy for Insomnia: Feasibility and Initial Efficacy Among Veterans With Cannabis Use Disorders. Babson, KA., Ramo, DE., Baldini, L., et al.[2020]

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 206 cannabis users and 999 abstainers from cannabis during Alcohol Use Disorder (AUD) treatment, frequent cannabis use (12 times/month or more) was linked to significantly more physical alcohol-related consequences one year after treatment.

The findings suggest that individuals in AUD treatment who frequently use cannabis may benefit from reducing or stopping cannabis use to minimize the risk of alcohol-related physical problems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cannabis use during alcohol treatment is associated with alcohol-related problems one-year post-treatment. Subbaraman, MS., Metrik, J., Patterson, D., et al.[2023]

Only about 20% of individuals undergoing treatment for cannabis dependence achieve long-term abstinence, highlighting the need for more effective and accessible treatment options.

Psychotherapeutic strategies, especially combination therapies that include motivational interventions and behavioral skills training, have shown larger effect sizes for cannabis dependence compared to other substance use disorders, indicating their potential effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

State of the art treatments for cannabis dependence. Danovitch, I., Gorelick, DA.[2021]

Citations

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

Effectiveness of cannabis use and cannabis use disorder ... This data synthesis examined the effectiveness of behavioural and pharmacological approaches for cannabis treatment.

2. sciencedirect.com sciencedirect.com/science/article/pii/S2949875923000693

Monitoring adherence and abstinence of cannabis use ... Their results revealed that the patient profiles characterized by primarily joint and blunt use showed more problems in maintaining abstinence.

3. 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).

4. jci.org jci.org/articles/view/172887

Cannabis use disorder: from neurobiology to treatment For example, following 9 sessions of MET and CBT, improved abstinence rates and fewer days of cannabis use were observed among adults with CUD ...

5. mdpi.com mdpi.com/2076-3425/14/3/227

Treatments for Cannabis Use Disorder across the Lifespan The key efficacy outcome measures evaluated across included studies were abstinence, reduction in cannabis use frequency or quantity, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8655458/

Cannabis use and cannabis use Disorder - PMC Cannabis use disorder (CUD) is an underappreciated risk of using cannabis that affects ~10% of the 193 million cannabis users worldwide.

7. bmcpsychiatry.biomedcentral.com bmcpsychiatry.biomedcentral.com/articles/10.1186/s12888-024-05616-3

A phase III multisite randomised controlled trial to compare the ... This study examines the efficacy, safety and quality of life of longer-term CBD treatment for patients with moderate-to-severe CUD.