Cognitive Behavioral Therapy for Alcoholism and Cannabis Abuse

Overseen By Kelly Xiao, MSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Centre for Addiction and Mental Health

Disqualifiers: Suicidal ideation, Unstable psychiatric, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

400 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests cognitive behavioral therapy (CBT) to help individuals with alcohol or cannabis use disorders. The goal is to determine CBT's effectiveness in reducing dependency on these substances. Participants with alcohol use disorder may also receive medication as part of their treatment. This study suits those who have been drinking more than 10 drinks per week (for women) or 15 drinks (for men) or using cannabis nearly every day recently and are willing to participate in group therapy. As an unphased trial, it offers the opportunity to contribute to understanding and improving treatment options for substance use disorders.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, you must be able to safely abstain from alcohol and cannabis for 12 hours before assessments.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Cognitive Behavioral Therapy (CBT) is generally safe and well-tolerated. For individuals with alcohol use disorder, studies indicate that CBT can significantly reduce drinking and increase sobriety rates. No major safety concerns have been reported with using CBT for alcohol use disorder.

For cannabis use disorder, combining CBT with motivational enhancement therapy (MET) is also considered safe. Research suggests that more than four sessions enhance treatment effectiveness. No serious side effects have been noted with CBT for cannabis use disorder.

Overall, CBT is a non-invasive therapy involving talking sessions. It doesn't use medication, avoiding many side effects associated with drugs, making it a safe option for those dealing with alcohol or cannabis use issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Cognitive Behavioral Therapy (CBT) for alcohol and cannabis use disorders because it offers a holistic approach that goes beyond traditional treatment methods like medication or basic counseling. Unlike typical treatments that focus solely on stopping substance use, CBT targets the underlying thought patterns and behaviors that contribute to addiction, empowering individuals with skills to manage triggers and prevent relapse. Additionally, the integration of motivational enhancement therapy for cannabis use disorder provides a supportive environment that encourages personal motivation for change, which can be more engaging and effective. This combined approach not only addresses the immediate substance use but also equips participants with long-term coping strategies, offering a comprehensive path to recovery.

What evidence suggests that this trial's treatments could be effective for alcohol and cannabis use disorders?

Research shows that Cognitive Behavioral Therapy (CBT) effectively treats alcohol use problems. In this trial, participants with Alcohol Use Disorder will undergo 12 weeks of CBT, with the option to receive evidence-based pharmacotherapy for AUD guided by a pharmacotherapy algorithm. Studies have found that CBT helps people reduce their drinking and is more effective than no treatment or minimal intervention. For cannabis use problems, participants will receive a combination of CBT and motivational enhancement therapy (MET) for Cannabis Use Disorder. This combination has shown good results, especially when therapy lasts more than four weeks, leading to better outcomes. Previous studies reported that about 20-30% of participants stopped using cannabis within 6 to 12 months after completing CBT. Overall, CBT is a strong option for addressing both alcohol and cannabis use issues. ^{2 6 7 8 9}

Who Is on the Research Team?

Matthew Sloan, MD

Principal Investigator

Centre for Addiction and Mental Health

Are You a Good Fit for This Trial?

This trial is for adults over 18 who have been diagnosed with alcohol use disorder (AUD) or cannabis use disorder (CUD), are willing to participate in group therapy, and can abstain from substances before assessments. They must meet specific criteria for risky drinking or frequent cannabis use. Those unable to communicate in English or unwilling to follow the study's abstinence requirements cannot join.

Inclusion Criteria

I can speak and understand English well enough to give informed consent.

I can avoid alcohol, cannabis, and other substances (except tobacco) for 12 hours before tests.

Meets criteria for risky drinking, defined as > 10 drinks per week for females and > 15 drinks per week for males on average over the past 30 days (AUD group) or daily or near-daily cannabis use over the past 30 days, defined as ≥ 4 days of cannabis use per week on average (CUD group)

Exclusion Criteria

Active suicidal ideation at time of assessment

Suicide attempt within the past month

Unstable psychiatric or medical status (e.g., acute psychosis or mania) or unstable use of another substance that may interfere with participation in groups (e.g. active fentanyl use)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo thorough baseline assessments of executive function, incentive salience, and negative emotionality

1-2 weeks

Treatment

Participants receive 12 weeks of cognitive behavioral therapy (CBT) for their respective disorders, with optional pharmacotherapy for AUD and motivational enhancement therapy for CUD

12 weeks

Weekly group therapy sessions

Follow-up

Participants are monitored for changes in drug consumption, craving, and other psychological measures

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• CBT

Trial Overview The study tests if assessing three brain functions—executive function, incentive salience, and negative emotionality—before treatment can predict how well people with AUD or CUD respond to therapy. Participants will receive 12 weeks of cognitive behavioral therapy (CBT), with additional pharmacotherapy for AUD if needed.

How Is the Trial Designed?

Group I: Cannabis Use Disorder Experimental Treatment 1 Intervention

Participants will be treated with 12 weeks of CBT + motivational enhancement therapy for CUD (group therapy).

Group II: Alcohol Use Disorder Experimental Treatment 1 Intervention

Participants will be treated with 12 weeks of CBT for AUD (group therapy) and have the option to receive evidence-based pharmacotherapy for AUD guided by a pharmacotherapy algorithm.

Who Is Running the Clinical Trial?

Centre for Addiction and Mental Health

Lead Sponsor

Trials

388

Recruited

84,200+

Innovation Fund of the Alternative Funding Plan for the Academic Health Sciences Centres of Ontario

Collaborator

Trials

1

Recruited

400+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

AFP Innovation Fund

Collaborator

Trials

9

Recruited

1,500+

Published Research Related to This Trial

Cognitive Behaviour Therapy (CBT) shows limited effectiveness for treating co-occurring depression and substance use, with only modest improvements compared to no treatment, based on a review of 12 clinical trials.

While CBT is not proven to be more effective than other psychotherapies, it does lead to consistent improvements in both depression and substance use outcomes, and these benefits appear to increase over time during follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive behaviour therapy (CBT) for the treatment of co-occurring depression and substance use: current evidence and directions for future research. Hides, L., Samet, S., Lubman, DI.[2018]

A study involving 68 individuals with alcohol use disorders showed that those receiving web-based cognitive behavioral therapy (CBT4CBT) had significantly higher treatment completion rates and greater increases in the percentage of days abstinent compared to standard treatment alone.

The web-based CBT4CBT program was found to be safe and feasible, with preliminary evidence suggesting it may reduce the costs of alcohol use disorder-related services compared to standard treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized Trial of Computerized Cognitive Behavioral Therapy for Alcohol Use Disorders: Efficacy as a Virtual Stand-Alone and Treatment Add-On Compared with Standard Outpatient Treatment. Kiluk, BD., Devore, KA., Buck, MB., et al.[2018]

In a study of 140 adults with cocaine use disorder undergoing web-based cognitive-behavior therapy (CBT), higher baseline positive affect (PA) was linked to less frequent cocaine use during treatment, suggesting that enhancing positive emotions may improve treatment outcomes.

While negative affect (NA) scores decreased over time in both CBT and treatment as usual, higher NA during treatment was associated with increased cocaine use, indicating that managing negative emotions could be crucial for successful recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Positive and negative affect in cocaine use disorder treatment: Change across time and relevance to treatment outcome. Decker, SE., Morie, KP., Malin-Mayo, B., 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]

A study involving 55 patients with alcohol use disorder showed that interactive, personalized computer-based cognitive behavioral therapy (CBT) was effective, leading to significant reductions in alcohol consumption and increased abstinence rates over a 3-month follow-up.

Both the computer-based CBT and placebo groups improved in their drinking outcomes, but the CBT group showed greater engagement in Alcoholics Anonymous and better self-efficacy regarding alcohol use, suggesting that computer-based CBT could be a valuable tool in treating AUD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computerised cognitive behavioural therapy for alcohol use disorder: a pilot randomised control trial. Farren, CK., Milnes, J., Lambe, K., et al.[2019]

Cognitive Behavioral Therapy (CBT) is an effective treatment for adults with alcohol or other drug use disorders, showing significant efficacy compared to minimal care and usual care control conditions.

While CBT can be combined with other treatments like Motivational Interviewing and pharmacotherapy for better outcomes, it does not consistently outperform other established treatment methods, and its mechanisms of action require further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Cognitive Behavioral Therapy for Alcohol and Other Drug Use Disorders: Is a One-Size-Fits-All Approach Appropriate? Magill, M., Kiluk, BD., Ray, LA.[2023]

The combination of cognitive behavioral therapy (CBT) and transdermal nicotine replacement therapy (NRT) significantly reduced tobacco smoking in participants, from an average of 12.6 cigarettes per day to 2.1 by the end of the 10-week treatment.

While cannabis use did not significantly decrease, the study suggests that treating both nicotine and cannabis dependence simultaneously is safe, as there was no increase in cannabis use when tobacco smoking was reduced, and participants reported high satisfaction with the treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive behavioral therapy and the nicotine transdermal patch for dual nicotine and cannabis dependence: a pilot study. Hill, KP., Toto, LH., Lukas, SE., et al.[2021]

A study involving 63 participants found that adding computer-based cognitive behavioral therapy (CBT4CBT) to standard treatment for alcohol use disorder (AUD) was more effective and cost-effective than standard treatment alone, costing about $35.08 for each additional day of reduced drinking.

While CBT4CBT+monitoring was slightly less costly and more effective than standard treatment, overall treatment costs did not significantly differ across conditions, indicating that further research is needed to fully understand the cost-benefit of computer-delivered CBT for AUD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot economic evaluation of computerized cognitive behavioral therapy for alcohol use disorder as an addition and alternative to traditional therapy. Kacmarek, CN., Yates, BT., Nich, C., et al.[2023]

A randomized controlled trial involving 229 participants demonstrated that both six-session (6CBT) and single-session (1CBT) cognitive-behavioral interventions significantly improved treatment outcomes for cannabis dependence compared to a delayed-treatment control group.

Participants in the 6CBT group not only reported higher rates of abstinence but also experienced a greater reduction in cannabis consumption and related problems, highlighting the effectiveness of structured CBT in promoting cannabis cessation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of brief cognitive-behavioral interventions for cannabis use disorder. Copeland, J., Swift, W., Roffman, R., et al.[2022]

Citations

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Efficacy of Cognitive Behavioral Therapy for Alcohol and ... We provide an overview of Cognitive Behavioral Therapy (CBT) efficacy for adult alcohol or other drug use disorders (AOD) and consider some ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6856400/

A Meta-Analysis of Cognitive-Behavioral Therapy for ... The current meta-analysis shows that CBT is more effective than a no treatment, minimal treatment, or non-specific control.

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A Digital Cognitive Behavioral Therapy Program for Adults ... Findings In this randomized clinical trial with 99 participants seeking treatment for alcohol use disorder, those assigned to digital CBT plus ...

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Journal of Consulting and Clinical Psychology Cognitive-behavioral therapy (CBT) is a leading behavioral approach for intervention with alcohol or other drug use disor- ders (Substance Abuse and Mental ...

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The effects of cognitive behavioral therapy-based digital ... IntroductionThis study investigated the effectiveness of a digital therapeutic intervention for individuals with alcohol use problems.

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A Digital Cognitive Behavioral Therapy Program for Adults ... Mean (SD) rates of PDA from baseline to 6-month follow-up were 49.3% (27.8%) to 69.6% (34.4%) for TAU; 53.7% (29.8%) to 70.2% (35.1%) for CBT; ...

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Cognitive Behavioral Interventions for Alcohol and Drug ... Three and six-month follow-up indicated significant reductions in drinking outcomes, but no significant differences between conditions (PDA at 3 months follow ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0376871625002091

Cognitive-behavioral interventions for co-occurring ... The current meta-analysis provides an overview of cognitive-behaviorally-based interventions (CBI) that treat co-occurring alcohol and other drug use (AOD)

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Yale Study: Digital Cognitive Behavioral Therapy Program ... Study results revealed the digital program plus brief monitoring outperformed clinician-delivered CBT in terms of increasing alcohol abstinence, ...