Cognitive Behavioural Therapy for Cannabis Use Disorder

Overseen By Kevin Branson

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medical University of South Carolina

Disqualifiers: Psychosis, Mania, Pregnancy, 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: 4

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore the effectiveness of cognitive behavioral therapy (CBT) in reducing cannabis use. Participants will engage in an 8-week program, including one-on-one goal-setting with a therapist and seven weekly online CBT sessions. The study will gather information on cannabis use through diaries and biological tests. Individuals diagnosed with cannabis use disorder in the last month who seek help in reducing their use are well-suited for this trial. As an unphased trial, this study offers participants the opportunity to contribute to valuable research that could lead to new insights and treatments for cannabis use disorder.

Do I have to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the trial coordinators or your doctor.

What prior data suggests that Cognitive Behavioral Therapy (CBT4CBT) is safe for treating cannabis use disorder?

Research has shown that cognitive behavioral therapy (CBT), including CBT4CBT, is generally safe and well-tolerated by participants. Studies have found that this therapy can effectively reduce addiction-related problems, such as cannabis use. In fact, CBT has been linked to significant success in stopping substance use. While no specific negative effects have been reported for CBT4CBT, psychotherapy is non-invasive and doesn't involve medication, usually resulting in fewer side effects compared to drug treatments. Overall, past participants have typically found CBT to be a safe option for addressing cannabis use issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the use of Cognitive Behavioral Therapy for Cannabis Use Disorder (CBT4CBT) because it offers a novel, digital approach to tackling cannabis addiction. Unlike traditional in-person therapy sessions, CBT4CBT allows participants to engage in therapy through online modules, providing flexibility and accessibility. Additionally, the treatment includes motivational interviewing and continuous support from a therapist, which can enhance engagement and effectiveness. By examining gender and hormonal factors as predictors of success, this approach may also pave the way for more personalized and effective treatment strategies for both men and women struggling with cannabis use disorder.

What evidence suggests that Cognitive Behavioral Therapy might be an effective treatment for cannabis use disorder?

Research has shown that Cognitive Behavioral Therapy (CBT) can help people reduce cannabis use. In this trial, participants will receive CBT tailored to their gender, with separate arms for men and women. Studies have found that combining CBT with motivational interviewing leads to better results for those trying to cut back. Longer treatments, with more than four sessions, generally prove more effective than shorter ones. CBT has increased the number of people who remain off cannabis after treatment. Early follow-ups, conducted within one to six months after treatment, have shown small to moderate improvements in reducing cannabis use. Overall, CBT offers promising results for treating Cannabis Use Disorder (CUD). ^{3 6 7 8 9}

Who Is on the Research Team?

Aimee L McRae-Clark, PharmD

Principal Investigator

Medical University of South Carolina

Rachel L Tomko, PhD

Principal Investigator

Medical University of South Carolina

Are You a Good Fit for This Trial?

This trial is for adults over 18 who want to cut down on cannabis use and meet the criteria for Cannabis Use Disorder. They must have a positive urine test for cannabinoids and be interested in treatment, but not at risk of harm to self or others, pregnant, or dealing with severe mental health issues.

Inclusion Criteria

Submit a positive urine cannabinoid test during screening

Interested in treatment for cannabis use disorder

Meet current (within last 30 days) DSM-5 criteria for cannabis use disorder

Exclusion Criteria

The presence of any substance use disorder requiring a higher level of care

Significant risk of homicide or suicide

Pregnant, trying to become pregnant, or breastfeeding

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive an 8-week behavioral treatment program including 1 goals session with a therapist and 7 weekly computerized cognitive-behavioral therapy sessions. Daily electronic diaries and salivary samples are collected.

8 weeks

1 in-person visit, 7 virtual sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment with detailed cannabis assessments at 1-, 2-, and 3-months post-treatment completion.

3 months

3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Cognitive Behavioral Therapy (CBT4CBT)

Trial Overview

The study tests an 8-week program combining one-on-one counseling with weekly computerized cognitive-behavioral therapy sessions aimed at reducing cannabis use. Participants' usage is tracked through daily texts and saliva tests analyzing progesterone.

How Is the Trial Designed?

Group I: Cognitive Behavioral Therapy - Women Experimental Treatment 1 Intervention

112 participants identifying as women will be enrolled in 8 weeks of behavioral treatment for CUD. They will receive a motivational interviewing session with a therapist followed by 7 weekly online modules of CBT4CBT with continued monitoring and support from a therapist. Gender and hormonal factors will be examined as predictors of CUD remission and cannabis outcomes.

Group II: Cognitive Behavioral Therapy - Men Experimental Treatment 1 Intervention

112 participants identifying as men will be enrolled in 8 weeks of behavioral treatment for cannabis use disorder (CUD). They will receive a motivational interviewing session with a therapist followed by 7 weekly online modules of CBT4CBT with continued monitoring and support from a therapist. Gender and hormonal factors will be examined as predictors of CUD remission and cannabis outcomes.

Cognitive Behavioral Therapy (CBT4CBT) is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Cognitive Behavioral Therapy for:

• Cannabis Use Disorder

Approved in European Union as Cognitive Behavioral Therapy for:

• Cannabis Use Disorder
• Substance Use Disorders

Approved in Canada as Cognitive Behavioral Therapy for:

• Cannabis Use Disorder
• Mental Health Disorders

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials

994

Recruited

7,408,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Published Research Related to This Trial

A randomized controlled trial involving 229 participants showed that brief cognitive-behavioral interventions (CBT) can attract individuals seeking help for cannabis dependence, highlighting a significant demand for effective treatment options.

Participants reported severe cannabis dependence and high levels of psychological distress, with stress relief being the primary reason for use, indicating the need for targeted interventions that address both cannabis use and underlying mental health issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical profile of participants in a brief intervention program for cannabis use disorder. Copeland, J., Swift, W., Rees, V.[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]

Integrated cannabis and anxiety reduction treatment (ICART) was found to be more effective than standard motivation enhancement therapy combined with cognitive-behavioral therapy (MET-CBT) for individuals with severe cannabis use disorder and comorbid anxiety, as it led to reduced cannabis use and fewer related problems post-treatment.

The study involved 55 participants (27 in ICART and 28 in MET-CBT), and results indicated that ICART is particularly beneficial for those with higher baseline cannabis use, suggesting that tailored treatments can improve outcomes for patients with dual diagnoses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrated cognitive-behavioral therapy for comorbid cannabis use and anxiety disorders: The impact of severity of cannabis use. Buckner, JD., Morris, PE., Zvolensky, MJ.[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]

The study tested an integrated treatment called ICART, which combines transdiagnostic anxiety cognitive-behavioral therapy (CBT) with motivation enhancement therapy (MET) for individuals with cannabis use disorder (CUD) and comorbid anxiety disorders, showing that patients in the ICART group attended more sessions and had higher rates of abstinence post-treatment.

ICART was found to be at least as effective as the standard MET-CBT treatment, leading to significant decreases in cannabis use and related problems, indicating it may be a promising option for this challenging population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrated cognitive behavioral therapy for comorbid cannabis use and anxiety disorders: A pilot randomized controlled trial. Buckner, JD., Zvolensky, MJ., Ecker, AH., et al.[2020]

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 twelve-week intervention targeting both cannabis use disorders (CUD) and tobacco smoking showed that all six participants completed the cannabis treatment, and five achieved abstinence from cannabis, indicating that simultaneous treatment can be effective for cannabis outcomes.

While participation in the tobacco intervention was high, with 50% of participants starting nicotine replacement therapy, the actual quit attempts for tobacco were lower than expected, suggesting that more effective strategies are needed to improve tobacco cessation rates alongside CUD treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment models for targeting tobacco use during treatment for cannabis use disorder: case series. Lee, DC., Budney, AJ., Brunette, MF., et al.[2021]

A review of 207 studies identified only 3 randomized clinical trials (RCTs) specifically focused on using cannabidiol (CBD) for cannabis use disorder, highlighting a significant gap in research for CBD's efficacy in treating substance use disorders.

Ongoing trials are enhancing outcome measures by incorporating peripheral biomarkers from the endocannabinoid system, which may help predict how well individuals respond to CBD treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Trials of Cannabidiol for Substance Use Disorders: Outcome Measures, Surrogate Endpoints, and Biomarkers. Morel, A., Lebard, P., Dereux, A., et al.[2021]

Integrating a tobacco intervention with treatment for cannabis use disorders (CUD) was feasible for 32 participants over 12 weeks, showing that it can positively impact tobacco use without harming cannabis abstinence outcomes.

Participants achieved an average of 3.6 consecutive weeks of cannabis abstinence, similar to a historical control group, and over half initiated tobacco quit attempts, indicating that targeting both substances may enhance treatment effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes from a computer-assisted intervention simultaneously targeting cannabis and tobacco use. Lee, DC., Budney, AJ., Brunette, MF., et al.[2022]

A 12-week group treatment combining cognitive behavioral therapy (CBT) and motivational enhancement therapy (MET) significantly reduced cannabis use and improved related issues like craving and mood among participants seeking help for cannabis use disorder.

The study found that 57% of participants attended at least 75% of the sessions, indicating moderate retention, and overall client satisfaction was reported, suggesting the treatment is promising but needs further controlled studies to confirm its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation and Preliminary Evaluation of a 12-Week Cognitive Behavioural and Motivational Enhancement Group Therapy for Cannabis Use Disorder. Trick, L., Butler, K., Bourgault, Z., et al.[2023]

In a trial with 67 adults seeking treatment for cannabis use disorder, both simultaneous (SIM) and sequential (SEQ) tobacco cessation interventions showed no significant differences in treatment participation or cannabis use outcomes during the first 12 weeks.

While the majority of SIM participants engaged in tobacco counseling and made quit attempts, the SEQ group had lower continuation rates in treatment after their intervention was delayed, highlighting the potential risks of postponing tobacco cessation efforts in cannabis treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sequential and simultaneous treatment approaches to cannabis use disorder and tobacco use. Lee, DC., Walker, DD., Hughes, JR., et al.[2020]

Cannabidiol (CBD) has shown significant therapeutic potential for conditions like refractory epilepsy in children, with pharmacological properties such as neuroprotection and anti-inflammatory effects, without the psychotropic effects associated with Δ(9)-THC.

Despite its promise, there are ongoing uncertainties regarding the long-term safety, sourcing, and regulatory challenges of CBD, which are critical for its further clinical development and acceptance in medical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current Status and Prospects for Cannabidiol Preparations as New Therapeutic Agents. Fasinu, PS., Phillips, S., ElSohly, MA., et al.[2018]

CBT4CBT, a computer-based cognitive-behavioral therapy, was found to be a safe and effective stand-alone treatment for individuals with substance use disorders, showing significant reductions in substance use compared to standard treatment after six months.

Participants using CBT4CBT reported higher satisfaction and better understanding of cognitive and behavioral concepts than those receiving traditional clinician-delivered CBT, which had a higher dropout rate and less effectiveness at follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized Clinical Trial of Computerized and Clinician-Delivered CBT in Comparison With Standard Outpatient Treatment for Substance Use Disorders: Primary Within-Treatment and Follow-Up Outcomes. Kiluk, BD., Nich, C., Buck, MB., et al.[2019]

In a study of 198 participants with anxiety disorders, treatment with various cannabis formulations significantly improved quality of life outcomes, including reductions in anxiety, depression, and fatigue, as well as enhanced social functioning.

Common adverse events reported included dry mouth, somnolence, and fatigue, with gastrointestinal issues more prevalent in formulations containing THC, indicating a need for careful consideration of cannabis formulation in treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effectiveness and Adverse Events of Cannabidiol and Tetrahydrocannabinol Used in the Treatment of Anxiety Disorders in a PTSD Subpopulation: An Interim Analysis of an Observational Study. Stack, SK., Wheate, NJ., Moloney, NC., et al.[2023]

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