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Marijuana UseNCT04965012

Testing the Efficacy of an Online Treatment Program for Heavy Cannabis Use

A study testing Online CBT with MET treatment and CBT without MET treatment in people with Marijuana Use and Marijuana Dependence, run by York University at 2 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Cannabis is a frequently-used psychoactive substance. While the majority of individuals can use cannabis without experiencing problems, a small minority of people develop cannabis problems. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Marijuana Use, Marijuana Dependence
What is being tested?
Online CBT with MET treatment and CBT without MET treatment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
152 participants
Where
2 sitesCanada
Study dates
25 Aug 2022to 1 Oct 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Ages 19+
  • Living in Manitoba or Ontario, Canada
  • Reporting moderate difficulties with cannabis as indicated by a score of 8 or more on the Cannabis Use Disorders Identification Test - Revised (CUDIT-R; Adamson et al., 2010)
  • Fluency in English
  • Having weekly Internet access with a device that allows for video connection
  • Self-report at least a 6 out of 10 on a Likert-type scale for motivation to reduce cannabis use (i.e., how important it is to reduce cannabis use)

Who cannot join

  • Self-reported engagement in other psychological or pharmacological treatments for cannabis use
  • Elevated suicidality, as defined by scoring greater than minimal risk on a screener
  • Current serious psychiatric disorders or history of psychosis, schizophrenia, bipolar disorder
  • Are a woman who is currently pregnant or breastfeeding

Trial locations and contacts

2 sites in 1 country.

Canada2 sites

  • York University

    Toronto, Ontario

  • University of Manitoba

    Winnipeg, Manitoba

Other trials in Canada

About this study

Official title: Testing the Efficacy of an Online Evidence-Based Treatment for Heavy Cannabis Use in Canadian Adults: A Randomized Controlled Trial (RCT)

Cannabis is a frequently-used psychoactive substance. While the majority of individuals can use cannabis without experiencing problems, a small minority of people develop cannabis problems. Despite the small-to-medium reported effect sizes of cognitive behavioural therapy (CBT) and motivational enhancement therapy (MET) treatments for cannabis misuse, many cannabis users do not seek treatment. Online CBT/MET programs have the potential to be cost-effective and accessible, and offer a less stigmatizing option for treatment. These programs may also help capture cannabis users who experience subclinical problems, who are not captured by traditional treatment. Existing treatment programs also need to be adapted to maximize participant retention and increase treatment completion, as many current cannabis use treatment programs have significant drop-out rates. Hence, the goal of the proposed randomized controlled trial (RCT) is to examine the efficacy of an online evidence-based CBT/MET treatment program. Outcomes of a combined CBT/MET treatment program will be compared to a CBT-only treatment program and a waitlist control. This research will provide insight into the novel contribution of MET to online CBT treatment programs for cannabis misuse.

The researchers are hoping to recruit 303 participants for this study from Central and Eastern Canada. Participants will be randomly assigned to one of the treatment groups (i.e., CBT with MET, CBT without MET) or the psychoeducational control group. Individuals in either treatment group will be given 6 weeks to work through 8 online modules. Throughout the modules, participants will identify goals related to cannabis use, learn strategies to cope with cannabis cravings, triggers, and social pressures and learn to prevent relapse. Participants randomly assigned to the control (i.e., psychoeducation) will receive links to websites that provide general psychoeducation about cannabis use and wellbeing. All participants will complete online assessment measures at baseline, end of treatment, and at follow up approximately one month later (i.e., 0 weeks, 6 weeks, 10 weeks) in order to assess the efficacy of the treatment. At the end of the study, individuals in the control group will be given access to the CBT without MET treatment.

Being tested
Online CBT with MET treatment, CBT without MET treatment
Keywords
Cannabis, CANreduce, Marijuana, Cognitive Behavioural Therapy, Motivational Enhancement Therapy, Online treatment, Randomized Controlled Trial
Medical subject headings
Marijuana Use, Marijuana Abuse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Online CBT with MET treatmentBehavioural

    The CBT with MET treatment condition will begin with an MET-therapist guided introduction to the program and first module. After this guided introduction, they will have access to the remaining 7 treatment modules and have 6 weeks to complete them. The content of all modules is derived from Cognitive Behavioural Therapy and Motivational Interviewing. Through module engagement, participants will identify goals related to cannabis use, learn strategies to cope with cravings, triggers, and social pressures, and learn to how prevent relapse. Participants will work through modules sequentially.

  • CBT without MET treatmentBehavioural

    The CBT without MET treatment condition will begin with a brief non-MET trained research assistant welcome to the program, and will not include working through the first module together. After this welcome, they will have access to the 8 treatment modules and have 6 weeks to complete them. The content of all modules is derived from Cognitive Behavioural Therapy and Motivational Interviewing. Through module engagement, participants will identify goals related to cannabis use, learn strategies to cope with cravings, triggers, and social pressures, and learn to how prevent relapse. Participants will work through modules sequentially.

Study groups in NCT04965012
Study groupRoleWhat they receive
CBT with MET treatment groupExperimentalParticipants in this arm will be provided with an MET-therapist guided introduction, in addition to the online CBT treatment.
Receives: Behavioral: Online CBT with MET treatment
CBT without MET treatment groupExperimentalParticipants in this arm will be provided with a brief non-MET research assistant-led welcome to the program, in addition to the online CBT treatment.
Receives: Behavioral: CBT without MET treatment
Psychoeducation (Control)No interventionThe control group will be provided with psychoeducational resources about cannabis and wellbeing.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Cannabis Use

    The Daily Sessions, Frequency, Age of Onset, and Quantity of Cannabis Use Inventory (DFAQ-CU; Cuttler \& Spradlin, 2017) is a self-report inventory of cannabis use that will be used as the primary assessment of cannabis use. The frequency (i.e., number of days per week) and quantity (i.e., grams) of cannabis use subscales will be used. There is mixed evidence as to whether frequency or quantity better predicts cannabis-related severity, thus information on both will be analyzed.

    Measured: Participants will be assessed using the DFAQ-CU at three time points (i.e., prior to treatment; T0); immediately following the 6-week treatment (T1), and at follow-up (i.e., 10 weeks from baseline, 4 weeks from end of treatment, T2).

Secondary outcomes (4)

  1. Cannabis-Related Problems

    The Cannabis Use Disorders Identification Test-Revised (CUDIT-R; Adamson et al., 2010), is an 8-item self-report questionnaire that will be used to assess problematic cannabis misuse characteristic of Cannabis Use Disorder (CUD).

    Measured: Participants will be assessed using the CUDIT-R at three time points (i.e., prior to treatment; T0); immediately following the 6-week treatment (T1), and at follow-up (i.e., 10 weeks from baseline, 4 weeks from end of treatment, T2).

  2. Anxiety

    The General Anxiety Disorder Scale (GAD-7; Spitzer et al., 2006) is a 7-item self-report anxiety questionnaire that will be used to assess overall anxiety severity.

    Measured: Participants will be assessed using the GAD-7 at three time points (i.e., prior to treatment; T0); immediately following the 6-week treatment (T1), and at follow-up (i.e., 10 weeks from baseline, 4 weeks from end of treatment, T2).

  3. Depression

    The Patient Health Questionnaire (PHQ-9; Kroenke et al., 2001) is a 9-item self-report of depression symptoms that will be used to assess overall depression severity.

    Measured: Participants will be assessed using the PHQ-9 at three time points (i.e., prior to treatment; T0); immediately following the 6-week treatment (T1), and at follow-up (i.e., 10 weeks from baseline, 4 weeks from end of treatment, T2).

  4. Quality of Life

    The World Health Organization Quality of Life Assessment (WHOQOL-BREF; WHOQOL Group, 1998) is a 26-item self-report measure that will be used to assess quality of life.

    Measured: Participants will be assessed using the WHOQOL-BREF at three time points (i.e., prior to treatment; T0); immediately following the 6-week treatment (T1), and at follow-up (i.e., 10 weeks from baseline, 4 weeks from end of treatment, T2).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jul 2021
  2. Study start25 Aug 2022
  3. Primary completion1 Oct 2023
  4. Study completion1 Oct 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
A three-arm RCT will be conducted to evaluate the proposed online intervention. Eligible participants will be randomized to the CBT with MET condition, the CBT without MET condition, or the psychoeducational control (i.e., control) condition.
Masking
None (open label)
Enrolment
152 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04965012
Sponsor's protocol ID
YM8974384y57393848938nv8493478
Status last verified
Nov 2023
First submitted
6 Jul 2021
Last updated
1 Dec 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Rysen KK, Mackenzie CS, Carusone JM, Schaub MP, Wenger A, Wallbridge H, Edgerton JD, Kruk R, Keough MT. Lessons learned: challenges in recruiting and engaging people with heavy cannabis use for online interventions in Canada. J Cannabis Res. 2026 Apr 16;8(1):70. doi: 10.1186/s42238-026-00425-9.

    PubMed 41992268

  • Rysen KK, Carusone JM, Wardell JD, Schaub MP, Wenger A, Wallbridge H, Edgerton JD, Kruk R, Mackenzie CS, Keough MT. Evidence-based therapist guided introduction to online heavy cannabis use treatment in Canadian adults: a Randomized Controlled Trial (RCT). J Cannabis Res. 2026 Jan 17;8(1):26. doi: 10.1186/s42238-025-00378-5.

    PubMed 41547862

Questions about this trial

What is this clinical trial studying?

A study testing Online CBT with MET treatment and CBT without MET treatment in people with Marijuana Use and Marijuana Dependence, run by York University at 2 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Cannabis Use (time frame: Participants will be assessed using the DFAQ-CU at three time points (i.e., prior to treatment; T0); immediately following the 6-week treatment (T1), and at follow-up (i.e., 10 weeks from baseline, 4 weeks from end of treatment, T2).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04965012, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2023.

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