NCT04965012

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
152

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2022

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 6, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 16, 2021

Completed
1.1 years until next milestone

Study Start

First participant enrolled

August 25, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
Last Updated

December 1, 2023

Status Verified

November 1, 2023

Enrollment Period

1.1 years

First QC Date

July 6, 2021

Last Update Submit

November 30, 2023

Conditions

Keywords

CannabisCANreduceMarijuanaCognitive Behavioural TherapyMotivational Enhancement TherapyOnline treatmentRandomized Controlled Trial

Outcome Measures

Primary Outcomes (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.

    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)

  • Cannabis-Related Problems

    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).

  • Anxiety

    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).

  • Depression

    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).

  • Quality of Life

    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).

Study Arms (3)

CBT with MET treatment group

EXPERIMENTAL

Participants in this arm will be provided with an MET-therapist guided introduction, in addition to the online CBT treatment.

Behavioral: Online CBT with MET treatment

CBT without MET treatment group

EXPERIMENTAL

Participants 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.

Behavioral: CBT without MET treatment

Psychoeducation (Control)

NO INTERVENTION

The control group will be provided with psychoeducational resources about cannabis and wellbeing.

Interventions

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 with MET treatment group

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.

CBT without MET treatment group

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Manitoba

Winnipeg, Manitoba, Canada

Location

York University

Toronto, Ontario, Canada

Location

Related Publications (1)

  • 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. doi: 10.1186/s42238-025-00378-5. Online ahead of print.

MeSH Terms

Conditions

Marijuana UseMarijuana Abuse

Condition Hierarchy (Ancestors)

BehaviorSubstance-Related DisordersMental DisordersChemically-Induced Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 6, 2021

First Posted

July 16, 2021

Study Start

August 25, 2022

Primary Completion

October 1, 2023

Study Completion

October 1, 2023

Last Updated

December 1, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations