- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04060602
Personalized Feedback Intervention to Reduce Risky Cannabis Use.
Personalized Feedback Intervention to Reduce Risky Cannabis Use: Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This project aims to reduce risky cannabis use among those with less severe cannabis use, most of whom will never seek formal treatment. All of the participants will receive educational material regarding risky cannabis use and its prevention. Half of the participants will also be assigned by chance to receive a personalized feedback report.
The investigators hypothesize that:
- Participants who receive the full personalized feedback intervention will be less likely to report risky cannabis use at 3- and 6-month follow-ups compared to participants who receive educational materials only (Primary Hypothesis).
- Participants who receive the full personalized feedback intervention will report greater reductions in their perceptions of how much others use cannabis at a 3-month follow-up compared to participants who receive educational materials only.
- Reductions in perceptions of how much others use cannabis at 3-month follow-up will be positively associated with reduction in the participant's risky cannabis use at 6-month follow-up.
A 2-arm parallel group randomized controlled trial will be conducted to test these hypotheses with follow-ups occurring at 3 and 6 months after randomization. Online media advertisements will be used to recruit people currently using cannabis. The advertisements will be placed across Canada using locations found successful in previous trials to rapidly recruit participants (e.g. Google AdWords).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5S 2S1
- Centre for Addiction Mental Health
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Score of 4 or more on the Alcohol, Smoking, and Substance Involvement Screening Test, Cannabis subscale (ASSIST)
Exclusion Criteria:
- Being under 18 years of age
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Personalized Feedback and Education
This arm is provided personalized feedback concerning their cannabis use in addition to educational materials about risky cannabis use.
|
A report comparing the participant's cannabis use to peer usage, and summarizing problems experienced and risk associated with future use.
Canada's Lower-Risk Cannabis Use Guidelines prepared by the Centre for Addiction and Mental Health which outlines methods to help reduce health risks associated with cannabis use.
|
|
Active Comparator: Education
This arm is provided educational materials about risky cannabis use.
|
Canada's Lower-Risk Cannabis Use Guidelines prepared by the Centre for Addiction and Mental Health which outlines methods to help reduce health risks associated with cannabis use.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cannabis Use in the last 30 days
Time Frame: 3 and 6 months
|
Change in the number of days participant used cannabis in the past 30-days from baseline
|
3 and 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST, cannabis subscale)
Time Frame: Baseline, 3 and 6 months
|
Change in cannabis subscale scores from baseline.
Scores are calculated as a sum of six items and totals can range from 0 to 39 with higher scores indicating greater risk.
|
Baseline, 3 and 6 months
|
|
Perceptions of Cannabis Use by Peers in the past 3 months
Time Frame: Baseline, 3 months
|
Change in participant's perceptions of how much their peers (same age and gender) use cannabis.
Measured as a percentage of peers that do not use cannabis (%) and a 5-points Likert scale, 0 "Never" to 5 "Daily or Almost daily" of frequency of peer use
|
Baseline, 3 months
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 143/2018
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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