Personalized Feedback Intervention to Reduce Risky Cannabis Use.
Primary Purpose
Cannabis Use
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Personalized Feedback
Education
Sponsored by
About this trial
This is an interventional treatment trial for Cannabis Use
Eligibility Criteria
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
Sites / Locations
- Centre for Addiction Mental Health
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Personalized Feedback and Education
Education
Arm Description
This arm is provided personalized feedback concerning their cannabis use in addition to educational materials about risky cannabis use.
This arm is provided educational materials about risky cannabis use.
Outcomes
Primary Outcome Measures
Cannabis Use in the last 30 days
Change in the number of days participant used cannabis in the past 30-days from baseline
Secondary Outcome Measures
Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST, cannabis subscale)
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.
Perceptions of Cannabis Use by Peers in the past 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
Full Information
NCT ID
NCT04060602
First Posted
August 16, 2019
Last Updated
October 26, 2020
Sponsor
Centre for Addiction and Mental Health
1. Study Identification
Unique Protocol Identification Number
NCT04060602
Brief Title
Personalized Feedback Intervention to Reduce Risky Cannabis Use.
Official Title
Personalized Feedback Intervention to Reduce Risky Cannabis Use: Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
September 3, 2019 (Actual)
Primary Completion Date
October 15, 2020 (Actual)
Study Completion Date
October 15, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre for Addiction and Mental Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this project is to determine whether participants who receive a personalized feedback report and educational materials about risky cannabis use will be less likely to report risky cannabis use at follow-up compared to participants who only received educational materials.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cannabis Use
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
747 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Personalized Feedback and Education
Arm Type
Experimental
Arm Description
This arm is provided personalized feedback concerning their cannabis use in addition to educational materials about risky cannabis use.
Arm Title
Education
Arm Type
Active Comparator
Arm Description
This arm is provided educational materials about risky cannabis use.
Intervention Type
Behavioral
Intervention Name(s)
Personalized Feedback
Intervention Description
A report comparing the participant's cannabis use to peer usage, and summarizing problems experienced and risk associated with future use.
Intervention Type
Behavioral
Intervention Name(s)
Education
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cannabis Use in the last 30 days
Description
Change in the number of days participant used cannabis in the past 30-days from baseline
Time Frame
3 and 6 months
Secondary Outcome Measure Information:
Title
Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST, cannabis subscale)
Description
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.
Time Frame
Baseline, 3 and 6 months
Title
Perceptions of Cannabis Use by Peers in the past 3 months
Description
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
Time Frame
Baseline, 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John A Cunningham, Ph.D.
Organizational Affiliation
Centre for Addiction and Mental Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre for Addiction Mental Health
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5S 2S1
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
http://www.camh.ca/en/research
Description
Description Information about research at the Centre for Addiction and Mental Health, Canada's largest mental health and addiction teaching hospital, fully affiliated with the University of Toronto, and a PAHO/WHO Collaborating Centre
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Personalized Feedback Intervention to Reduce Risky Cannabis Use.
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