Personalized Feedback Intervention to Reduce Risky Cannabis Use.

Cannabis Use Clinical Trial

Official title:

Personalized Feedback Intervention to Reduce Risky Cannabis Use: Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04060602
• Other study ID #: 143/2018
• Status: Completed
• Phase: N/A
• Start date: September 3, 2019
• Est. completion date: October 15, 2020

Study information

• Verified date: October 2020
• Source: Centre for Addiction and Mental Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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:

1. 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).

2. 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.

3. 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 747
• Est. completion date: October 15, 2020
• Est. primary completion date: October 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Cannabis Use
• Marijuana Abuse

Intervention

Behavioral:
• Personalized Feedback
A report comparing the participant's cannabis use to peer usage, and summarizing problems experienced and risk associated with future use.
• Education
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.

Locations

Country	Name	City	State
Canada	Centre for Addiction Mental Health	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Centre for Addiction and Mental Health

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cannabis Use in the last 30 days	Change in the number of days participant used cannabis in the past 30-days from baseline	3 and 6 months
Secondary	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.	Baseline, 3 and 6 months
Secondary	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	Baseline, 3 months

External Links

•   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