Personalized Feedback Intervention to Reduce Risky Cannabis Use.

• Sponsor: Centre for Addiction and Mental Health (Other)
• Overall Status: Completed
• CT.gov ID: NCT04060602
• Collaborator: (none)
• Enrollment: 747
• Location: 1
• Arms: 2
• Actual Duration (Months): 13.4
• Patients Per Site Per Month: 55.7

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Cannabis Use	Behavioral: Personalized Feedback; Behavioral: Education	N/A

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:

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).

Study Design

• Study Type: Interventional
• Actual Enrollment: 747 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Personalized Feedback Intervention to Reduce Risky Cannabis Use: Randomized Controlled Trial
• Actual Study Start Date: Sep 3, 2019
• Actual Primary Completion Date: Oct 15, 2020
• Actual Study Completion Date: Oct 15, 2020

Arms and Interventions

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.	Behavioral: Personalized Feedback; A report comparing the participant's cannabis use to peer usage, and summarizing problems experienced and risk associated with future use.; Behavioral: 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.
Active Comparator: Education This arm is provided educational materials about risky cannabis use.	Behavioral: 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.

Outcome Measures

Primary Outcome Measures

1. Cannabis Use in the last 30 days [3 and 6 months]

   Change in the number of days participant used cannabis in the past 30-days from baseline

Secondary Outcome Measures

1. Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST, cannabis subscale) [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.

2. Perceptions of Cannabis Use by Peers in the past 3 months [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre for Addiction Mental Health	Toronto	Ontario	Canada	M5S 2S1

Sponsors and Collaborators

• Centre for Addiction and Mental Health

Investigators

• Principal Investigator: John A Cunningham, Ph.D., Centre for Addiction and Mental Health

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• 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

Publications

None provided.

• Responsible Party: John Cunningham, Senior Scientist, Centre for Addiction and Mental Health
• ClinicalTrials.gov Identifier: NCT04060602
• Other Study ID Numbers: 143/2018
• First Posted: Aug 19, 2019
• Last Update Posted: Oct 27, 2020
• Last Verified: Oct 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Marijuana Abuse

Study Results

No Results Posted as of Oct 27, 2020