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Personalized Feedback Intervention to Reduce Risky Cannabis Use.

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ClinicalTrials.gov Identifier: NCT04060602
Recruitment Status : Recruiting
First Posted : August 19, 2019
Last Update Posted : September 5, 2019
Sponsor:
Information provided by (Responsible Party):
John Cunningham, Centre for Addiction and Mental Health

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 Not Applicable

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).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 740 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 : September 3, 2019
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04060602


Contacts
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Contact: John A Cunningham, Ph.D. 416-535-8501 john.cunningham@camh.ca
Contact: Christina Schell 416-535-8501 ext 33356 christina.schell@camh.ca

Locations
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Canada, Ontario
Centre for Addiction Mental Health Recruiting
Toronto, Ontario, Canada, M5S 2S1
Contact: John A Cunningham, Ph.D.    416-535-8501    john.cunningham@camh.ca   
Sponsors and Collaborators
Centre for Addiction and Mental Health
Investigators
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Principal Investigator: John A Cunningham, Ph.D. Centre for Addiction and Mental Health

Additional Information:
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Responsible Party: John Cunningham, Senior Scientist, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier: NCT04060602     History of Changes
Other Study ID Numbers: 143/2018
First Posted: August 19, 2019    Key Record Dates
Last Update Posted: September 5, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Marijuana Abuse
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders