Cannabis UseNCT04060602
Personalized Feedback Intervention to Reduce Risky Cannabis Use.
A study testing Personalized Feedback and Education in people with Cannabis Use, run by Centre for Addiction and Mental Health at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Cannabis Use
- What is being tested?
- Personalized Feedback and Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 747 participants
- Where
- 1 siteCanada
- Study dates
- 3 Sep 2019to 15 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Score of 4 or more on the Alcohol, Smoking, and Substance Involvement Screening Test, Cannabis subscale (ASSIST)
Who cannot join
- Being under 18 years of age
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Personalized Feedback Intervention to Reduce Risky Cannabis Use: Randomized Controlled Trial
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.
Read the 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).
- Conditions
- Cannabis Use
- Being tested
- Personalized Feedback, Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized FeedbackBehavioural
A report comparing the participant's cannabis use to peer usage, and summarizing problems experienced and risk associated with future use.
EducationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Personalized Feedback and Education | Experimental | This arm is provided personalized feedback concerning their cannabis use in addition to educational materials about risky cannabis use. Receives: Behavioral: Personalized Feedback; Behavioral: Education |
| Education | Active comparator | This arm is provided educational materials about risky cannabis use. Receives: Behavioral: Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cannabis Use in the last 30 days
Change in the number of days participant used cannabis in the past 30-days from baseline
Measured: 3 and 6 months
Secondary outcomes (2)
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.
Measured: Baseline, 3 and 6 months
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
Measured: Baseline, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2019
- Study start3 Sep 2019
- Primary completion15 Oct 2020
- Study completion15 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cannabis UseStudies of the same condition, open and under way.
- More trials run by Centre for Addiction and Mental HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 747 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Cunningham, Centre for Addiction and Mental Health
- Investigators
- John A Cunningham, Ph.D., Principal investigator, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04060602
- Sponsor's protocol ID
- 143/2018
- Status last verified
- Oct 2020
- First submitted
- 16 Aug 2019
- Last updated
- 27 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cunningham JA, Schell C, Bertholet N, Wardell JD, Quilty LC, Godinho A. Normative Misperceptions About Cannabis Use in a Sample of Risky Cannabis Users. Subst Abuse. 2023 Apr 6;17:11782218231166809. doi: 10.1177/11782218231166809. eCollection 2023.
PubMed 37051014
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Feedback Intervention to Reduce Risky Cannabis Use: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04060602
- Acronym / sponsor ID
- 143/2018
- Conditions
- Cannabis Use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 747 participants (actual)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Study start
- 3 Sep 2019 (actual)
- Primary completion
- 15 Oct 2020 (actual)
- Study completion
- 15 Oct 2020 (actual)
- First posted
- 19 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Personalized Feedback and Education | Experimental | Behavioral: Personalized Feedback, Behavioral: EducationThis arm is provided personalized feedback concerning their cannabis use in addition to educational materials about risky cannabis use. |
| Education | Active comparator | Behavioral: EducationThis arm is provided educational materials about risky cannabis use. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Score of 4 or more on the Alcohol, Smoking, and Substance Involvement Screening Test, Cannabis subscale (ASSIST)
Key exclusion criteria (1 listed)
- Being under 18 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personalized FeedbackA report comparing the participant's cannabis use to peer usage, and summarizing problems experienced and risk associated with future use. | Behavioural | Personalized Feedback and Education |
| EducationCanada'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. | Behavioural | Education, Personalized Feedback and Education |
Primary outcome
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
2 secondary outcomes
Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST, cannabis subscale)
Time frame: Baseline, 3 and 6 months
Perceptions of Cannabis Use by Peers in the past 3 months
Time frame: Baseline, 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2020.
- Derived from this study: PubMed 37051014Cunningham JA, Schell C, Bertholet N, Wardell JD, Quilty LC, Godinho A. Normative Misperceptions About Cannabis Use in a Sample of Risky Cannabis Users. Subst Abuse. 2023 Apr 6;17:11782218231166809. doi: 10.1177/11782218231166809. eCollection 2023.
- 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 CentreLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John A Cunningham, Ph.D. principal investigator
Centre for Addiction and Mental Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized Feedback and Education in people with Cannabis Use, run by Centre for Addiction and Mental Health at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cannabis Use in the last 30 days (time frame: 3 and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04060602, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2020.