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Cannabis Tolerance Break Resource Study: T-Break Guide

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ClinicalTrials.gov Identifier: NCT05382273
Recruitment Status : Completed
First Posted : May 19, 2022
Last Update Posted : May 19, 2022
Sponsor:
Collaborators:
Dartmouth College
Rutgers University
Information provided by (Responsible Party):
Tom Fontana, University of Vermont

Study Description
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Brief Summary:

The purpose of this pilot study is to conduct research into the value of using the T-Break Guide for assisting people taking a tolerance break from cannabis. The hope is that this initial research will yield some insights and benchmarks into the Guide's efficacy, and provide a foundation for a later randomized control study.

The following are some key research questions:

  1. How did participants use the Guide? (Eg: daily; read once; 'a la carte')
  2. How did using the Guide increase fidelity to tolerance break (starting, continuing, completing a break)?
  3. Did using the Guide yield any benefits beyond tolerance break fidelity? (Eg: insight into patterns of use)

Condition or disease Intervention/treatment
Cannabis Use Tolerance Cannabis Withdrawal Behavioral: T-Break Guide

Detailed Description:

The pilot study used a pretest-posttest design in which participants completed a baseline survey and were asked to attempt a 21-day period of cannabis abstinence, to consider using the T-Break Guide (intervention) in their attempt, and to complete a follow-up survey after 30 days.

Participants were young adults aged 18-29 recruited through posters and tabling events at the University of Vermont (UVM), a post on a UVM webpage, emails on listservs of seven other universities, and a post on a subreddit focusing on responsible cannabis use. The posters and online announcements directed participants to the online baseline survey, which contained consent information before allowing participants to complete.

After completing the baseline survey, participants received a link to an online version of the T-Break Guide through email. After 30 days, participants received another email prompting them to complete the follow-up survey. The UVM Institutional Review Board reviewed and approved all study procedures (STUDY00001489).

Study Design
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Study Type : Observational
Actual Enrollment : 151 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cannabis Tolerance Break Resource Study: T-Break Guide
Actual Study Start Date : April 22, 2021
Actual Primary Completion Date : July 1, 2021
Actual Study Completion Date : August 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana

Groups and Cohorts
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Group/Cohort Intervention/treatment
Use of T-Break Guide: None
Participants who reported not using the T-Break Guide (intervention)
Use of T-Break Guide: Some
Participants who reported using the T-Break Guide "some"
 Behavioral: T-Break Guide

The T-Break Guide was designed to help people complete a 21-day break from cannabis. For each day of the break, the Guide offers inspiration in the form of a quote, reflections based on likely experiences occurring at that point during the break, advice on ways to overcome challenges, alternative activities in which to engage, and encouragement.

  • The first week focuses on physical symptoms of cannabis withdrawal (e.g., sleep, appetite).
  • The second week focuses on the emotional experience (e.g., anxiety, boredom).
  • The third week focuses on behavioral aspects (e.g., examining patterns, connections).

The T-Break Guide follows the Motivational Interviewing principles of affirmation and autonomy.
Use of T-Break Guide: A lot
Participants who reported using the T-Break Guide "a lot"
 Behavioral: T-Break Guide

The T-Break Guide was designed to help people complete a 21-day break from cannabis. For each day of the break, the Guide offers inspiration in the form of a quote, reflections based on likely experiences occurring at that point during the break, advice on ways to overcome challenges, alternative activities in which to engage, and encouragement.

  • The first week focuses on physical symptoms of cannabis withdrawal (e.g., sleep, appetite).
  • The second week focuses on the emotional experience (e.g., anxiety, boredom).
  • The third week focuses on behavioral aspects (e.g., examining patterns, connections).

The T-Break Guide follows the Motivational Interviewing principles of affirmation and autonomy.


Outcome Measures
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Primary Outcome Measures :
  1. Tolerance Break Completion [ Time Frame: 21 days ]
    Did the participant go 21 days without using cannabis? Self-report, "yes/no" question on followup survey


Secondary Outcome Measures :
  1. Cannabis Use After 21 Days [ Time Frame: 21 days ]
    How much cannabis are participants using after 21 days break? Followup survey question, 5 point Likert scale with "way more; a little more; same; a little less; way less" as response options

  2. Confidence in Future Break [ Time Frame: 30 days ]
    Participants' confidence level about how successful they would be taking a future break

  3. Important of Balance [ Time Frame: 30 days ]
    Participants' importance with finding/keeping balance in cannabis use going forward

  4. Alcohol and Other Drug Use During Break [ Time Frame: 30 days ]
    What happened to participants' alcohol and other drug use while stopping cannabis? Self report by category of substance, asking use prior and change (if any) during break

  5. Future Cannabis Use [ Time Frame: 30 days ]
    After taking a break, where do participants' picture their cannabis use in 3 years? Followup survey question, "Where do you picture your cannabis use 3 years from now" {"a lot more; a little more; about the same; a little less; a lot less; none}


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Participants were young adults aged 18-29 recruited through posters and tabling events at the University of Vermont (UVM), a post on a UVM webpage, emails on listservs of seven other universities, and a post on a subreddit focusing on responsible cannabis use. The posters and online announcements directed participants to the online baseline survey, which contained consent information before allowing participants to complete.
Criteria

Inclusion Criteria:

  • Current cannabis partakers, willing to attempt at 21 day tolerance break (ie, period of cannabis abstinence)

Exclusion Criteria:

  • No cannabis use in past month
Contacts and Locations
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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): NCT05382273


Locations
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United States, Vermont
University of Vermont
Burlington, Vermont, United States, 05405
Sponsors and Collaborators
University of Vermont
Dartmouth College
Rutgers University
Investigators
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Principal Investigator: Tom Fontana, MS University of Vermont
More Information
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Publications:

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Responsible Party: Tom Fontana, Alcohol, Cannabis & Other Drugs Initiatives Manager, University of Vermont
ClinicalTrials.gov Identifier: NCT05382273    
Other Study ID Numbers: STUDY00001489
03420-08153 ( Other Grant/Funding Number: State of Vermont - ADAP )
First Posted: May 19, 2022    Key Record Dates
Last Update Posted: May 19, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Non identifiable participant data is planned to be shared via a free data repository
Access Criteria: Free and open

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tom Fontana, University of Vermont:
Open Pilot Study
Pre test / Post test
Additional relevant MeSH terms:
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Marijuana Abuse
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders