Cannabis Tolerance Break Resource Study: T-Break Guide

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

Detailed Description
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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).

Official Title
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Cannabis Tolerance Break Resource Study: T-Break Guide

Conditions
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Cannabis Use, Tolerance, Cannabis Withdrawal

Intervention / Treatment
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* Behavioral: T-Break Guide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Use of T-Break Guide: None<br>Participants who reported not using the T-Break Guide (intervention) | |
| Use of T-Break Guide: Some<br>Participants who reported using the T-Break Guide some | Behavioral: T-Break Guide<br>* 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.<br>|
| Use of T-Break Guide: A lot<br>Participants who reported using the T-Break Guide a lot | Behavioral: T-Break Guide<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerance Break Completion | Did the participant go 21 days without using cannabis? Self-report, yes/no question on followup survey | 21 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cannabis Use After 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 | 21 days | 
| Confidence in Future Break | Participants' confidence level about how successful they would be taking a future break | 30 days | 
| Important of Balance | Participants' importance with finding/keeping balance in cannabis use going forward | 30 days | 
| Alcohol and Other Drug Use During Break | 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 | 30 days | 
| Future Cannabis Use | 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} | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Open Pilot Study, Pre test / Post test