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Completed

NCT Number: NCT05382273

Cannabis Tolerance Break Resource Study: T-Break Guide

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)

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Key information

Conditions

Cannabis Use Cannabis Withdrawal Tolerance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Vermont

Burlington, Vermont, 05405, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

T-Break Guide

Behavioral

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.

Primary outcomes

  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 outcomes

  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}

Sponsors and collaborators

Lead sponsor

University of Vermont

Other

Collaborators

  • Dartmouth College
  • Rutgers University

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
May 19, 2022
Registry last updated
May 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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