Clinical trial NCT05382273: Cannabis Tolerance Break Resource Study: T-Break Guide
Official title: Cannabis Tolerance Break Resource Study: T-Break Guide
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cannabis Use
Tolerance
Cannabis Withdrawal
Keywords: Open Pilot Study
Pre test / Post test
Lead sponsor: University of Vermont
Sponsor class: OTHER
Collaborators: name: Dartmouth College
name: Rutgers University
First posted: 2022-05-19
Enrollment: 151
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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)

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).

Eligibility 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

Primary outcomes:
measure: Tolerance Break Completion
timeFrame: 21 days
Secondary outcomes:
measure: Cannabis Use After 21 Days
timeFrame: 21 days
measure: Confidence in Future Break
timeFrame: 30 days
measure: Important of Balance
timeFrame: 30 days
measure: Alcohol and Other Drug Use During Break
timeFrame: 30 days
measure: Future Cannabis Use
timeFrame: 30 days
Other outcomes:
Locations:
city: Burlington
country: United States
facility: University of Vermont
state: Vermont
Study officials:
affiliation: University of Vermont
name: Tom Fontana, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Enkema MC, Hallgren KA, Larimer ME. Craving is impermanent and it matters: Investigating craving and cannabis use among young adults with problematic use interested in reducing use. Drug Alcohol Depend. 2020 May 1;210:107957. doi: 10.1016/j.drugalcdep.2020.107957. Epub 2020 Mar 14.
citation: Enkema MC, Hallgren KA, Bowen S, Lee CM, Larimer ME. Craving management: Exploring factors that influence momentary craving-related risk of cannabis use among young adults. Addict Behav. 2021 Apr;115:106750. doi: 10.1016/j.addbeh.2020.106750. Epub 2020 Dec 3.
citation: Schuster RM, Gilman J, Schoenfeld D, Evenden J, Hareli M, Ulysse C, Nip E, Hanly A, Zhang H, Evins AE. One Month of Cannabis Abstinence in Adolescents and Young Adults Is Associated With Improved Memory. J Clin Psychiatry. 2018 Oct 30;79(6):17m11977. doi: 10.4088/JCP.17m11977.