Cannabis Tolerance Break Resource Study: T-Break Guide

NCT05382273 | Completed

• 2 other identifiers: STUDY0000148903420-08153
• Study Type: observational
• Target: 151
• Locations: 1 country
• Sites: 1

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

Conditions

Cannabis Use; Tolerance; Cannabis Withdrawal

Keywords

Open Pilot Study; Pre test / Post test

Outcome Measures

Primary Outcomes (1)

• Tolerance Break Completion

  Did the participant go 21 days without using cannabis? Self-report, "yes/no" question on followup survey

  21 days

Secondary Outcomes (5)

• Cannabis Use After 21 Days

  21 days

• Confidence in Future Break

  30 days

• Important of Balance

  30 days

• Alcohol and Other Drug Use During Break

  30 days

• Future Cannabis Use

  30 days

Study Arms (3)

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

Use of T-Break Guide: A lot

Participants who reported using the T-Break Guide "a lot"

Behavioral: T-Break Guide

Interventions

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.

Use of T-Break Guide: A lot; Use of T-Break Guide: Some

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• No cannabis use in past month

Sponsors & Collaborators

• University of Vermont: lead
• Dartmouth College: collaborator
• Rutgers University: collaborator

Study Sites (1)

University of Vermont

Burlington, Vermont, 05405, United States

Location

Related Publications (3)

• 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.

  PMID: 32200158 BACKGROUND

• 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.

  PMID: 33383565 BACKGROUND

• 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.

  PMID: 30408351 BACKGROUND

Study Officials

• Tom Fontana, MS

  University of Vermont

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Alcohol, Cannabis & Other Drugs Initiatives Manager

Study Record Dates

• First Submitted: May 11, 2022
• First Posted: May 19, 2022
• Study Start: April 22, 2021
• Primary Completion: July 1, 2021
• Study Completion: August 1, 2021
• Last Updated: May 19, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share
• Access Criteria: Free and open

Locations

US (1)