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)

Study Overview

• Status: Completed
• Conditions: Cannabis Use; Tolerance; Cannabis Withdrawal
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 151

Contacts and Locations

Study Locations

• United States
  • Vermont
    • Burlington, Vermont, United States, 05405
      • University of Vermont

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Vermont
• Collaborators: Dartmouth College; Rutgers University
• Investigators: Principal Investigator: Tom Fontana, MS, University of Vermont

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 22, 2021
• Primary Completion (Actual): July 1, 2021
• Study Completion (Actual): August 1, 2021

Study Registration Dates

• First Submitted: May 11, 2022
• First Submitted That Met QC Criteria: May 18, 2022
• First Posted (Actual): May 19, 2022

Study Record Updates

• Last Update Posted (Actual): May 19, 2022
• Last Update Submitted That Met QC Criteria: May 18, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Open Pilot Study; Pre test / Post test
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Marijuana Abuse
• Other Study ID Numbers: STUDY00001489; 03420-08153 (Other Grant/Funding Number: State of Vermont - ADAP)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Non identifiable participant data is planned to be shared via a free data repository
• IPD Sharing Access Criteria: Free and open

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No