Cannabis Tolerance Break Resource Study: T-Break Guide

• ClinicalTrials.gov Identifier: NCT05382273
• Recruitment Status: Completed
• First Posted: May 19, 2022
• Last Update Posted: May 19, 2022
• Sponsor: University of Vermont
• Collaborators: Dartmouth College; Rutgers University
• Information provided by (Responsible Party): Tom Fontana, University of Vermont

Tracking Information

• First Submitted Date: May 11, 2022
• First Posted Date: May 19, 2022
• Last Update Posted Date: May 19, 2022
• Actual Study Start Date: April 22, 2021
• Actual Primary Completion Date: July 1, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 18, 2022)

Tolerance Break Completion [ Time Frame: 21 days ]

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

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: May 18, 2022)

• 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
• Confidence in Future Break [ Time Frame: 30 days ]
  Participants' confidence level about how successful they would be taking a future break
• Important of Balance [ Time Frame: 30 days ]
  Participants' importance with finding/keeping balance in cannabis use going forward
• 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
• 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}

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

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

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).

• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• 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.

Condition

• Cannabis Use
• Tolerance
• Cannabis Withdrawal

Intervention

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.

Study Groups/Cohorts

• 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"
  Intervention: Behavioral: T-Break Guide
• Use of T-Break Guide: A lot
  Participants who reported using the T-Break Guide "a lot"
  Intervention: Behavioral: T-Break Guide

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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 18, 2022): 151
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: August 1, 2021
• Actual Primary Completion Date: July 1, 2021 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05382273
• Other Study ID Numbers: STUDY00001489; 03420-08153 ( Other Grant/Funding Number: State of Vermont - ADAP )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: Non identifiable participant data is planned to be shared via a free data repository
• Access Criteria: Free and open

• Current Responsible Party: Tom Fontana, University of Vermont
• Original Responsible Party: Same as current
• Current Study Sponsor: University of Vermont
• Original Study Sponsor: Same as current

Collaborators

• Dartmouth College
• Rutgers University

Investigators

• Principal Investigator: Tom Fontana, MS; University of Vermont

• PRS Account: University of Vermont
• Verification Date: May 2022