We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Cannabis Tolerance Break Resource Study: T-Break Guide

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05382273
Recruitment Status : Completed
First Posted : May 19, 2022
Last Update Posted : May 19, 2022
Sponsor:
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 *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
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
Removed Location Countries  
 
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