Cannabis UseNCT05382273
Cannabis Tolerance Break Resource Study: T-Break Guide
An observational study of Cannabis Use and Tolerance, run by University of Vermont at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cannabis Use, Tolerance, Cannabis Withdrawal
- What is being tested?
- T-Break Guide
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 151 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Apr 2021to 1 Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Current cannabis partakers, willing to attempt at 21 day tolerance break (ie, period of cannabis abstinence)
Who cannot join
- No cannabis use in past month
Trial locations and contacts
1 site in 1 country.
About this study
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:
- How did participants use the Guide? (Eg: daily; read once; 'a la carte')
- How did using the Guide increase fidelity to tolerance break (starting, continuing, completing a break)?
- Did using the Guide yield any benefits beyond tolerance break fidelity? (Eg: insight into patterns of use)
Read the 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).
- Conditions
- Cannabis Use, Tolerance, Cannabis Withdrawal
- Being tested
- T-Break Guide
- Keywords
- Open Pilot Study, Pre test / Post test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T-Break GuideBehavioural
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 group | Role | What they receive |
|---|---|---|
| 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" Receives: Behavioral: T-Break Guide | |
| Use of T-Break Guide: A lot | Participants who reported using the T-Break Guide "a lot" Receives: Behavioral: T-Break Guide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerance Break Completion
Did the participant go 21 days without using cannabis? Self-report, "yes/no" question on followup survey
Measured: 21 days
Secondary outcomes (5)
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
Measured: 21 days
Confidence in Future Break
Participants' confidence level about how successful they would be taking a future break
Measured: 30 days
Important of Balance
Participants' importance with finding/keeping balance in cannabis use going forward
Measured: 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
Measured: 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}
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2022
- Study start22 Apr 2021
- Primary completion1 Jul 2021
- Study completion1 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cannabis UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Vermont
- Sponsor type
- University, hospital or other
- Collaborators
- Dartmouth College, Rutgers University
- Responsible party
- Principal investigator, Tom Fontana, University of Vermont
- Investigators
- Tom Fontana, MS, Principal investigator, University of Vermont
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05382273
- Sponsor's protocol ID
- STUDY00001489
- Other IDs
- 03420-08153
- Status last verified
- May 2022
- First submitted
- 11 May 2022
- Last updated
- 19 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Non identifiable participant data is planned to be shared via a free data repository
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.
PubMed 32200158Enkema 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.
PubMed 33383565Schuster 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.
PubMed 30408351
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cannabis Tolerance Break Resource Study: T-Break Guide
- ClinicalTrials.gov ID
- NCT05382273
- Acronym / sponsor ID
- STUDY00001489
- Conditions
- Cannabis Use, Tolerance, Cannabis Withdrawal
- Keywords
- Open Pilot Study, Pre test / Post test
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- University of VermontUniversity, hospital or other
- Collaborators
- Dartmouth College, Rutgers University
- Study start
- 22 Apr 2021 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Aug 2021 (actual)
- First posted
- 19 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- How did participants use the Guide? (Eg: daily; read once; 'a la carte')
- How did using the Guide increase fidelity to tolerance break (starting, continuing, completing a break)?
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Use of T-Break Guide: None | – | –Participants who reported not using the T-Break Guide (intervention) |
| Use of T-Break Guide: Some | – | Behavioral: T-Break GuideParticipants who reported using the T-Break Guide "some" |
| Use of T-Break Guide: A lot | – | Behavioral: T-Break GuideParticipants who reported using the T-Break Guide "a lot" |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Current cannabis partakers, willing to attempt at 21 day tolerance break (ie, period of cannabis abstinence)
Key exclusion criteria (1 listed)
- No cannabis use in past month
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| T-Break GuideThe 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. | Behavioural | Use of T-Break Guide: A lot, Use of T-Break Guide: Some |
Primary outcome
Tolerance Break Completion
Time frame: 21 days
Did the participant go 21 days without using cannabis? Self-report, "yes/no" question on followup survey
5 secondary outcomes
Cannabis Use After 21 Days
Time frame: 21 days
Confidence in Future Break
Time frame: 30 days
Important of Balance
Time frame: 30 days
Alcohol and Other Drug Use During Break
Time frame: 30 days
Future Cannabis Use
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2022.
- Background: PubMed 32200158Enkema 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.
- Background: PubMed 33383565Enkema 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.
- Background: PubMed 30408351Schuster 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.
- Individual participant dataSharing planned: Yes. Non identifiable participant data is planned to be shared via a free data repository
Related trials for Cannabis Use
RecruitingPhase 3
Efficacy of PP-01 in Mitigating Cannabis Withdrawal Symptoms in Adults With Cannabis Use Disorder
Cannabis Withdrawal
Active, not recruitingObservational study
Cannabis Use and Outcomes in Black and White Patients With Cancer
Cancer
Recruiting
MATAspire: Mental Health Awareness Tailored App for Substance Prevention and Integrated Resilience Education
Alcohol Use, Cannabis Use
RecruitingObservational study
A Study in Patients Reporting Cannabis Use Followed With an Application-Based Cannabis Journal
Cancer
RecruitingObservational study
Study of an Oral Fluid Testing Approach
Cannabis Use, Cannabis Intoxication
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tom Fontana, MS principal investigator
University of Vermont
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cannabis Use and Tolerance, run by University of Vermont at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tolerance Break Completion (time frame: 21 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05382273, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2022.