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Intensive Day Monitoring for Cannabis Use (CLR2 Trial)
N/A
Recruiting
Led By Stephanie Wemm, PhD
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 days
Awards & highlights
CLR2 Trial Summary
This trial looks at how cannabis use affects the brain, and if that affects cravings, in response to cues and stress.
Who is the study for?
This trial is for adults over 18 who use cannabis at least once a week and have done so in the past year. They should only have mild Cannabis and Alcohol Use Disorders, if any, be fluent in English, able to consent to the study, and test negative for alcohol but positive for cannabis.Check my eligibility
What is being tested?
The study is testing 'Intensive Day Monitoring' methods to understand how heavy cannabis use affects the body and whether these changes can predict intense cravings when exposed to stress or reminders of cannabis.See study design
What are the potential side effects?
Since this trial involves monitoring rather than medication or medical procedures, traditional side effects are not expected. However, participants may experience psychological discomfort from discussing their substance use habits.
CLR2 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 48 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Averaged cortisol response to stress and cannabis cues in the real world
Ratings of subjective craving in the real world
Ratings of subjective subjective stress in the real world
Secondary outcome measures
Self-reported cannabis use
CLR2 Trial Design
1Treatment groups
Experimental Treatment
Group I: Individuals who use cannabisExperimental Treatment1 Intervention
Participants who are non-treatment seeking cannabis users (30 men, 30 women) ranging from once weekly use to multiple times daily. All participants will be recruited from the greater New Haven community and will complete four weeks of smartphone monitoring. During this monitoring period, they will also complete two three-consecutive days of intensive monitoring including more frequent smartphone surveys, saliva samples, heart rate monitoring, and an alcohol use monitor.
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Who is running the clinical trial?
Yale UniversityLead Sponsor
1,853 Previous Clinical Trials
2,738,501 Total Patients Enrolled
14 Trials studying Cannabis
764 Patients Enrolled for Cannabis
Robert E. Leet and Clara Guthrie Patterson Trust Mentored Research AwardUNKNOWN
Stephanie Wemm, PhDPrincipal InvestigatorAssociate Research Scientist, Psychiatry
2 Previous Clinical Trials
93 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any major health issues that need medication.I am not taking medication that affects my hormone control system.I use cannabis and can sign a consent form.I am pregnant, breastfeeding, going through menopause, or have had a hysterectomy.I am not currently using any psychotropic drugs except for antidepressants.I use cannabis and speak English fluently.I use cannabis at least once a week.I use cannabis but don't have a severe addiction to it or any other substance except mild alcohol use.I am 18 or older and use cannabis.
Research Study Groups:
This trial has the following groups:- Group 1: Individuals who use cannabis
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this experiment currently accepting applicants?
"According to the data on clinicaltrials.gov, this medical trial is not taking in patients at present; it was first made available on May 1st 2023 and last amended April 14th 2023. Nevertheless, there are 134 other research trials that are currently searching for participants."
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