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Cannabinoid
Smoked Cannabis Effects Study (S-TACOFS Trial)
Phase 1
Recruiting
Led By Ziva Cooper, PhD
Research Sponsored by University of California, Los Angeles
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male or non-pregnant and non-lactating females aged 21-55 years
Male or non-pregnant and non-lactating females aged 21-55 years
Must not have
History of respiratory illness or current respiratory illness
Timeline
Screening 2 days
Treatment 1 month
Follow Up 0 days
Summary
This trial will study how different doses of inhaled cannabis with varying amounts of THC and CBD affects the body, as well as how long THC can be detected in oral fluid.
Who is the study for?
This trial is for men and women aged 21-55 who are not pregnant or breastfeeding, with a BMI of 18.5-34kg/m2, use cannabis weekly to monthly without seeking treatment, and agree to use contraception. Excluded are those with significant illness, other substance abuse disorders besides nicotine/caffeine, current heavy medication users, or those with respiratory issues.
What is being tested?
The study tests the effects of inhaled cannabis by comparing placebo (no THC/CBD), just THC (20 mg), just CBD (20 mg), and a combination of THC and CBD (20 mg each). It aims to understand how these substances affect the body and how they can be detected in oral fluid after smoking.
What are the potential side effects?
Potential side effects may include altered mental state due to THC intoxication, dizziness, dry mouth, changes in appetite or mood swings from both THC and CBD. Side effects vary based on individual tolerance levels.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a man or a woman not pregnant or breastfeeding, aged 21-55.
Select...
I am a man or a woman not pregnant or breastfeeding, aged 21-55.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have or had a lung or breathing problem.
Timeline
Screening ~ 2 days2 visits
Treatment ~ 1 month4 visits
Follow Up ~ 0 days0 visits
Screening ~ 2 days
Treatment ~ 1 month
Follow Up ~0 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Behavioral task performance as assessed by the DRUID App Score
Pharmacokinetics of THC, CBD and metabolites
Subjective drug effect ratings of impairment and abuse liability
+1 moreSide effects data
From 2019 Phase 4 trial • 46 Patients • NCT0300800513%
Nausea and Dizziness
100%
80%
60%
40%
20%
0%
Study treatment Arm
Dronabinol Cap 5 Milligrams (MG)
Placebo Oral Capsule
Dronabinol Cap 10 Milligrams (MG)
Trial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: 20 mg THCExperimental Treatment1 Intervention
Smoked cannabis with THC
Group II: 20 mg CBD + 20 mg THCExperimental Treatment1 Intervention
Smoked cannabis with CBD and THC
Group III: 20 mg CBDExperimental Treatment1 Intervention
Smoked cannabis with CBD
Group IV: PlaceboPlacebo Group1 Intervention
Smoked placebo cannabis
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
University of California, Los AngelesLead Sponsor
1,564 Previous Clinical Trials
10,262,611 Total Patients Enrolled
12 Trials studying Substance Abuse
5,590 Patients Enrolled for Substance Abuse
Ziva Cooper, PhDPrincipal InvestigatorUniversity of California, Los Angeles
4 Previous Clinical Trials
375 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- If you have a Body Mass Index (BMI) between 18.5 and 34 kg/m2, you are considered to be within the healthy weight range.My doctor has checked my health history and found no issues with using cannabis.I take medication daily or weekly, not including birth control.I have used cannabis once a week or less in the past month.You have a moderate to severe addiction to marijuana or any other drugs except nicotine and caffeine, according to the DSM-V criteria.You have used illegal drugs, except for cannabis, in the last 4 weeks.I am not taking any medications that could interfere with the study.I have or had a lung or breathing problem.I can attend the study in Westwood (Los Angeles) between 9 AM - 4 PM on weekdays.I have a chronic condition like pain, anxiety, depression, or diabetes.I am a man or a woman not pregnant or breastfeeding, aged 21-55.I can participate in all required study activities.I am a man or a woman not pregnant or breastfeeding, aged 21-55.You have any other mental health condition.You are not getting treatment for your use of cannabis.You are not currently receiving treatment for using cannabis.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: 20 mg THC
- Group 3: 20 mg CBD + 20 mg THC
- Group 4: 20 mg CBD
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 2 Weeks to process to see if you qualify in this trial.
- Treatment: You will receive the treatment for 1 Months
- Follow Ups: You may be asked to continue sharing information regarding the trial for 0 Months after you stop receiving the treatment.
Substance Abuse Patient Testimony for trial: Trial Name: NCT05037487 — Phase 1
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