Your session is about to expire
← Back to Search
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
Timeline
Screening 2 days
Treatment 1 months
Follow Up 6 hour
Awards & highlights
S-TACOFS Trial 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.Check my eligibility
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.See study design
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.
S-TACOFS Trial 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.
S-TACOFS Trial Timeline
Screening ~ 2 days2 visits
Treatment ~ 1 months4 visits
Follow Up ~ 6 hour
Screening ~ 2 days
Treatment ~ 1 months
Follow Up ~6 hour
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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)
S-TACOFS 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
1,530 Previous Clinical Trials
10,264,665 Total Patients Enrolled
19 Trials studying Substance Abuse
6,011 Patients Enrolled for Substance Abuse
Ziva Cooper, PhDPrincipal InvestigatorUniversity of California, Los Angeles
4 Previous Clinical Trials
375 Total Patients Enrolled
3 Trials studying Substance Abuse
308 Patients Enrolled for Substance Abuse
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
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What medical benefits can be obtained from consuming a combination of 20 mg CBD and 20 mg THC Cannabis?
"A combination of 20 mg CBD and 20 mg THC Cannabis may be prescribed to ameliorate weight loss, inadequate response to conventional therapy, and pharmacotherapy."
Answered by AI
Do I satisfy the requirements to participate in this medical experiment?
"This study requires 22 persons with a history of drug abuse ranging from 21 to 55 years old. Participants should have an BMI between 18.5 and 34kg/m2, not actively seek treatment for cannabis use, and be either male or non-pregnant & non-lactating females."
Answered by AI
Are there any vacancies for participants in this trial?
"According to clinicaltrials.gov, the research team is presently recruiting participants for this study which was published on June 1st 2022 and last updated 8 days later."
Answered by AI
Could you please elucidate the results of any prior investigations involving cannabis that had a dosage combination of 20 mg CBD and 20 mg THC?
"At the present moment, 64 medical studies are actively investigating 20 mg CBD + 20 mg THC Cannabis with 8 trials in Phase 3. Belmont, Massachusetts is one of 132 sites hosting these experiments."
Answered by AI
What is the current patient population for this medical study?
"Affirmative. The clinicaltrial.gov website attests that this medical research, originally posted on June 1st 2022 is actively recruiting participants. 22 individuals are required at a single site to complete the trial."
Answered by AI
Is admission to this investigation restricted to individuals aged 18 or older?
"The criteria for enrolment in this trial dictates that applicants must be aged between 21 and 55."
Answered by AI
Who else is applying?
What state do they live in?
California
How old are they?
18 - 65
What site did they apply to?
University of California, Los Angeles
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
1
3+
0
Why did patients apply to this trial?
It sounds fascinating. I need you to help me help myself 🙏. I started smoking weed during COVID-19.
PatientReceived 2+ prior treatments
I use cannibus and am willing to be apart of your trial. I’m interested in ways of controlling my substance use.
PatientReceived 2+ prior treatments
What questions have other patients asked about this trial?
How long is this study? Do you get paid for these trials? How many days in advance well I know I have to be there?
PatientReceived 1 prior treatment
How responsive is this trial?
Typically responds via
Email
Most responsive sites:
- University of California, Los Angeles: < 24 hours
Average response time
- < 1 Day
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger