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Cannabinoid

Oral THC and CBD for Substance Use Disorders (O-TACOFS Trial)

Phase 1
Waitlist Available
Led By Ziva Cooper
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
Be between 18 and 65 years old
Must not have
History of respiratory illness or current respiratory illness
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 hours

Summary

This trial will study how the body processes THC and CBD when taken orally, as well as how recently smoked THC can be detected in oral fluid.

Who is the study for?
This trial is for men and women aged 21-55 who use cannabis weekly or monthly but aren't seeking treatment for it. They must have a BMI of 18.5 - 34kg/m2, be able to do all study tasks, and use contraception. People can't join if they're on meds that affect the study, have significant illnesses, are pregnant or breastfeeding, have respiratory issues, are in another study, don’t use contraception, have severe Cannabis Use Disorder or other substance disorders.
What is being tested?
The trial is testing how oral THC (the psychoactive component of cannabis), CBD (a non-psychoactive component), their combination, and a placebo affect individuals. It looks at how these substances move through and act in the body and whether recent smoking can be detected in saliva.
What are the potential side effects?
Possible side effects from THC could include dry mouth, red eyes, memory impairment while under influence; CBD might cause fatigue or changes in appetite. Side effects vary by individual.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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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:
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I have or had a lung or breathing problem.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 hours for reporting.

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
Concentration of THC in oral fluid
Concentration of THC, CBD and metabolites in whole blood
+1 more

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: 20 mg THC + 20 mg CBDExperimental Treatment1 Intervention
THC and CBD in sesame and MCT oil
Group II: 20 mg THCExperimental Treatment1 Intervention
THC suspended in sesame oil
Group III: 20 mg CBDExperimental Treatment1 Intervention
CBD suspended in MCT oil
Group IV: PlaceboPlacebo Group1 Intervention
Oral placebo; sesame and MCT oil
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
THC
2017
Completed Phase 1
~440
CBD
2016
Completed Phase 2
~530

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
1,567 Previous Clinical Trials
10,266,978 Total Patients Enrolled
12 Trials studying Substance Abuse
5,590 Patients Enrolled for Substance Abuse
Ziva CooperPrincipal InvestigatorUniversity of California, Los Angeles

Media Library

CBD (Cannabinoid) Clinical Trial Eligibility Overview. Trial Name: NCT05067387 — Phase 1
Substance Abuse Research Study Groups: Placebo, 20 mg THC, 20 mg CBD, 20 mg THC + 20 mg CBD
Substance Abuse Clinical Trial 2023: CBD Highlights & Side Effects. Trial Name: NCT05067387 — Phase 1
CBD (Cannabinoid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05067387 — Phase 1
~4 spots leftby Mar 2025
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