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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 hours
Awards & highlights

O-TACOFS Trial 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.Check my eligibility
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.See study design
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.

O-TACOFS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a man or a woman not pregnant or breastfeeding, aged 21-55.

O-TACOFS Trial 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

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

O-TACOFS 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
~330
CBD
2016
Completed Phase 2
~440

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
1,529 Previous Clinical Trials
10,277,780 Total Patients Enrolled
19 Trials studying Substance Abuse
6,011 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What other kinds of tests have been conducted with THC as the focus?

"At present, 104 studies researching THC are currently running with 19 of them in the 3rd Phase. Most trials for this compound are located around Belmont, MA but a total of 331 medical institutions have clinical trial programs related to THC."

Answered by AI

Has the Food and Drug Administration sanctioned THC for any medical purposes?

"As this is an early-stage trial, the safety of THC has been rated at 1 due to a lack of data confirming efficacy and limited information on its potential hazards."

Answered by AI

Are additional participants being enrolled in this experiment?

"As indicated on the clinicaltrials.gov website, this research is no longer accepting applicants despite being initially posted back in August 1st 2022 and most recently updated on June 8th 2022. Fortunately, there are 462 alternative studies actively searching for candidates to join their trial at present time."

Answered by AI

What conditions is tetrahydrocannabinol typically prescribed to alleviate?

"When traditional therapy fails to yield satisfactory results, THC can often serve as a viable alternative. This chemical compound has also proven effective in treating various other issues such as multiple sclerosis, pharmacotherapy and pain management."

Answered by AI

How many participants are being included in the experiment?

"Recruitment for this trial is currently on hiatus. The clinical study was first posted on August 1st 2022 and last updated June 8th 2022. If you are in search of alternative trials, there exist 358 studies actively enrolling patients with substance abuse disorders and 104 involving THC that need participants."

Answered by AI

Does this trial accommodate participants over the age of 50?

"The study is seeking individuals between the ages of 21 and 55 to take part in this clinical trial."

Answered by AI

Is it possible for me to join this research trial?

"This medical experiment is looking for 22 people with substance use disorders between the ages of 21 and 55. To be eligible to participate, individuals must not already be undergoing cannabis treatment, possess a Body Mass Index ranging from 18.5 - 34kg/m2., and meet gender requirements (male or non-pregnant female)."

Answered by AI

Who else is applying?

What state do they live in?
California
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
University of California, Los Angeles
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I wanted to gain more insight in my routine of substance abuse and this trial caught my attention and I feel like I’m a great fit to do research on.
PatientReceived 2+ prior treatments

How responsive is this trial?

Most responsive sites:
  1. University of California, Los Angeles: < 48 hours
Average response time
  • < 2 Days
Typically responds via
Email
Recent research and studies
clinicaltrials.govStudy
Evaluation of Oral THC and CBD in Men and Women
Ziva D. Cooper, PhD 2024. "Evaluation of Oral THC and CBD in Men and Women". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05067387.
All > Substance Abuse > Cannabis
~15 spots leftby Mar 2025
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