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Evaluation of Oral THC and CBD in Men and Women (O-TACOFS)

Primary Purpose

Drug Abuse, Intoxication by Drug, Impairment

Status

Not yet recruiting

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Placebo

THC

CBD

THC + CBD

About this trial

This is an interventional basic science trial for Drug Abuse focused on measuring THC, CBD, Intoxication, Impairment

Eligibility Criteria

21 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Male or non-pregnant and non-lactating females aged 21-55 years
Report weekly-monthly use of cannabis (≤1 day per week) over the past month prior to screening,
Not currently seeking treatment for their cannabis use
Have a Body Mass Index from 18.5 - 34kg/m2.
Able to perform all study procedures
Must be using a contraceptive (hormonal or barrier methods)

Exclusion Criteria:

Meeting DSM-V criteria for moderate to severe Cannabis Use disorder (CUD) or any substance use disorder other than nicotine, caffeine
Any other Axis I disorder
Report using other illicit drugs in the prior 4 weeks, other than cannabis.
Current use of any medications that may affect study outcomes
If medical history, physical and psychiatric examination, or laboratory tests performed during the screening process are not within the normal range and / or reveal any significant illness (e.g., hypertension) as judged by the study physician and to put the participant at greater risk of experiencing adverse events due to completion of study procedures.
Pregnancy is exclusionary due to the possible effects of the study medication on fetal development.
History of an allergic reaction or adverse reaction to cannabis is exclusionary.
History of respiratory illness or current respiratory illness
Currently enrolled in another research protocol
Not using a contraceptive method (hormonal or barrier methods)
The evaluating physician reviews all medical assessments along with medical history. Any disorders that might make cannabis administration hazardous are exclusionary.

Sites / Locations

University of California, Los Angeles

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

20 mg THC

20 mg CBD

20 mg THC + 20 mg CBD

Arm Description

Oral placebo; sesame and MCT oil

THC suspended in sesame oil

CBD suspended in MCT oil

THC and CBD in sesame and MCT oil

Outcomes

Primary Outcome Measures

Ratings of subjective drug effects

Average and peak subjective ratings of drug effects associated with abuse liability as measured using visual analogue scales (VAS; 1-100mm).

Concentration of THC, CBD and metabolites in whole blood

Peak blood levels of THC, CBD, 11-OH-THC, and THCCOOH as measured in ng/ml

Behavioral task performance as assessed by the DRUID App Score

Composite score on the DRUID App, a measure of behavioral task performance (range 0-100) where lower scores indicate better performance

Concentration of THC in oral fluid

Liquid chromatography-tandem mass spectrometry

Secondary Outcome Measures

Full Information

NCT ID

NCT05067387

First Posted

September 14, 2021

Last Updated

May 9, 2023

Sponsor

University of California, Los Angeles

1. Study Identification

Unique Protocol Identification Number

NCT05067387

Brief Title

Evaluation of Oral THC and CBD in Men and Women

Acronym

O-TACOFS

Official Title

Evaluation of Oral THC and CBD in Oral Fluid, Pharmacokinetics, and Subjective and Neurocognitive Effects in Men and Women

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

September 2023 (Anticipated)

Primary Completion Date

August 2024 (Anticipated)

Study Completion Date

August 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of California, Los Angeles

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to determine the pharmacokinetics and pharmacodynamics of oral delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD) and to evaluate detection of recently smoked THC in oral fluid.

Detailed Description

This double-blind placebo controlled, within-subject study study will assess testing devices that can measure biochemical markers in oral fluid and neurocognitive-performance markers of recent THC or CBD use. Other pharmacodynamic effects of oral THC or CBD will be determined and the pharmacokinetics of THC, CBD, and respective metabolites will be assessed in whole blood.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Drug Abuse, Intoxication by Drug, Impairment

Keywords

THC, CBD, Intoxication, Impairment

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Model Description

This is a randomized, double-blind, placebo-controlled study. All participants will complete all dose conditions in a randomized order.

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

22 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Oral placebo; sesame and MCT oil

Arm Title

20 mg THC

Arm Type

Experimental

Arm Description

THC suspended in sesame oil

Arm Title

20 mg CBD

Arm Type

Experimental

Arm Description

CBD suspended in MCT oil

Arm Title

20 mg THC + 20 mg CBD

Arm Type

Experimental

Arm Description

THC and CBD in sesame and MCT oil

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Oral placebo

Intervention Type

Drug

Intervention Name(s)

THC

Intervention Description

Oral THC (20 mg)

Intervention Type

Drug

Intervention Name(s)

CBD

Intervention Description

Oral CBD (20 mg)

Intervention Type

Drug

Intervention Name(s)

THC + CBD

Intervention Description

Oral THC (20 mg) + CBD (20 mg)

Primary Outcome Measure Information:

Title

Ratings of subjective drug effects

Description

Average and peak subjective ratings of drug effects associated with abuse liability as measured using visual analogue scales (VAS; 1-100mm).

Time Frame

6 hours

Title

Concentration of THC, CBD and metabolites in whole blood

Description

Peak blood levels of THC, CBD, 11-OH-THC, and THCCOOH as measured in ng/ml

Time Frame

6 hours

Title

Behavioral task performance as assessed by the DRUID App Score

Description

Composite score on the DRUID App, a measure of behavioral task performance (range 0-100) where lower scores indicate better performance

Time Frame

6 hours

Title

Concentration of THC in oral fluid

Description

Liquid chromatography-tandem mass spectrometry

Time Frame

6 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or non-pregnant and non-lactating females aged 21-55 years Report weekly-monthly use of cannabis (≤1 day per week) over the past month prior to screening, Not currently seeking treatment for their cannabis use Have a Body Mass Index from 18.5 - 34kg/m2. Able to perform all study procedures Must be using a contraceptive (hormonal or barrier methods) Exclusion Criteria: Meeting DSM-V criteria for moderate to severe Cannabis Use disorder (CUD) or any substance use disorder other than nicotine, caffeine Any other Axis I disorder Report using other illicit drugs in the prior 4 weeks, other than cannabis. Current use of any medications that may affect study outcomes If medical history, physical and psychiatric examination, or laboratory tests performed during the screening process are not within the normal range and / or reveal any significant illness (e.g., hypertension) as judged by the study physician and to put the participant at greater risk of experiencing adverse events due to completion of study procedures. Pregnancy is exclusionary due to the possible effects of the study medication on fetal development. History of an allergic reaction or adverse reaction to cannabis is exclusionary. History of respiratory illness or current respiratory illness Currently enrolled in another research protocol Not using a contraceptive method (hormonal or barrier methods) The evaluating physician reviews all medical assessments along with medical history. Any disorders that might make cannabis administration hazardous are exclusionary.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ziva Cooper, PhD

Phone

310-206-9942

zcooper@mednet.ucla.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ziva Cooper

Organizational Affiliation

University of California, Los Angeles

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of California, Los Angeles

City

Los Angeles

State/Province

California

ZIP/Postal Code

90095

Country

United States

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ziva Cooper, PhD

Phone

310-206-9942

zcooper@mednet.ucla.edu

First Name & Middle Initial & Last Name & Degree

Vince Acebo

Phone

310-983-3417

vacebo@mednet.ucla.edu

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Evaluation of Oral THC and CBD in Men and Women

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