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Evaluation of Smoked THC and CBD in Men and Women (S-TACOFS)

Primary Purpose

Drug Abuse, Intoxication by Drug, Impairment

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Placebo Cannabis
20 mg CBD Cannabis
20 mg CBD + 20 mg THC Cannabis
20 mg THC Cannabis
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Drug Abuse focused on measuring Cannabis, 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 AngelesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

Placebo

20 mg CBD

20 mg CBD + 20 mg THC

20 mg THC

Arm Description

Smoked placebo cannabis

Smoked cannabis with CBD

Smoked cannabis with CBD and THC

Smoked cannabis with THC

Outcomes

Primary Outcome Measures

Subjective drug effect ratings of impairment and abuse liability
Peak subjective ratings of drug effects associated with abuse liability and impairment as measured using visual analogue scales (VAS; 1-100mm).
Pharmacokinetics of THC, CBD and metabolites
Peak blood levels of THC, CBD, 11-OH-THC, and THCCOOH after exposure (Tmax)
Behavioral task performance as assessed by the DRUID App Score
Trough composite scores on the DRUID App
THC concentrations in oral fluid
Peak levels of THC in oral fluid after exposure

Secondary Outcome Measures

Full Information

First Posted
August 31, 2021
Last Updated
May 8, 2023
Sponsor
University of California, Los Angeles
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1. Study Identification

Unique Protocol Identification Number
NCT05037487
Brief Title
Evaluation of Smoked THC and CBD in Men and Women
Acronym
S-TACOFS
Official Title
Evaluation of Smoked 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
Recruiting
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
June 2024 (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
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine the pharmacokinetics and pharmacodynamics of inhaled cannabis with varying amounts of 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 cannabis use. Other pharmacodynamic effects of inhaled cannabis with CBD and THC 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
Cannabis, 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
Smoked placebo cannabis
Arm Title
20 mg CBD
Arm Type
Experimental
Arm Description
Smoked cannabis with CBD
Arm Title
20 mg CBD + 20 mg THC
Arm Type
Experimental
Arm Description
Smoked cannabis with CBD and THC
Arm Title
20 mg THC
Arm Type
Experimental
Arm Description
Smoked cannabis with THC
Intervention Type
Drug
Intervention Name(s)
Placebo Cannabis
Intervention Description
Smoked placebo cannabis
Intervention Type
Drug
Intervention Name(s)
20 mg CBD Cannabis
Intervention Description
Smoked cannabis with CBD
Intervention Type
Drug
Intervention Name(s)
20 mg CBD + 20 mg THC Cannabis
Intervention Description
Smoked cannabis with CBD and THC
Intervention Type
Drug
Intervention Name(s)
20 mg THC Cannabis
Intervention Description
Smoked cannabis with THC
Primary Outcome Measure Information:
Title
Subjective drug effect ratings of impairment and abuse liability
Description
Peak subjective ratings of drug effects associated with abuse liability and impairment as measured using visual analogue scales (VAS; 1-100mm).
Time Frame
6 hours
Title
Pharmacokinetics of THC, CBD and metabolites
Description
Peak blood levels of THC, CBD, 11-OH-THC, and THCCOOH after exposure (Tmax)
Time Frame
6 hours
Title
Behavioral task performance as assessed by the DRUID App Score
Description
Trough composite scores on the DRUID App
Time Frame
6 hour
Title
THC concentrations in oral fluid
Description
Peak levels of THC in oral fluid after exposure
Time Frame
6 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
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
Email
zcooper@mednet.ucla.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ziva Cooper, PhD
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
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ziva Cooper, PhD
Phone
310-206-9942
Email
zcooper@mednet.ucla.edu
First Name & Middle Initial & Last Name & Degree
Vincent Acebo, PhD
Phone
310-983-3417
Email
vacebo@mednet.ucla.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Evaluation of Smoked THC and CBD in Men and Women

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