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

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ClinicalTrials.gov Identifier: NCT05037487
Recruitment Status : Recruiting
First Posted : September 8, 2021
Last Update Posted : June 13, 2022
Sponsor:
Information provided by (Responsible Party):
Ziva D. Cooper, PhD, University of California, Los Angeles

Study Description
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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.

Condition or disease Intervention/treatment Phase
Drug Abuse Intoxication by Drug Impairment Drug: Placebo Cannabis Drug: 20 mg CBD Cannabis Drug: 20 mg CBD + 20 mg THC Cannabis Drug: 20 mg THC Cannabis Phase 1

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: This is a randomized, double-blind, placebo-controlled study. All participants will complete all dose conditions in a randomized order.
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Evaluation of Smoked THC and CBD in Oral Fluid, Pharmacokinetics, and Subjective and Neurocognitive Effects in Men and Women
Estimated Study Start Date : June 2022
Estimated Primary Completion Date : November 2023
Estimated Study Completion Date : November 2024
Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo
Smoked placebo cannabis
 Drug: Placebo Cannabis
Smoked placebo cannabis
Experimental: 20 mg CBD
Smoked cannabis with CBD
 Drug: 20 mg CBD Cannabis
Smoked cannabis with CBD
Experimental: 20 mg CBD + 20 mg THC
Smoked cannabis with CBD and THC
 Drug: 20 mg CBD + 20 mg THC Cannabis
Smoked cannabis with CBD and THC
Experimental: 20 mg THC
Smoked cannabis with THC
 Drug: 20 mg THC Cannabis
Smoked cannabis with THC


Outcome Measures
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Primary Outcome Measures :
  1. Subjective drug effect ratings of impairment and abuse liability [ Time Frame: 6 hours ]
    Peak subjective ratings of drug effects associated with abuse liability and impairment as measured using visual analogue scales (VAS; 1-100mm).

  2. Pharmacokinetics of THC, CBD and metabolites [ Time Frame: 6 hours ]
    Peak blood levels of THC, CBD, 11-OH-THC, and THCCOOH after exposure (Tmax)

  3. Behavioral task performance as assessed by the DRUID App Score [ Time Frame: 6 hour ]
    Trough composite scores on the DRUID App

  4. THC concentrations in oral fluid [ Time Frame: 6 hour ]
    Peak levels of THC in oral fluid after exposure


Eligibility Criteria
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Ages Eligible for Study:   21 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05037487


Contacts
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Contact: Ziva Cooper, PhD 310-206-9942 zcooper@mednet.ucla.edu

Locations
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United States, California
University of California, Los Angeles Recruiting
Los Angeles, California, United States, 90095
Contact: Ziva Cooper, PhD    310-206-9942    zcooper@mednet.ucla.edu   
Contact: Vincent Acebo, PhD    310-983-3417    vacebo@mednet.ucla.edu   
Sponsors and Collaborators
University of California, Los Angeles
Investigators
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Principal Investigator: Ziva Cooper, PhD University of California, Los Angeles
More Information
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Responsible Party: Ziva D. Cooper, PhD, Associate Professor, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT05037487    
Other Study ID Numbers: 21-001137
First Posted: September 8, 2021    Key Record Dates
Last Update Posted: June 13, 2022
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ziva D. Cooper, PhD, University of California, Los Angeles:
Cannabis
THC
CBD
Intoxication
Impairment
Additional relevant MeSH terms:
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Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Dronabinol
Hallucinogens
Physiological Effects of Drugs
Psychotropic Drugs
Analgesics, Non-Narcotic
Analgesics
 Sensory System Agents
Peripheral Nervous System Agents
Cannabinoid Receptor Agonists
Cannabinoid Receptor Modulators
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists