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Cannabis Effects as a Function of Sex (CanSex) (CanSex)

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ClinicalTrials.gov Identifier: NCT04385082
Recruitment Status : Recruiting
First Posted : May 12, 2020
Last Update Posted : October 12, 2022
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Ziva D. Cooper, PhD, University of California, Los Angeles

Brief Summary:
The purpose of this research is to assess the impact of cannabis on the analgesic and abuse-related effects between men and women

Condition or disease Intervention/treatment Phase
Pain Abuse, Drug Drug: Active Cannabis Drug: Placebo Cannabis Phase 1

Detailed Description:
The proposed study will compare smoked cannabis's dose-dependent, analgesic and abuse-related effects between men and women and variables that underlie these sex-dependent differences, including pharmacokinetics of THC.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 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: Sex-dependent Effects of Cannabis: Assessing Analgesic, Abuse-related and Pharmacokinetic Differences Between Men and Women
Actual Study Start Date : June 30, 2021
Estimated Primary Completion Date : June 30, 2025
Estimated Study Completion Date : June 30, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana

Arm Intervention/treatment
Placebo Comparator: Placebo
Smoked Cannabis (~0% THC)
Drug: Placebo Cannabis
Placebo smoked cannabis (no THC)

Experimental: Low strength cannabis
Smoked Cannabis (~4% THC)
Drug: Active Cannabis
Smoked cannabis with THC

Experimental: Higher strength cannabis
Smoked Cannabis (~10% THC)
Drug: Active Cannabis
Smoked cannabis with THC




Primary Outcome Measures :
  1. Subject-rated drug effects [ Time Frame: 5 hours ]
    Average and peak subjective ratings of drug effects associated with abuse liability as measured using visual analogue scales (VAS; 1-100mm).

  2. Analgesia as measured using the Cold Pressor Test [ Time Frame: 5 hours ]
    Peak and average pain threshold and tolerance assessed using the Cold Pressor Test

  3. Pharmacokinetics of THC and metabolites [ Time Frame: 5 hours ]
    Plasma levels of THC, 11-OH-THC, and THCCOOH


Secondary Outcome Measures :
  1. Drug reinforcement using the cannabis self-administration task [ Time Frame: 5 hours ]
    Average number of cannabis puffs self-administered as a function of cannabis strength and sex. For this task, up to three 'puffs' of cannabis may be chosen for self-administration during each session.



Information from the National Library of Medicine

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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 female aged 21-55 years
  • Report use of cannabis an average of 1-7 days per week
  • Not currently seeking treatment for their cannabis use
  • Urine test positive for recent cannabis use for heavy users
  • No reported adverse effects with cannabis smoking in light users
  • Have a Body Mass Index from 18.5 - 34kg/m2.
  • Able to perform all study procedures
  • FEMALES: Currently practicing a non-hormonal effective form of birth control
  • FEMALES: Must be regularly cycling

Exclusion Criteria:

  • Meeting DSM-V criteria for any substance use disorder other than nicotine, caffeine, or cannabis use disorder
  • Report using other illicit drugs in the prior 4 weeks
  • History or current evidence of severe psychiatric illness or medical condition judged by the study physician and PI to put the participant at greater risk of experiencing adverse events due to completion of study procedures, interfere with their ability to participate in the study, or their capacity to provide informed consent.
  • Current use of medical cannabis, prescription analgesics, or any medications that may affect study outcomes
  • Current pain
  • Insensitivity to the cold water stimulus of the Cold Pressor Test
  • FEMALES: using a hormonal contraceptive

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): NCT04385082


Contacts
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Contact: Ziva Cooper, PhD 310-206-9942 zcooper@mednet.ucla.edu
Contact: Vincent Acebo 310-983-3417 vacebo@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    310-983-3417    vacebo@mednet.ucla.edu   
Principal Investigator: Ziva Cooper, PhD         
Sponsors and Collaborators
University of California, Los Angeles
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Ziva Cooper, PhD University of California, Los Angeles
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Responsible Party: Ziva D. Cooper, PhD, Associate Professor, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT04385082    
Other Study ID Numbers: 19-000876
R01DA047296 ( U.S. NIH Grant/Contract )
First Posted: May 12, 2020    Key Record Dates
Last Update Posted: October 12, 2022
Last Verified: October 2022
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:
Pain
Cannabis
THC
Additional relevant MeSH terms:
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Marijuana Abuse
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders