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OpenTrials
Active, Not Recruiting

NCT Number: NCT04385082

Cannabis Effects as a Function of Sex

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

21 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of California, Los Angeles

Los Angeles, California, 90095, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Active Cannabis

Drug

Smoked cannabis with THC

Placebo cannabis

Drug

Placebo smoked cannabis (no THC)

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Sex-dependent Effects of Cannabis: Assessing Analgesic, Abuse-related and Pharmacokinetic Differences Between Men and Women

Acronym: CanSex

Important dates

Study start
2021
Primary completion
2026
Study completion
2027
First posted
May 12, 2020
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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