Cannabis Effects as a Function of Sex (CanSex)

Phase 1

Recruiting

• Conditions: Pain; Abuse, Drug
• Interventions: Drug: Active Cannabis; Drug: Placebo Cannabis

• Registration Number: NCT04385082
• Lead Sponsor: 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

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.

Study Timeline

• Study First Submitted: 2020-05-07
• Study First Submitted QC: 2020-05-11
• Study First Posted: 2020-05-12
• Study Start: 2021-07-08
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-15
• Last Update Posted: 2024-05-16
• Primary Completion: 2025-06-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 160

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Higher strength cannabis	Active Cannabis	Smoked Cannabis (\~10% THC)
Placebo	Placebo Cannabis	Smoked Cannabis (\~0% THC)
Low strength cannabis	Active Cannabis	Smoked Cannabis (\~4% THC)

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics of THC and metabolites	5 hours	Plasma levels of THC, 11-OH-THC, and THCCOOH
Subject-rated drug effects	5 hours	Average and peak subjective ratings of drug effects associated with abuse liability as measured using visual analogue scales (VAS; 1-100mm).
Analgesia as measured using the Cold Pressor Test	5 hours	Peak and average pain threshold and tolerance assessed using the Cold Pressor Test

Secondary Outcome Measures

Name	Time	Method
Drug reinforcement using the cannabis self-administration task	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.

Trial Locations

Locations (1)

University of California, Los Angeles; 🇺🇸 Los Angeles, California, United States