Cannabis Effects as a Function of Sex (CanSex)

Pain Clinical Trial

— CanSex  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04385082
• Other study ID #: 19-000876
• Secondary ID: R01DA047296
• Status: Recruiting
• Phase: Phase 1
• Start date: July 8, 2021
• Est. completion date: June 30, 2026

Study information

• Verified date: July 2023
• Source: University of California, Los Angeles
• Contact: Ziva Cooper, PhD
• Phone: 310-206-9942
• Email: zcooper[@]mednet.ucla.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: June 30, 2026
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Abuse, Drug
• Marijuana Abuse
• Pain
• Substance-Related Disorders

Intervention

Drug:
• Active Cannabis
Smoked cannabis with THC
• Placebo Cannabis
Placebo smoked cannabis (no THC)

Locations

Country	Name	City	State
United States	University of California, Los Angeles	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Los Angeles	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subject-rated drug effects	Average and peak subjective ratings of drug effects associated with abuse liability as measured using visual analogue scales (VAS; 1-100mm).	5 hours
Primary	Analgesia as measured using the Cold Pressor Test	Peak and average pain threshold and tolerance assessed using the Cold Pressor Test	5 hours
Primary	Pharmacokinetics of THC and metabolites	Plasma levels of THC, 11-OH-THC, and THCCOOH	5 hours
Secondary	Drug reinforcement using the cannabis self-administration task	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.	5 hours