Pain Clinical Trial
— CanSexOfficial title:
Sex-dependent Effects of Cannabis: Assessing Analgesic, Abuse-related and Pharmacokinetic Differences Between Men and Women
The purpose of this research is to assess the impact of cannabis on the analgesic and abuse-related effects between men and women
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 |
Country | Name | City | State |
---|---|---|---|
United States | University of California, Los Angeles | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
University of California, Los Angeles | National Institute on Drug Abuse (NIDA) |
United States,
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 |
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