Sex-dependent Effects of Cannabis: Assessing Analgesic, Abuse-related and Pharmacokinetic Differences Between Men and Women
Overview
- Phase
- Phase 1
- Intervention
- Placebo Cannabis
- Conditions
- Pain
- Sponsor
- University of California, Los Angeles
- Enrollment
- 160
- Locations
- 1
- Primary Endpoint
- Pharmacokinetics of THC and metabolites
- Status
- Recruiting
- Last Updated
- last month
Overview
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.
Investigators
Ziva D. Cooper, PhD
Associate Professor
University of California, Los Angeles
Eligibility 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/m
- •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
Arms & Interventions
Placebo
Smoked Cannabis (\~0% THC)
Intervention: Placebo Cannabis
Low strength cannabis
Smoked Cannabis (\~4% THC)
Intervention: Active Cannabis
Higher strength cannabis
Smoked Cannabis (\~10% THC)
Intervention: Active Cannabis
Outcomes
Primary Outcomes
Pharmacokinetics of THC and metabolites
Time Frame: 5 hours
Plasma levels of THC, 11-OH-THC, and THCCOOH
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).
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
Secondary Outcomes
- Drug reinforcement using the cannabis self-administration task(5 hours)