Effects of cannabis on pain and abuse in men and women
Sex-dependent Effects of Cannabis: Assessing Analgesic, Abuse-related and Pharmacokinetic Differences Between Men and Women
This study tests how cannabis can help relieve pain and whether it leads to different levels of abuse in men and women.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 21 Years to 55 Years |
| Sex | All |
| Sponsor | University of California, Los Angeles Academic / other |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT04385082 on ClinicalTrials.gov |
What this trial studies
This research aims to evaluate how cannabis affects pain relief and potential abuse differently in men and women. The study will involve administering both active cannabis and a placebo to participants while measuring the dose-dependent effects of THC. It will also explore the pharmacokinetics of THC to understand the underlying reasons for any observed sex-dependent differences. Participants will be closely monitored to assess their responses and any adverse effects.
Who should consider this trial
Good fit: Ideal candidates are males or non-pregnant females aged 21-55 who use cannabis regularly and are not seeking treatment for their cannabis use.
Not a fit: Patients with a history of severe psychiatric illness or those meeting criteria for substance use disorders other than cannabis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more tailored cannabis-based pain management strategies that consider sex differences.
How similar studies have performed: While there have been studies on cannabis effects, this specific focus on sex differences in analgesic and abuse-related effects is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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/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
Where this trial is running
Los Angeles, California
- University of California, Los Angeles — Los Angeles, California, United States (Recruiting)
Study contacts
- Principal investigator: Ziva Cooper, PhD — University of California, Los Angeles
- Study coordinator: Ziva Cooper, PhD
- Email: zcooper@mednet.ucla.edu
- Phone: 310-206-9942
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.