Cannabis Effects as a Function of Sex (NCT04385082) | Clinical Trial Compass
RecruitingPhase 1
Cannabis Effects as a Function of Sex
United States160 participantsStarted 2021-07-08
Plain-language summary
The purpose of this research is to assess the impact of cannabis on the analgesic and abuse-related effects between men and women
Who can participate
Age range
21 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.