Cannabis and Polysubstance Use: Response Inhibition and Stress Exposure (NCT05261321) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Cannabis and Polysubstance Use: Response Inhibition and Stress Exposure
Canada20 participantsStarted 2022-10-15
Plain-language summary
The purpose of this Phase I non-therapeutic trial is to examine the neurological effects of cannabis on stress reactivity and inhibition in healthy cannabis users. We expect differences between high ratio CBD:THC cannabis oil, low ratio CBD:THC cannabis oil, and/or placebo on outcome measures.
Who can participate
Age range
19 Years – 35 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
. Are 19-35 years old at the start of the study
. Have used oral cannabis, including at least 5mg of THC, at least once in their life
. Have used cannabis at least once in the past year
. Used cannabis less than 3 times per week on average, in the past 3 months
. Are using an effective and/or highly effective method of contraception and will continue to do so for the duration of participation in the study. Health Canada's definition of effective methods of contraception include barrier methods of contraception (e.g. male condom, female condom, cervical cap, diaphragm, contraceptive sponge). Health Canada's definition of highly effective methods of contraception includes hormonal contraceptives (e.g. combined oral contraceptives, patch, vaginal ring, injectables, and implants); intrauterine device (IUD) or intrauterine system (IUS); vasectomy and tubal ligation.
. Females: are not undergoing alternative fertility methods, such as IVF, or otherwise trying to start a family for the duration of participation
. Males: will not be donating sperm at some point during the duration of participation
. Are able to provide informed consent
Exclusion criteria
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.
What they're measuring
1
Change in stress response across conditions
Timeframe: 5 weeks
2
Change in incidence of adverse events of cannabinoids across conditions
Timeframe: 5 weeks
3
Procedure feasibility
Timeframe: Through study completion; average of 1 year
4
Protocol feasibility
Timeframe: Through study completion; average of 1 year
. Females: are pregnant, nursing, or not on safe pregnancy protection
. Are trying to conceive
. Have a known or suspected allergy to cannabinoids and/or palm/coconut oil
. Are hypersensitive to CBD and/or THC and/or have ever had an adverse reaction (an unwanted and unexpected reaction), to less than 40mg of CBD and/or 10mg THC
. Have had an adverse reaction (unwanted, unexpected reaction or symptoms) to cannabis within last 6 months
. Have a major physical problem/health concern, including: