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 range19 Years – 35 Years
SexALL
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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
✕. Are left-handed or ambidextrous
✕. Females: are pregnant, nursing, or not on safe pregnancy protection
✕
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
✕. 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: