Effect of Medical Marijuana on Neurocognition and Escalation of Use (NCT03224468) | Clinical Trial Compass
CompletedNot Applicable
Effect of Medical Marijuana on Neurocognition and Escalation of Use
United States269 participantsStarted 2017-07-01
Plain-language summary
This study will use a randomized controlled design to test whether patients who use medical marijuana, compared to a waitlist control group, experience a change in health outcomes (relief of symptoms, or adverse health outcomes such as new-onset symptoms of cannabis use disorders, neurocognitive impairments) or brain-based changes.
Who can participate
Age range
18 Years – 65 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
. Men and women aged 18-65 years, inclusive;
. Competent and willing to provide written informed consent;
. Desire to use medical marijuana for self-reported pain, sleep, or affective (mood and/or anxiety including PTSD) symptoms.
. Not in possession of a medical marijuana card, but expressing intent to get one.
. Able to communicate in English language.
Exclusion criteria
. Current daily marijuana use (prior to enrollment)
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
Mean Difference in Number of Cannabis Use Disorder Symptoms Averaged Over 2, 4, and 12 Weeks
Timeframe: 2 weeks, 4 weeks, and 12 weeks
2
Mean Difference in Depression Subscale Scores From the HADS Averaged Over 2, 4, and 12 Weeks
Timeframe: 2 weeks, 4 weeks, and 12 weeks
3
Mean Difference in Anxiety Subscale Scores From the HADS Averaged Over 2, 4, and 12 Weeks
Timeframe: 2 Weeks, 4 Weeks, and 12 Weeks
4
Mean Difference in Pain Severity Scores on the BPI Average Over 2, 4, and 12 Weeks
Timeframe: 2 weeks, 4 weeks, and 12 weeks
5
Mean Difference in Sleep Scores on the AIS Averaged Over 2, 4, and 12 Weeks
. Current substance use disorders (e.g. cocaine, opiate, stimulant). Light to moderate alcohol use is permitted (defined as 16 or less on the AUDIT), and nicotine dependence is permitted because of the high co-use of nicotine and marijuana. Participants cannot meet current SCID criteria for a use disorder on any illicit substance other than nicotine.
. Pregnant (verified by a urine test).
. In the opinion of the investigator, not able to safely participate in this study because of any medical or psychological issues (e.g. psychosis) that might compromise their safety.