Acute Effects of Cannabis on Cognition and Mobility in Older HIV-infected and HIV-Un-infected Women (NCT03633721) | Clinical Trial Compass
CompletedPhase 2
Acute Effects of Cannabis on Cognition and Mobility in Older HIV-infected and HIV-Un-infected Women
United States25 participantsStarted 2020-10-23
Plain-language summary
The purpose of this study is to try to understand and explain why HIV-infected and uninfected women who use cannabis (marijuana) currently, or have used cannabis in the past, have higher risk of having experienced a fall in our earlier analyses in WIHS. This study will compare what happens when women are given cannabis compared with placebo, on measures of mobility, including walking speed under walking conditions that vary in terms of difficulty; for example normal walking and walking while reciting alternate letters of the alphabet, as well as measures of balance and cognition (for example attention, memory).
Who can participate
Age range
40 Years – 70 Years
Sex
FEMALE
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
. current cannabis use (within 6 months) based on self-report
. able to perform study procedures, including ability to ambulate independently
. adequate hearing and vision
. for HIV+ women use of stable HAART for at least 6 months.
Exclusion criteria
. pregnancy
. current illicit drug use other than cannabis
. request for substance use treatment
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 Acute Effects of Cannabis on Mobility Gait Speed (m/s)
Timeframe: Baseline, 15 minutes, and 60 minutes after taking cannabis or placebo during first visit. Duration between 1st and 2nd visits up to 7 months apart
2
Change in Acute Effects of Cannabis on Balance - Functional Reach (cm)
Timeframe: Baseline, 15 minutes, and 60 minutes after taking cannabis or placebo during first visit. Duration between 1st and 2nd visits up to 7 months apart
3
Change in Acute Effects of Cannabis on Cognition Using Sustained Attention Response Test (% Correct Suppressions)
Timeframe: Baseline, 15 minutes, and 60 minutes after taking cannabis or placebo during first visit. Duration between 1st and 2nd visits up to 7 months apart
. recent history of significant violent behavior (within 12 months)
. major current Axis I psychopathology (e.g.,bipolar disorder, suicide risk, schizophrenia)
. current use of psychiatric medication known to influence cognition
. significant uncontrolled medical illness (such as uncontrolled diabetes or hypertension, clinically significant laboratory abnormalities, liver function tests (LFTs)\>3x upper limit of normal)