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 range40 Years – 70 Years
SexFEMALE
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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
✓. 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
✕. current parole or probation
✕. 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
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
✕. significant uncontrolled medical illness (such as uncontrolled diabetes or hypertension, clinically significant laboratory abnormalities, liver function tests (LFTs)\>3x upper limit of normal)