Phase 2
N=25
Acute Effects of Cannabis on Cognition and Mobility in Older HIV-infected and HIV-Un-infected Women
HIV · AIDS · Aging
Bottom Line
View on ClinicalTrials.gov: NCT03633721 ↗Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Oct 2025
Primary outcome: Primary: Change in Acute Effects of Cannabis on Mobility Gait Speed (m/s) — 2.89; 3.11; 2.87; 2.99 m/s — p=0.17
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Cannabis (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- Female
- Sponsor
- Albert Einstein College of Medicine
- Primary completion
- May 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Acute Effects of Cannabis on Mobility Gait Speed (m/s) |
2.89; 3.11; 2.87; 2.99; 2.86; 3.16 | 0.17 |
| PRIMARY Change in Acute Effects of Cannabis on Balance - Functional Reach (cm) |
28.22; 18.77; 36.75; 29.72; 26.92; 26.40 | 0.18 |
| PRIMARY Change in Acute Effects of Cannabis on Cognition Using Sustained Attention Response Test (% Correct Suppressions) |
84.00; 64.00; 87.40; 79.20; 82.25; 78.67 | 0.72 |
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).
Eligibility Criteria
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
- significant uncontrolled medical illness (such as uncontrolled diabetes or hypertension, clinically significant laboratory abnormalities, liver function tests (LFTs)>3x upper limit of normal)
- history of active heart disease within 12 months
- history of dementia
- severe hand tremor
- history of Central Nervous System (CNS) diseases or injury
- poor English fluency.
All participants will be consented and compensated for their effort as approved by the Institutional Review Boards (IRBs) of each participating institution (see human subjects).
Data sourced from ClinicalTrials.gov (NCT03633721). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.