Acute Effects of Cannabis on Cognition and Mobility in Older HIV-infected and HIV-Un-infected Women

NCT03633721 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: 2018-9188R21AG059505-01
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

HIV; AIDS; Aging

Keywords

mobility; cognition; WIHS

Outcome Measures

Primary Outcomes (3)

• Change in Acute Effects of Cannabis on Mobility Gait Speed (m/s)

  Mobility Gait Speed will be tested using the timed gait speed test. Gait speed is measured and reported under normal walking and attention demanding measures. Change in mobility as a function of timed gait speed from before cannabis, or placebo use, to after cannabis, or placebo, use at the 15 minute and 60 minute timepoints will be assessed. The baseline measurement, the mean of the two timepoint measurements, changes from the baselines, and change from the baseline to mean of 15 \& 60 minutes for Cannabis minus that for Placebo, will be reported in meters/second (m/s).

  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

• Change in Acute Effects of Cannabis on Balance - Functional Reach (cm)

  Change in balance from baseline will be tested using the Functional Reach test. Functional reach measures the distance the subject can reach in front of them from a standing position without losing balance. Change in balance from before cannabis, or placebo, use to after cannabis, or placebo, use at the 15 minute and 60 minute timepoints will be assessed. The baseline measurement, the mean of the two timepoint measurements, changes from the baselines, and change from the baseline to mean of 15 \& 60 minutes for Cannabis minus that for Placebo, will be reported in centimeters (cm).

  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

• Change in Acute Effects of Cannabis on Cognition Using Sustained Attention Response Test (% Correct Suppressions)

  Cognition will be tested using the number of correct suppressions on the Sustained Attention to Response Task (SART). Participants were asked to respond to a series of digits on a computer screen by pressing a key as quickly as possible for every digit except "3". The percentage of correct suppressions is quantified. Change in the percentage of mean correct suppressions before cannabis (or placebo) use to after cannabis (or placebo) at the 15 minute and 60 minute timepoints will be assessed. The baseline measurement, the mean percentage of the two timepoint measurements, the mean percentage changes from baseline values, and change from the baseline to mean of 15 \& 60 minutes for Cannabis minus that for Placebo, will be reported.

  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

Study Arms (4)

HIV positive; cannabis

ACTIVE COMPARATOR

HIV positive women will be given cannabis and tested

Drug: Cannabis; Other: Placebo

HIV positive; placebo

PLACEBO COMPARATOR

HIV positive women will be given placebo and tested

Drug: Cannabis; Other: Placebo

HIV negative; cannabis

ACTIVE COMPARATOR

HIV negative women will be given cannabis and tested

Drug: Cannabis; Other: Placebo

HIV negative; placebo

PLACEBO COMPARATOR

HIV negative women will be given placebo and tested

Drug: Cannabis; Other: Placebo

Interventions

Cannabis DRUG

7% delta9-THC cigarettes will be smoked by 'light the cigarette' (30 sec), 'get ready' (5 sec), 'inhale' (5 sec), 'hold smoke in lungs' (10 sec) and 'exhale.' Participants will smoke 3 puffs in this manner, with a 40-sec interval between each puff.

Also known as: Cannabis administered to HIV+ and HIV- women

HIV negative; cannabis; HIV negative; placebo; HIV positive; cannabis; HIV positive; placebo

Placebo OTHER

0% THC cigarettes will be administered to HIV negative women. Participants will be instructed to 'light the cigarette' (30 sec), 'get ready' (5 sec), 'inhale' (5 sec), 'hold smoke in lungs' (10 sec) and 'exhale.' Participants will smoke 3 puffs in this manner, with a 40-sec interval between each puff.

Also known as: Placebo administered to HIV+ and HIV- women

HIV negative; cannabis; HIV negative; placebo; HIV positive; cannabis; HIV positive; placebo

Eligibility Criteria

• Age: 40 Years - 70 Years
• Gender Eligibility Details: Female only cohort
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Albert Einstein College of Medicine: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10461, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

nabiximols

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Results Point of Contact

• Title: Dr. Anjali Sharma
• Organization: Albert Einstein College of Medicine

anjali.sharma@einsteinmed.edu

7185152593

Study Officials

• Anjali Sharma, MD, MS

  Albert Einstein College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Neither participant nor care provider will be informed when cannabis/placebo are administered.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will receive either cannabis or placebo on 1st visit and the opposite on the 2nd visit.

Study Record Dates

• First Submitted: August 10, 2018
• First Posted: August 16, 2018
• Study Start: October 23, 2020
• Primary Completion: May 31, 2022
• Study Completion: May 31, 2022
• Last Updated: October 15, 2025
• Results First Posted: October 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data sets can be shared once analysis has been completed.
• Access Criteria: The Data Analysis and Coordination Center (DACC) shares data to all investigators (internal and external) with Executive Committee (EC)-approved concept sheets. The concept sheet form requests information on the project background, specific aims and hypotheses, study design, laboratory and quality assurance methods, and plans for data analysis. All requests should be submitted online.

Locations

US (1)