HIVPhase 2NCT03633721

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

A Phase 2 study testing Cannabis in people with HIV and AIDS, run by Albert Einstein College of Medicine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 40 to 70 years, women onlyHealthy volunteers can take part
Conditions the study is for: HIV, AIDS, Aging
What is being tested?: Cannabis
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 25 participants
Where: 1 siteUnited States
Study dates: 23 Oct 2020to 31 May 2022
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 to 70 years
Women only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Who cannot join

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)

Show all 14Show fewer

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).

Trial locations and contacts

1 site in 1 country.

United States1 site

Montefiore Medical Center
The Bronx, New York, 10461

Other trials in United States

About this study

Official title: Acute Effects of Cannabis on Cognition and Mobility in Older HIV-infected and Uninfected Women

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).

Read the detailed description

Cannabis is the most prevalent drug used by adults aged 50 and older in the U.S., after alcohol and tobacco. Recent trends show dramatic increases in cannabis use among older U.S. adults, and rising cannabis tetrahydrocannabinol (THC) content. Cannabis intoxication acutely alters short-term memory, attention span, verbal fluency, reaction time, and psychomotor control. Heavy long term cannabis use has been associated with lasting impairments in verbal learning, memory, and attention that correlate with duration of use; however, other studies have found that cognitive deficits from cannabis are reversible and related to recent exposure. But studies on cannabis exposure and cognition are age limited by including only adolescents through middle-aged adults; effects of acute and long-term cannabis use on cognition among older adults are virtually unknown. Given the rising potency and increasing frequency of cannabis use among older adults, studies systematically examining the risks and benefits of cannabis use in older adults are urgently needed.

Cannabis use is particularly common in people living with HIV (PLWH), with 12- 56% prevalence rates compared to 9.5% in the general U.S. population. HIV has detrimental effects on both mobility and cognition, and similar to normal aging, mobility in patients with HIV may be influenced by cognitive function. Mild-to-moderate neurocognitive impairments (NCI), notably in attention and executive functions, remain highly prevalent and persist despite suppressive antiretroviral therapy, affecting almost half of PLWH. Little is known about the combined effects of cannabis use and HIV infection on cognition and mobility, particularly among older individuals. As the population of older PLWH continues to grow, co-occurring aging and HIV related declines in cognition and mobility will coincide; the effects of continued cannabis use In the Women's Interagency HIV Study (WIHS), it was found that current cannabis use was associated with over double the odds of single fall, and over 2.5 times the odds of multiple falls in 6 months; past cannabis use was associated with over 1.5 greater odds of single fall and multiple falls. Preliminary data shows that 40% of WIHS women (mean age 48) reported at least one fall over 2 years; current cannabis users had 1.7 times greater fall risk among HIV+ but not HIV-women. The hypothesis is that falls are related to acute effects of cannabis on attention and mobility, and that given subtle, pre-existing deficits associated with HIV infection, these acute cannabis effects may be more pronounced in HIV+ women, placing them at increased risks of falls. Whether this observed fall risk associated with cannabis use represents acute effects, or persistent effects of past cannabis use on cognition, balance, or mobility, or whether adverse effects of cannabis differ by HIV status merits further study in this aging population.

The "Walking While Talking" (WWT) test requires individuals to walk while performing a secondary attention-demanding task (dual task), has been used to assess the interactions between cognition and gait, and provides a framework for evaluating the effect of divided attention, a facet of executive functions, on mobility. Increased dual task costs measured using WWT may help unmask subtle and latent cognitive abnormalities before they become clinically apparent by increasing the complexity of the walking condition, and predict falls, frailty, disability, and mortality among older community-residing adults. Because both cannabis use and HIV have been implicated in impairments in attention and executive functions, the WWT may be a quick and simple mobility stress test to identify subtle cognitive and motor effects of acute cannabis administration as a function of HIV status.

The objective is to explore the mechanisms that underlie the increased fall risk associated with cannabis use. The effects of controlled administration of active (7.0% THC) and inactive (0.0%) cannabis in aging HIV+ women on stable HAART and HIV- controls enrolled on the WIHS will be compared. Endpoints will be balance, mobility, and cognition, including a cognitive-motor divided attention task (WWT). Specific aims and hypotheses are:

To determine the acute effects of cannabis on balance and mobility among older HIV+ and HIV- women. These test will be performed within subject comparisons of performance on balance and mobility tests at two supervised visits, with administration of placebo vs. active cannabis in counter-balanced order. The hypothesis is that HIV+ women will have greater impairment on balance and mobility, especially on complex walking conditions that demand attention, with administration of active cannabis than HIV- women
To determine the acute effects of cannabis on cognition among older HIV+ and HIV- women.HIV+ women will have greater impairment on cognitive testing, especially in attention, with administration of active cannabis than HIV- women.

Conditions: HIV, AIDS, Aging
Being tested: Cannabis, Placebo
Keywords: mobility, cognition, WIHS
Medical subject headings: Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CannabisDrug
Also called Cannabis administered to HIV+ and HIV- women
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.
PlaceboOther
Also called Placebo administered to HIV+ and HIV- women
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.

Study groups in NCT03633721
Study group	Role	What they receive
HIV positive; cannabis	Active comparator	HIV positive women will be given cannabis and tested Receives: Drug: Cannabis; Other: Placebo
HIV positive; placebo	Placebo comparator	HIV positive women will be given placebo and tested Receives: Drug: Cannabis; Other: Placebo
HIV negative; cannabis	Active comparator	HIV negative women will be given cannabis and tested Receives: Drug: Cannabis; Other: Placebo
HIV negative; placebo	Placebo comparator	HIV negative women will be given placebo and tested Receives: Drug: Cannabis; Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 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).
Measured: 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.
Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Oct 202031 May 2022

First posted16 Aug 2018
Study start23 Oct 2020
Primary completion31 May 2022
Study completion31 May 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HIVStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Model description: Participants will receive either cannabis or placebo on 1st visit and the opposite on the 2nd visit.
Masking: Double blind
Who is masked: Participant, Care provider
Enrolment: 25 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03633721
Sponsor's protocol ID: 2018-9188
Other IDs: R21AG059505-01
Status last verified: Sep 2025
First submitted: 10 Aug 2018
Last updated: 15 Oct 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Sharing of data generated by this study is an essential part of our proposed activities and will be carried out in terms of presentations at national and international scientific meetings as well as with publications in peer-reviewed journals. We would wish to make our results available to the community of scientists interested in understanding the consequences of substance use in older persons living with HIV, to foster future collaborative efforts and to avoid unintentional duplication of research.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All HIV trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Acute Effects of Cannabis on Cognition and Mobility in Older HIV-infected and Uninfected Women
ClinicalTrials.gov ID: NCT03633721
Acronym / sponsor ID: 2018-9188
Conditions: HIV, AIDS, Aging
Keywords: mobility, cognition, WIHS
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 25 participants (actual)
Lead sponsor: Albert Einstein College of MedicineUniversity, hospital or other
Collaborators: National Institute on Aging (NIA)
Study start: 23 Oct 2020 (actual)
Primary completion: 31 May 2022 (actual)
Study completion: 31 May 2022 (actual)
First posted: 16 Aug 2018 (actual)
Results: Posted 15 Oct 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

To determine the acute effects of cannabis on balance and mobility among older HIV+ and HIV- women. These test will be performed within subject comparisons of performance on balance and mobility tests at two supervised visits, with administration of placebo vs. active cannabis in counter-balanced order. The hypothesis is that HIV+ women will have greater impairment on balance and mobility, especially on complex walking conditions that demand attention, with administration of active cannabis than HIV- women
To determine the acute effects of cannabis on cognition among older HIV+ and HIV- women.HIV+ women will have greater impairment on cognitive testing, especially in attention, with administration of active cannabis than HIV- women.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, care provider)
Number of arms: 4
Model description: Participants will receive either cannabis or placebo on 1st visit and the opposite on the 2nd visit.

Arm	Type	Receives
HIV positive; cannabis	Active comparator	Drug: Cannabis, Other: PlaceboHIV positive women will be given cannabis and tested
HIV positive; placebo	Placebo comparator	Drug: Cannabis, Other: PlaceboHIV positive women will be given placebo and tested
HIV negative; cannabis	Active comparator	Drug: Cannabis, Other: PlaceboHIV negative women will be given cannabis and tested
HIV negative; placebo	Placebo comparator	Drug: Cannabis, Other: PlaceboHIV negative women will be given placebo and tested

Who may qualify

Ages: 40 to 70 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (14 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CannabisAlso: Cannabis administered to HIV+ and HIV- women7% 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.	Drug	HIV negative; cannabis, HIV negative; placebo, HIV positive; cannabis, HIV positive; placebo
PlaceboAlso: Placebo administered to HIV+ and HIV- women0% 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.	Other	HIV negative; cannabis, HIV negative; placebo, HIV positive; cannabis, HIV positive; placebo

Primary outcome

Change in Acute Effects of Cannabis on Mobility Gait Speed (m/s)
Time frame: 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
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).
Change in Acute Effects of Cannabis on Balance - Functional Reach (cm)
Time frame: 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 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).
Change in Acute Effects of Cannabis on Cognition Using Sustained Attention Response Test (% Correct Suppressions)
Time frame: 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
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.

Results and safety

Results posted to the registry on 15 Oct 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
HIV Sero Positive: Cannabis 7% delta9-THC Cigarettes First, Then Placebo 0% THC Cigarettes	10	10
HIV Sero Positive: Placebo 0% THC Cigarettes First, Then Cannabis 7% delta9-THC Cigarettes	4	4
HIV Sero Negative: Cannabis 7% delta9-THC Cigarettes First, Then Placebo 0% THC Cigarettes	5	5
HIV Sero Negative: Placebo 0% THC Cigarettes First, Then Cannabis 7% delta9-THC Cigarettes	6	6

Primary outcome: Change in Acute Effects of Cannabis on Mobility Gait Speed (m/s)

Time frame: 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. Mean (Standard Error). Unit: m/s

Measure	HIV Sero Positive: Cannabis 7% delta9-THC Cigarettes First, Then Placebo 0% THC Cigarettes n = 8	HIV Sero Positive: Placebo 0% THC Cigarettes First, Then Cannabis 7% delta9-THC Cigarettes n = 3	HIV Sero Negative: Cannabis 7% delta9-THC Cigarettes First, Then Placebo 0% THC Cigarettes n = 5	HIV Sero Negative: Placebo 0% THC Cigarettes First, Then Cannabis 7% delta9-THC Cigarettes n = 5
Baseline using Placebo	2.89 (0.16)	3.11 (0.54)	2.87 (0.26)	2.99 (0.32)
Mean of 15 minute and 60 minute timepoint using Placebo	2.86 (0.15)	3.16 (0.53)	3.04 (0.23)	2.92 (0.20)
Change from Baseline using Placebo	-0.03 (0.09)	0.05 (0.19)	0.16 (0.05)	-0.07 (0.14)
Baseline using Cannabis	2.80 (0.17)	3.34 (0.70)	2.59 (0.33)	3.05 (0.31)
Mean of 15 minute and 60 minute timepoint using Cannabis	2.82 (0.12)	3.03 (0.59)	2.80 (0.34)	3.14 (0.18)
Change from Baseline using Cannabis	0.02 (0.14)	-0.31 (0.25)	0.21 (0.05)	0.08 (0.20)
Change from Baseline to Mean of 15 & 60 minutes for Cannabis minus that for Placebo	0.05 (0.11)	-0.35 (0.45)	0.04 (0.05)	0.15 (0.14)

HIV Sero Positive: Cannabis 7% delta9-THC Cigarettes First, Then Placebo 0% THC Cigarettes vs HIV Sero Positive: Placebo 0% THC Cigarettes First, Then Cannabis 7% delta9-THC Cigarettes vs HIV Sero Negative: Cannabis 7% delta9-THC Cigarettes First, Then Placebo 0% THC Cigarettes vs HIV Sero Negative: Placebo 0% THC Cigarettes First, Then Cannabis 7% delta9-THC Cigarettes: p = 0.17, ANOVA

Primary outcome: Change in Acute Effects of Cannabis on Balance - Functional Reach (cm)

Time frame: 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. Mean (Standard Error). Unit: cm

Measure	HIV Sero Positive: Cannabis 7% delta9-THC Cigarettes First, Then Placebo 0% THC Cigarettes n = 8	HIV Sero Positive: Placebo 0% THC Cigarettes First, Then Cannabis 7% delta9-THC Cigarettes n = 3	HIV Sero Negative: Cannabis 7% delta9-THC Cigarettes First, Then Placebo 0% THC Cigarettes n = 5	HIV Sero Negative: Placebo 0% THC Cigarettes First, Then Cannabis 7% delta9-THC Cigarettes n = 5
Baseline using Placebo	28.22 (2.58)	18.77 (3.36)	36.75 (5.15)	29.72 (3.74)
Mean of 15 minute and 60 minute timepoint using Placebo	26.92 (3.32)	26.40 (5.72)	32.13 (5.93)	28.21 (3.95)
Change from Baseline using Placebo	-1.30 (1.66)	3.64 (2.84)	-4.61 (1.63)	-1.51 (0.79)
Baseline using Cannabis	28.71 (3.71)	22.39 (4.59)	31.34 (3.82)	34.26 (6.06)
Mean of 15 minute and 60 minute timepoint using Cannabis	29.65 (4.00)	18.04 (3.09)	33.87 (4.51)	30.93 (2.37)
Change from Baseline using Cannabis	0.94 (3.71)	-4.35 (2.36)	2.52 (1.60)	-3.33 (3.98)
Change from Baseline to Mean of 15 & 60 minutes for Cannabis minus that for Placebo	2.24 (3.41)	-7.99 (3.79)	7.14 (2.01)	-1.82 (4.64)

HIV Sero Positive: Cannabis 7% delta9-THC Cigarettes First, Then Placebo 0% THC Cigarettes vs HIV Sero Positive: Placebo 0% THC Cigarettes First, Then Cannabis 7% delta9-THC Cigarettes vs HIV Sero Negative: Cannabis 7% delta9-THC Cigarettes First, Then Placebo 0% THC Cigarettes vs HIV Sero Negative: Placebo 0% THC Cigarettes First, Then Cannabis 7% delta9-THC Cigarettes: p = 0.18, ANOVA

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

Time frame: 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. Mean (Standard Error). Unit: Percentage of correct suppressions

Measure	HIV Sero Positive: Cannabis 7% delta9-THC Cigarettes First, Then Placebo 0% THC Cigarettes n = 8	HIV Sero Positive: Placebo 0% THC Cigarettes First, Then Cannabis 7% delta9-THC Cigarettes n = 3	HIV Sero Negative: Cannabis 7% delta9-THC Cigarettes First, Then Placebo 0% THC Cigarettes n = 5	HIV Sero Negative: Placebo 0% THC Cigarettes First, Then Cannabis 7% delta9-THC Cigarettes n = 5
Baseline using Placebo	84.00 (1.51)	64.00 (16.17)	87.40 (3.71)	79.20 (9.75)
Mean of 15 minute and 60 minute timepoint using Placebo	82.25 (2.25)	78.67 (6.77)	74.00 (10.62)	78.40 (10.05)
Change from Baseline using Placebo	-1.75 (2.25)	14.67 (10.09)	-12.40 (8.01)	-0.80 (7.58)
Baseline using Cannabis	80.50 (5.58)	85.33 (2.67)	90.40 (4.49)	80.00 (12.77)
Mean of 15 minute and 60 minute timepoint using Cannabis	85.50 (2.80)	88.67 (3.53)	80.00 (7.80)	78.00 (13.90)
Change from Baseline using Cannabis	5.00 (3.96)	3.33 (1.33)	-10.00 (8.01)	-2.00 (1.67)
Change from Baseline to Mean of 15 & 60 minutes for Cannabis minus that for Placebo	6.75 (5.14)	-11.33 (11.10)	2.00 (5.10)	-1.20 (9.02)

HIV Sero Positive: Cannabis 7% delta9-THC Cigarettes First, Then Placebo 0% THC Cigarettes vs HIV Sero Positive: Placebo 0% THC Cigarettes First, Then Cannabis 7% delta9-THC Cigarettes vs HIV Sero Negative: Cannabis 7% delta9-THC Cigarettes First, Then Placebo 0% THC Cigarettes vs HIV Sero Negative: Placebo 0% THC Cigarettes First, Then Cannabis 7% delta9-THC Cigarettes: p = 0.72, ANOVA

Adverse events

Time frame: Participants were monitored during the two study visits, up to approximately 7 months total. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
HIV Sero Positive: Cannabis 7% delta9-THC Cigarettes	0 of 13 (0%)	0 of 13 (0%)	0 of 13
HIV Sero Positive: Placebo 0% THC Cigarettes	0 of 12 (0%)	0 of 12 (0%)	0 of 12
HIV Sero Negative: Cannabis 7% delta9-THC Cigarettes	0 of 10 (0%)	0 of 10 (0%)	0 of 10
HIV Sero Negative: Placebo 0% THC Cigarettes	0 of 11 (0%)	0 of 11 (0%)	0 of 11

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. Sharing of data generated by this study is an essential part of our proposed activities and will be carried out in terms of presentations at national and international scientific meetings as well as with publications in peer-reviewed journals. We would wish to make our results available to the community of scientists interested in understanding the consequences of substance use in older persons living with HIV, to foster future collaborative efforts and to avoid unintentional duplication of research.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Anjali Sharma, MD, MS principal investigator

Albert Einstein College of Medicine

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cannabis in people with HIV and AIDS, run by Albert Einstein College of Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Acute Effects of Cannabis on Mobility Gait Speed (m/s) (time frame: 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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03633721.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2025.