Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT03633721 |
Other study ID # |
2018-9188 |
Secondary ID |
R21AG059505-01 |
Status |
Completed |
Phase |
Phase 2
|
First received |
|
Last updated |
|
Start date |
October 23, 2020 |
Est. completion date |
May 31, 2022 |
Study information
Verified date |
April 2022 |
Source |
Albert Einstein College of Medicine |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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).
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:
1. 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
2. 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.