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

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ClinicalTrials.gov Identifier: NCT03633721
Recruitment Status : Not yet recruiting
First Posted : August 16, 2018
Last Update Posted : April 30, 2019
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Anjali Sharma, Albert Einstein College of Medicine

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).

Condition or disease Intervention/treatment Phase
HIV AIDS Aging Drug: Cannabis Other: Placebo Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Participants will receive either cannabis or placebo on 1st visit and the opposite on the 2nd visit.
Masking: Double (Participant, Care Provider)
Masking Description: Neither participant nor care provider will be informed when cannabis/placebo are administered.
Primary Purpose: Other
Official Title: Acute Effects of Cannabis on Cognition and Mobility in Older HIV-infected and Uninfected Women
Estimated Study Start Date : July 16, 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS Marijuana

Arm Intervention/treatment
Active Comparator: HIV positive; cannabis
HIV positive women will be given cannabis and tested
Drug: Cannabis
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.
Other Name: Cannabis administered to HIV+ and HIV- women

Other: Placebo
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.
Other Name: Placebo administered to HIV+ and HIV- women

Active Comparator: HIV positive; placebo
HIV positive women will be given placebo and tested
Drug: Cannabis
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.
Other Name: Cannabis administered to HIV+ and HIV- women

Other: Placebo
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.
Other Name: Placebo administered to HIV+ and HIV- women

Active Comparator: HIV negative; cannabis
HIV negative women will be given cannabis and tested
Drug: Cannabis
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.
Other Name: Cannabis administered to HIV+ and HIV- women

Other: Placebo
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.
Other Name: Placebo administered to HIV+ and HIV- women

Active Comparator: HIV negative; placebo
HIV negative women will be given placebo and tested
Drug: Cannabis
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.
Other Name: Cannabis administered to HIV+ and HIV- women

Other: Placebo
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.
Other Name: Placebo administered to HIV+ and HIV- women




Primary Outcome Measures :
  1. Acute effects of cannabis on mobility [ Time Frame: Change in mobility as a function of timed gait from before cannabis to after cannabis which is the average of the 15 minute and 60 minute result. ]
    Mobility will be tested using the timed gait test. Gait speed is measured under normal walking and attention demanding measures.

  2. Acute effects of cannabis on balance [ Time Frame: The change in functional reach (in centimeters) will be measured from time 1 (30 minutes prior to cannabis) to the average of times 2 and 3 (15 min and 60 after cannabis) ]
    Balance will be tested using functional reach test. Functional reach measures the distance the subject can reach in front of her from a standing position without losing balance.

  3. Acute effects of cannabis on cognition [ Time Frame: The change on the Sustained Attention to Response Task (number of correct suppressions) will be measured from time 1 (30 minutes prior to cannabis) to the average of times 2 and 3 (15 min and 60 after cannabis) ]
    Cognition will be tested using the number of correct suppressions on the sustained Attention to Response Task (SART). The hypothesis is that following active cannabis administration, HIV+ women will perform worse than HIV- women on cognitive testing of attention. The groups will not differ following inactive cannabis administration.



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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female only cohort
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. current cannabis use (within 6 months) based on self-report
  2. able to perform study procedures, including ability to ambulate independently
  3. adequate hearing and vision
  4. for HIV+ women use of stable HAART for at least 6 months.

Exclusion Criteria:

  1. pregnancy
  2. current illicit drug use other than cannabis
  3. request for substance use treatment
  4. current parole or probation
  5. recent history of significant violent behavior (within 12 months)
  6. major current Axis I psychopathology (e.g.,bipolar disorder, suicide risk, schizophrenia)
  7. current use of psychiatric medication known to influence cognition
  8. significant uncontrolled medical illness (such as uncontrolled diabetes or hypertension, clinically significant laboratory abnormalities, liver function tests (LFTs)>3x upper limit of normal)
  9. history of active heart disease within 12 months
  10. history of dementia
  11. severe hand tremor
  12. history of Central Nervous System (CNS) diseases or injury
  13. 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).


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03633721


Contacts
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Contact: Anjali Sharma, MD, MS 718-430-2067 anjali.sharma@einstein.yu.edu
Contact: Kemi Sosanya, NP 718 654-7099 ksosanya@montefiore.org

Sponsors and Collaborators
Albert Einstein College of Medicine
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Anjali Sharma, MD, MS Albert Einstein Collge of Medicine

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Responsible Party: Anjali Sharma, Associate Professor, General Internal Medicine, Albert Einstein College of Medicine
ClinicalTrials.gov Identifier: NCT03633721     History of Changes
Other Study ID Numbers: 2018-9188
R21AG059505-01 ( U.S. NIH Grant/Contract )
First Posted: August 16, 2018    Key Record Dates
Last Update Posted: April 30, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (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.
URL: https://statepi.jhsph.edu/wihs/wordpress/wihs-public-data-set/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Anjali Sharma, Albert Einstein College of Medicine:
mobility
cognition
WIHS