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Stress-Reactivity and Cannabis Use in Cannabis-Using Older Adults (PUMA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05072795
Recruitment Status : Recruiting
First Posted : October 11, 2021
Last Update Posted : January 11, 2022
Sponsor:
Collaborators:
National Institute on Aging (NIA)
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Andreana Benitez, Medical University of South Carolina

Brief Summary:
The goal of the study is to evaluate how cannabis use affects memory and thinking skills and response to stress in older adults. The study will also relate cannabis use to Alzheimer's Disease (AD) biomarkers (measurable substances in blood that indicate condition), and test whether sex and hormones play a role in these effects. The study is recruiting adults between the ages of 50 and 80 who use cannabis products on a regular basis. Study participation will last about two weeks.

Condition or disease Intervention/treatment Phase
Cannabis Use Behavioral: Trier Social Stress Task (TSST) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: MUSC Specialized Center of Research Excellence (SCORE) on Sex Differences: Stress-Reactivity and Cannabis Use in Cannabis-Using Older Adults
Actual Study Start Date : November 19, 2021
Estimated Primary Completion Date : August 2023
Estimated Study Completion Date : September 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana

Arm Intervention/treatment
Experimental: Stress Induction Behavioral: Trier Social Stress Task (TSST)
The TSST is a standardized psychological stress challenge which provokes a stress response in a laboratory setting. During the task, saliva samples will be collected for hormone testing along with physiological and subjective measures.




Primary Outcome Measures :
  1. Global Cognitive Ability (GCA) [ Time Frame: Day 0 to Day 8 ]
    The primary outcome is the mean Global Cognitive Ability (GCA) z-score, which is a psychometrically robust, factor analytically-derived, demographically-normed index of global cognitive function. Lower z-scores represent a lower level of cognitive function. The investigator will test the hypothesis that women with CUD will have lower GCA scores than men.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 50-80.
  • Women must be >1 year post-menopausal.
  • English as a first/primary language.
  • Functional visual and auditory acuity (aided or unaided) to complete tests.
  • Capacity to independently provide informed consent and function at an intellectual level sufficient to allow completion of all instruments.
  • Currently meets DSM-5 criteria for CUD.
  • Consent to abstain from alcohol and cannabis use for >12 hours prior to Study Visit (Day 0), and TSST (Day 8).
  • Consent to abstain from all drugs other than cannabis or nicotine for the duration of the study.

Exclusion Criteria:

  • Meet DSM-5 criteria for moderate or severe alcohol or substance use disorder (other than nicotine or cannabis) within the last 12 months.
  • History of major neurocognitive disorder or developmental disorder per DSM-5.
  • A Telephone Interview for Cognitive Status (TICS) score of less than or equal to 22.
  • Significant or unstable medical condition/s that impact cognition as deemed by study investigators, such as active significant cardiac, cerebrovascular, neoplastic, infectious, or metabolic disease, or longstanding and intractable severe mental illness (e.g. schizophrenia spectrum disorder, bipolar disorder).
  • Daily use of medications that adversely impact cognition in aging (i.e. anticholinergics and sedatives).
  • Current suicidal or homicidal ideation/risk.
  • Unable to complete/comply with procedures or pose threat to research staff.

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): NCT05072795


Contacts
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Contact: Reyna Hickey 843-792-5573 hickeyre@musc.edu
Contact: Katrina Madden 843-792-9186 maddenka@musc.edu

Locations
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United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Reyna Hickey    843-792-5573    hickeyre@musc.edu   
Contact: Katrina Madden    843-792-9186    maddenka@musc.edu   
Principal Investigator: Andreana Benitez, PhD         
Sub-Investigator: Aimee McRae-Clark, PharmD         
Sponsors and Collaborators
Medical University of South Carolina
National Institute on Aging (NIA)
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Andreana Benitez, PhD Medical University of South Carolina
Principal Investigator: Aimee Aimee McRae-Clark, PharmD Medical University of South Carolina
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Responsible Party: Andreana Benitez, Assistant Professor, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT05072795    
Other Study ID Numbers: 00111432
3U54DA016511-19S1 ( U.S. NIH Grant/Contract )
First Posted: October 11, 2021    Key Record Dates
Last Update Posted: January 11, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Marijuana Abuse
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders