PUMA: Stress-Reactivity and Cannabis Use in Cannabis-Using Older Adults

Sponsor
Medical University of South Carolina (Other)
Overall Status
Recruiting
CT.gov ID
NCT05072795
Collaborator
National Institute on Aging (NIA) (NIH), National Institute on Drug Abuse (NIDA) (NIH)
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Study Details

Study Description

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
  • Behavioral: Trier Social Stress Task (TSST)
N/A

Study Design

Study Type:
Interventional
Anticipated 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 :
Nov 19, 2021
Anticipated Primary Completion Date :
Aug 1, 2023
Anticipated Study Completion Date :
Sep 1, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Global Cognitive Ability (GCA) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Medical University of South Carolina Charleston South Carolina United States 29425

Sponsors and Collaborators

  • Medical University of South Carolina
  • National Institute on Aging (NIA)
  • National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: Andreana Benitez, PhD, Medical University of South Carolina
  • Principal Investigator: Aimee Aimee McRae-Clark, PharmD, Medical University of South Carolina

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Andreana Benitez, Assistant Professor, Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT05072795
Other Study ID Numbers:
  • 00111432
  • 3U54DA016511-19S1
First Posted:
Oct 11, 2021
Last Update Posted:
Jan 11, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 11, 2022