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

MUSC Specialized Center of Research Excellence (SCORE) on Sex Differences: Stress-Reactivity and Cannabis Use in Cannabis-Using Older Adults

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.

Study Overview

• Status: Completed
• Conditions: Cannabis Use
• Intervention / Treatment: Behavioral: Trier Social Stress Task (TSST)

• Study Type: Interventional
• Enrollment (Actual): 47
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 or uses cannabis at least 4 days per week
• 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.
• Standard MRI contraindications (e.g., implants, claustrophobia).
• Women who are pregnant, nursing, or of childbearing potential and not practicing and effective means of birth control.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Stress Induction; Participants completed the Trier Social Stress Test (TSST)	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.
No Intervention: No intervention; Participants did not complete the Trier Social Stress Test (TSST).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Global Cognitive Ability (GCA)	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. A Z-score of 0 represents the population mean with positive scores indicating a higher level of cognitive function and negative scores indicating a lower level of cognitive function than the mean. The investigator will test the hypothesis that women with CUD will have lower GCA scores than men.	Day 0

Collaborators and Investigators

• Sponsor: Medical University of South Carolina
• Collaborators: National Institute on Drug Abuse (NIDA); National Institute on Aging (NIA)
• Investigators: Principal Investigator: Andreana Benitez, PhD, Medical University of South Carolina; Principal Investigator: Aimee Aimee McRae-Clark, PharmD, Medical University of South Carolina

Study record dates

Study Major Dates

• Study Start (Actual): November 19, 2021
• Primary Completion (Actual): June 7, 2023
• Study Completion (Actual): June 7, 2023

Study Registration Dates

• First Submitted: September 24, 2021
• First Submitted That Met QC Criteria: October 5, 2021
• First Posted (Actual): October 11, 2021

Study Record Updates

• Last Update Posted (Actual): August 1, 2024
• Last Update Submitted That Met QC Criteria: July 9, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Marijuana Abuse
• Other Study ID Numbers: 00111432; 3U54DA016511-19S1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No