Skip to main content
OpenTrials
Completed

NCT Number: NCT05072795

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Trier Social Stress Task (TSST)

Behavioral

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 outcomes

  1. Global Cognitive Ability (GCA)

    Time frame: Day 0

    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.

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Collaborators

  • National Institute on Aging (NIA)
  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

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

Acronym: PUMA

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Oct 11, 2021
Registry last updated
Aug 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.