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

NCT05072795 | Completed Results

• 2 other identifiers: 001114323U54DA016511-19S1
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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.

Conditions

Cannabis Use

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Stress Induction

EXPERIMENTAL

Participants completed the Trier Social Stress Test (TSST)

Behavioral: Trier Social Stress Task (TSST)

No intervention

NO INTERVENTION

Participants did not complete the Trier Social Stress Test (TSST).

Interventions

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.

Stress Induction

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Results Point of Contact

• Title: Dr. Andreana Benitez
• Organization: Medical University of South Carolina

benitez@musc.edu

843-876-8479

Study Officials

• Andreana Benitez, PhD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

• Aimee Aimee McRae-Clark, PharmD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 24, 2021
• First Posted: October 11, 2021
• Study Start: November 19, 2021
• Primary Completion: June 7, 2023
• Study Completion: June 7, 2023
• Last Updated: August 1, 2024
• Results First Posted: June 27, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)