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

NCT ID: NCT05072795

Last Updated: 2024-08-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-19
• Study Completion Date: 2023-06-07

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Stress Induction

Participants completed the Trier Social Stress Test (TSST)

Group Type: EXPERIMENTAL

Trier Social Stress Task (TSST)

Intervention Type: 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.

No intervention

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility 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 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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Andreana Benitez

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andreana Benitez, PhD

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Aimee Aimee McRae-Clark, PharmD

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Locations

Medical University of South Carolina

Charleston, South Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

3U54DA016511-19S1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

00111432

Identifier Type: -

Identifier Source: org_study_id