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

Medical University of South Carolina (MUSC)

Status: Completed

Conditions: Cannabis Use

Treatments: Behavioral: Trier Social Stress Task (TSST)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05072795

00111432

3U54DA016511-19S1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 47 patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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47 participants in 2 patient groups

Stress Induction

Experimental group

Description:

Participants completed the Trier Social Stress Test (TSST)

Treatment:

Behavioral: Trier Social Stress Task (TSST)

No intervention

No Intervention group

Description:

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