Clinical trial NCT05072795: Stress-Reactivity and Cannabis Use in Cannabis-Using Older Adults
Official title: MUSC Specialized Center of Research Excellence (SCORE) on Sex Differences: Stress-Reactivity and Cannabis Use in Cannabis-Using Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cannabis Use
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
name: National Institute on Drug Abuse (NIDA)
First posted: 2021-10-11
Enrollment: 47
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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.


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.

Primary outcomes:
measure: Global Cognitive Ability (GCA)
timeFrame: Day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Andreana Benitez, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical University of South Carolina
name: Aimee Aimee McRae-Clark, PharmD
role: PRINCIPAL_INVESTIGATOR
References: