N/A
N=47
Stress-Reactivity and Cannabis Use in Cannabis-Using Older Adults
Cannabis Use
Bottom Line
View on ClinicalTrials.gov: NCT05072795 ↗Enrolled (actual)
47
Serious AEs
0.0%
Results posted
Jun 2024
Primary outcome: Primary: Global Cognitive Ability (GCA) — -1.99; -0.82 Standard score (Z-score) — p=0.005
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Trier Social Stress Task (TSST) (Behavioral)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Medical University of South Carolina
- Primary completion
- Jun 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Global Cognitive Ability (GCA) |
-1.99; -0.82 | 0.005 sig |
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.
Data sourced from ClinicalTrials.gov (NCT05072795). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.