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

Cannabis Use Clinical Trial

— PUMA  

Official title:

MUSC Specialized Center of Research Excellence (SCORE) on Sex Differences: Stress-Reactivity and Cannabis Use in Cannabis-Using Older Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05072795
• Other study ID #: 00111432
• Secondary ID: 3U54DA016511-19S
• Status: Completed
• Phase: N/A
• Start date: November 19, 2021
• Est. completion date: June 7, 2023

Study information

• Verified date: September 2023
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: June 7, 2023
• Est. primary completion date: June 7, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cannabis Use
• Marijuana Abuse

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (3)

Lead Sponsor	Collaborator
Medical University of South Carolina	National Institute on Aging (NIA), National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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. Lower z-scores represent a lower level of cognitive function. The investigator will test the hypothesis that women with CUD will have lower GCA scores than men.	Day 0 to Day 8