Back to resultsStress-Reactivity and Cannabis Use in Cannabis-Using Older Adults (PUMA)
Primary Purpose
Cannabis Use
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Trier Social Stress Task (TSST)
Sponsored by
About this trial
This is an interventional screening trial for Cannabis Use
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.
Sites / Locations
- Medical University of South Carolina
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Stress Induction
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05072795
First Posted
September 24, 2021
Last Updated
September 12, 2023
Sponsor
Medical University of South Carolina
Collaborators
National Institute on Aging (NIA), National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT05072795
Brief Title
Stress-Reactivity and Cannabis Use in Cannabis-Using Older Adults
Acronym
PUMA
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
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
November 19, 2021 (Actual)
Primary Completion Date
June 7, 2023 (Actual)
Study Completion Date
June 7, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of South Carolina
Collaborators
National Institute on Aging (NIA), National Institute on Drug Abuse (NIDA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cannabis Use
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
49 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Stress Induction
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Trier Social Stress Task (TSST)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Global Cognitive Ability (GCA)
Description
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.
Time Frame
Day 0 to Day 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreana Benitez, PhD
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Aimee Aimee McRae-Clark, PharmD
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Stress-Reactivity and Cannabis Use in Cannabis-Using Older Adults
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