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| ID | Type | Description | Link |
|---|---|---|---|
| 3U54DA016511-19S1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stress Induction | Experimental | Participants completed the Trier Social Stress Test (TSST) |
|
| No intervention | No Intervention | Participants did not complete the Trier Social Stress Test (TSST). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trier Social Stress Task (TSST) | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. A Z-score of 0 represents the population mean with positive scores indicating a higher level of cognitive function and negative scores indicating a lower level of cognitive function than the mean. The investigator will test the hypothesis that women with CUD will have lower GCA scores than men. | Day 0 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andreana Benitez, PhD | Medical University of South Carolina | Principal Investigator |
| Aimee Aimee McRae-Clark, PharmD | Medical University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
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There was one participant group (N=47). All participants completed cognitive testing on Day 0 and a stress intervention on Day 8.
Cognition was assessed independently of the stress intervention and is the primary outcome. N=47 completed the cognition assessments, which we listed as the non-intervention group. Stress intervention was not a primary outcome and is not reported in results section. N=45 completed the Stress Induction and are listed below.
Participants were recruited between Oct 2021 and May 2023 through community advertisements.
The first participant was enrolled on 11/19/2021 and the last participant was enrolled on 5/18/2023.
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| ID | Title | Description |
|---|---|---|
| FG000 | Stress Induction | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Stress Induction | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. A Z-score of 0 represents the population mean with positive scores indicating a higher level of cognitive function and negative scores indicating a lower level of cognitive function than the mean. The investigator will test the hypothesis that women with CUD will have lower GCA scores than men. | Hypothesis was that women with CUD will have lower GCA scores than men. | Posted | Mean | Standard Deviation | Standard score (Z-score) | Day 0 |
|
14 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Stress Induction | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Andreana Benitez | Medical University of South Carolina | 843-876-8479 | benitez@musc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 18, 2023 | May 2, 2024 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 1, 2023 | Aug 7, 2023 | ICF_000.pdf |
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|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units | Counts |
|---|---|
| Participants |
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| 0 |
| 47 |
| 0 |
| 47 |
| 0 |
| 47 |
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