Trial Outcomes & Findings for Stress-Reactivity and Cannabis Use in Cannabis-Using Older Adults (NCT NCT05072795)

Last Updated: 2024-08-01

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

47 participants

Primary outcome timeframe

Day 0

Results posted on

2024-08-01

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	47
Overall Study COMPLETED	42
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Lost to Follow-up	5

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Stress Induction n=47 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	39 Participants n=5 Participants
Age, Categorical >=65 years	8 Participants n=5 Participants
Age, Continuous	61.11 years STANDARD_DEVIATION 5.6 • n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants
Sex: Female, Male Male	26 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	45 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	42 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	47 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 0

Population: Hypothesis was that women with CUD will have lower GCA scores than men.

Outcome measures

Outcome measures
Measure	Independent of Intervention n=47 Participants No intervention
Global Cognitive Ability (GCA) Male	-1.99 Standard score (Z-score) Standard Deviation 1.31
Global Cognitive Ability (GCA) Female	-0.82 Standard score (Z-score) Standard Deviation 1.37

Adverse Events

Stress Induction

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Andreana Benitez

Medical University of South Carolina

Phone: 843-876-8479

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place