Cannabis UsePUMANCT05072795
Stress-Reactivity and Cannabis Use in Cannabis-Using Older Adults
A study testing Trier Social Stress Task (TSST) in people with Cannabis Use, run by Medical University of South Carolina at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Cannabis Use
- What is being tested?
- Trier Social Stress Task (TSST)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Nov 2021to 7 Jun 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: MUSC Specialized Center of Research Excellence (SCORE) on Sex Differences: Stress-Reactivity and Cannabis Use in Cannabis-Using Older Adults
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.
- Conditions
- Cannabis Use
- Being tested
- Trier Social Stress Task (TSST)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trier Social Stress Task (TSST)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Stress Induction | Experimental | Participants completed the Trier Social Stress Test (TSST) Receives: Behavioral: Trier Social Stress Task (TSST) |
| No intervention | No intervention | Participants did not complete the Trier Social Stress Test (TSST). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2021
- Study start19 Nov 2021
- Primary completion7 Jun 2023
- Study completion7 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cannabis UseStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA), National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Andreana Benitez, Medical University of South Carolina
- Investigators
- Andreana Benitez, PhD, Principal investigator, Medical University of South CarolinaAimee Aimee McRae-Clark, PharmD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05072795
- Sponsor's protocol ID
- 00111432
- Other IDs
- 3U54DA016511-19S1
- Acronym
- PUMA
- Status last verified
- Jul 2024
- First submitted
- 24 Sep 2021
- Last updated
- 1 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MUSC Specialized Center of Research Excellence (SCORE) on Sex Differences: Stress-Reactivity and Cannabis Use in Cannabis-Using Older Adults
- ClinicalTrials.gov ID
- NCT05072795
- Acronym / sponsor ID
- PUMA / 00111432
- Conditions
- Cannabis Use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA), National Institute on Drug Abuse (NIDA)
- Study start
- 19 Nov 2021 (actual)
- Primary completion
- 7 Jun 2023 (actual)
- Study completion
- 7 Jun 2023 (actual)
- First posted
- 11 Oct 2021 (actual)
- Results
- Posted 27 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stress Induction | Experimental | Behavioral: Trier Social Stress Task (TSST)Participants completed the Trier Social Stress Test (TSST) |
| No intervention | No intervention | –Participants did not complete the Trier Social Stress Test (TSST). |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (9 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Stress Induction |
Primary outcome
Global Cognitive Ability (GCA)
Time frame: Day 0
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreana Benitez, PhD principal investigator
Medical University of South Carolina
Aimee Aimee McRae-Clark, PharmD principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trier Social Stress Task (TSST) in people with Cannabis Use, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global Cognitive Ability (GCA) (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2024.