Age-related Cognitive DeclinePhase 1THC-AgingNCT06948136
Acute Effects of THC in Older Adult
A Phase 1 study testing Delta-9-THC Low Dose and Delta-9-THC Medium Dose in people with Age-related Cognitive Decline, run by Yale University at 1 site in United States.
Trial summary
The primary objective of this study is to determine if increasing age confers greater vulnerability to the acute A) cognitive (e.g., memory, attention, psychomotor function), B) subjective (e.g., anxiogenic and rewarding effects), and C) cardiovascular (heart rate and blood pressure), effects of THC in adults > 21… Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Age-related Cognitive Decline
- What is being tested?
- Delta-9-THC Low Dose and Delta-9-THC Medium Dose
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jun 2025to 1 Nov 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
- Ability to provide informed consent
- No history (current or past) of unstable or serious medical, neurological or psychiatric conditions.
- High school education or greater
- No positive pregnancy test and/or lactation/ planning to nurse while in this study
- English speaking
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ashley Schnakenberg Martin, PhD contact
United States1 site, 1 recruiting
- Recruiting
VA Connecticut Healthcare System
West Haven, Connecticut, 06516
Khaled Draghmeh, MD, 203-932-5711 ext. 14525, khaled.draghmeh@yale.edu
About this study
The primary objective of this study is to determine if increasing age confers greater vulnerability to the acute A) cognitive (e.g., memory, attention, psychomotor function), B) subjective (e.g., anxiogenic and rewarding effects), and C) cardiovascular (heart rate and blood pressure), effects of THC in adults > 21 years old. The secondary aims of the study are to explore age-related acute effects of THC on electrophysiological indices of information processing (e.g., auditory steady-state response (ASSR), oddball paradigm [P300], and resting state cortical noise) and to determine age-related differences in the metabolism of THC.
- Conditions
- Age-related Cognitive Decline
- Being tested
- Delta-9-THC Low Dose, Placebo, Delta-9-THC Medium Dose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Delta-9-THC Low DoseDrug
Active Delta-9-THC administered intravenously over 20 minutes.
PlaceboDrug
Small amount of sterile ethanol (1-2 mLs), with no THC, administered intravenously over 20 minutes.
Delta-9-THC Medium DoseDrug
Active Delta-9-THC administered intravenously over 20 minutes
| Study group | Role | What they receive |
|---|---|---|
| Delta-9-THC Very Low Dose | Active comparator | Active delta-9-THC administered intravenously over 20 minutes. Receives: Drug: Delta-9-THC Low Dose |
| Placebo | Placebo comparator | Control: Small amount of alcohol administered intravenously (quarter teaspoon), with no delta-9-THC, over 20 minutes. Receives: Drug: Placebo |
| Delta-9-THC Medium Dose | Active comparator | Active delta-9-THC administered intravenously over 20 minutes. Receives: Drug: Delta-9-THC Medium Dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rey Auditory Verbal Learning Task (RAVLT) total immediate recall
The task consists of 5 trials, an interference list, free delayed recall, and recognition.
Measured: Each test day will be split into two drug administration sessions. The RAVLT will be administered approximately 25 minutes after each drug administration.
Secondary outcomes (1)
Visual Analog Scale (VAS)
Various feeling states will be measured using a self-reported visual analog scale of feeling states (ex: "calm and relaxed", and "tired") associated with drug administration. Subjects will be asked to score the perceived intensity of these feeling states at that moment on a 100 mm line (0 = not at all, 100 = extremely). A higher score reflects a positive response.
Measured: -60 minutes, 20 minutes, 60 minutes, 120 minutes, 170 minutes, 210 minutes, 270 minutes, 300 minutes, 360 minutes, 420 minutes after the start of the initial THC/placebo drug infusion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2025
- Study start6 Jun 2025
- Primary completion1 Nov 2027 (estimated)
- Study completion1 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age-related Cognitive DeclineStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Deepak C. D'Souza, Yale University
- Investigators
- Deepak C D'Souza, MD, Principal investigator, Yale University School of Medicine; VA Connecticut Healthcare SystemAshley Schnakenberg Martin, PhD, Principal investigator, Yale University School of Medicine; VA Connecticut Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06948136
- Sponsor's protocol ID
- 2000038388
- Other IDs
- 1R21DA058138-01A1
- Acronym
- THC-Aging
- Status last verified
- Oct 2026
- First submitted
- 21 Jan 2025
- Last updated
- 9 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of THC in Older Adult
- ClinicalTrials.gov ID
- NCT06948136
- Acronym / sponsor ID
- THC-Aging / 2000038388
- Conditions
- Age-related Cognitive Decline
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 6 Jun 2025 (actual)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 1 Nov 2028 (estimated)
- First posted
- 29 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to determine if increasing age confers greater vulnerability to the acute A) cognitive (e.g., memory, attention, psychomotor function), B) subjective (e.g., anxiogenic and rewarding effects), and C) cardiovascular (heart rate and blood pressure), effects of THC in adults > 21 years old. The secondary aims of the study are to explore age-related acute effects of THC on electrophysiological indices of information processing (e.g., auditory steady-state response (ASSR), oddball paradigm [P300], and resting state cortical noise) and to determine age-related differences in the metabolism of THC.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Delta-9-THC Very Low Dose | Active comparator | Drug: Delta-9-THC Low DoseActive delta-9-THC administered intravenously over 20 minutes. |
| Placebo | Placebo comparator | Drug: PlaceboControl: Small amount of alcohol administered intravenously (quarter teaspoon), with no delta-9-THC, over 20 minutes. |
| Delta-9-THC Medium Dose | Active comparator | Drug: Delta-9-THC Medium DoseActive delta-9-THC administered intravenously over 20 minutes. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Delta-9-THC Low DoseActive Delta-9-THC administered intravenously over 20 minutes. | Drug | Delta-9-THC Very Low Dose |
| PlaceboSmall amount of sterile ethanol (1-2 mLs), with no THC, administered intravenously over 20 minutes. | Drug | Placebo |
| Delta-9-THC Medium DoseActive Delta-9-THC administered intravenously over 20 minutes | Drug | Delta-9-THC Medium Dose |
Primary outcome
Rey Auditory Verbal Learning Task (RAVLT) total immediate recall
Time frame: Each test day will be split into two drug administration sessions. The RAVLT will be administered approximately 25 minutes after each drug administration.
The task consists of 5 trials, an interference list, free delayed recall, and recognition.
1 secondary outcome
Visual Analog Scale (VAS)
Time frame: -60 minutes, 20 minutes, 60 minutes, 120 minutes, 170 minutes, 210 minutes, 270 minutes, 300 minutes, 360 minutes, 420 minutes after the start of the initial THC/placebo drug infusion.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
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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.
Ashley Schnakenberg Martin, PhD contact
Deepak C D'Souza, MD principal investigator
Yale University School of Medicine; VA Connecticut Healthcare System
Ashley Schnakenberg Martin, PhD principal investigator
Yale University School of Medicine; VA Connecticut Healthcare System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Delta-9-THC Low Dose and Delta-9-THC Medium Dose in people with Age-related Cognitive Decline, run by Yale University 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?
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: looking for participants now, as of the sponsor's last update on 9 Oct 2026. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Khaled Draghmeh, MD (203-932-5711 ext. 14525, khaled.draghmeh@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rey Auditory Verbal Learning Task (RAVLT) total immediate recall (time frame: Each test day will be split into two drug administration sessions. The RAVLT will be administered approximately 25 minutes after each drug administration.). 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 9 Oct 2026.