Cannabis UsePhase 1/2NCT05465538
SV2A in Older Adults
A Phase 1/2 study testing [11C]UCB-J PET in people with Cannabis Use, run by Yale University at 1 site in United States.
Trial summary
The aim of the study is to examine the effect of cannabis use on brain synaptic density among older adults using [11C]UCB-J PET imaging. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cannabis Use
- What is being tested?
- [11C]UCB-J PET
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jul 2022to 30 Sep 2027
- Phase
- Phase 1/2
- 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Able to provide informed consent
- Male or female, aged ≥50 years
- No history of significant medical or neurological disease
- BMI ≤ 50
- If woman of childbearing potential, must agree to use an acceptable method of birth control, as determined by the principal investigator, for the duration of the study and up to one month after completion of PET scans
Who cannot join
- Women with a positive pregnancy test or women who are lactating
- Have had exposure to ionizing radiation that in combination with the study tracer would result in a cumulative exposure that exceeds recommended exposure limits;
- History of a bleeding disorder or are currently taking anticoagulants
- Subjects who have donated blood within 8 weeks of the present study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Conneticut Mental Health Center
New Haven, Connecticut, 06519
Khaled Draghmeh, MD, 203-932-5711 ext. 14525, khaled.draghmeh@yale.edu
About this study
Official title: Effect of Cannabis Use on Synaptic Density in Older Adults
The aim of the study is to examine the effect of cannabis use on brain synaptic density among older adults using [11C]UCB-J PET imaging.
- Conditions
- Cannabis Use
- Being tested
- [11C]UCB-J PET
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[11C]UCB-J PETDrug
Single PET scan using the radioligand [11C]UCB-J
| Study group | Role | What they receive |
|---|---|---|
| Cannabis using older adults | Other | Subjects undergo a single PET scan using [11C]UCB-J Receives: Drug: [11C]UCB-J PET |
| Healthy controls | Other | Subjects undergo a single PET scan using [11C]UCB-J Receives: Drug: [11C]UCB-J PET |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hippocampal synaptic density
Measure of synaptic density in the hippocampus
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2022
- Study start6 Jul 2022
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cannabis UseStudies 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 1/2
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 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, MBBS, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05465538
- Sponsor's protocol ID
- 2000032183
- Status last verified
- Oct 2026
- First submitted
- 16 Jul 2022
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cannabis Use on Synaptic Density in Older Adults
- ClinicalTrials.gov ID
- NCT05465538
- Acronym / sponsor ID
- 2000032183
- Conditions
- Cannabis Use
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 6 Jul 2022 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 19 Jul 2022 (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 aim of the study is to examine the effect of cannabis use on brain synaptic density among older adults using [11C]UCB-J PET imaging.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cannabis using older adults | Other | Drug: [11C]UCB-J PETSubjects undergo a single PET scan using [11C]UCB-J |
| Healthy controls | Other | Drug: [11C]UCB-J PETSubjects undergo a single PET scan using [11C]UCB-J |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Able to provide informed consent
- Male or female, aged ≥50 years
- No history of significant medical or neurological disease
- BMI ≤ 50
- If woman of childbearing potential, must agree to use an acceptable method of birth control, as determined by the principal investigator, for the duration of the study and up to one month after completion of PET scans
Key exclusion criteria (4 listed)
- Women with a positive pregnancy test or women who are lactating
- Have had exposure to ionizing radiation that in combination with the study tracer would result in a cumulative exposure that exceeds recommended exposure limits;
- History of a bleeding disorder or are currently taking anticoagulants
- Subjects who have donated blood within 8 weeks of the present study
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 |
|---|---|---|
| [11C]UCB-J PETSingle PET scan using the radioligand [11C]UCB-J | Drug | Cannabis using older adults, Healthy controls |
Primary outcome
Hippocampal synaptic density
Time frame: 1 month
Measure of synaptic density in the hippocampus
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 20 Oct 2026.
- 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.
Deepak C D'Souza, MBBS, MD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing [11C]UCB-J PET in people with Cannabis Use, 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?
The sponsor lists 5 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 20 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Hippocampal synaptic density (time frame: 1 month). 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 20 Oct 2026.