Drug DependenceCB1R in SpiceNCT03539575
CB1R in Synthetic Psychoactive Cannabinoids
A study testing [11-C]OMAR in people with Drug Dependence, run by Yale University at 1 site in United States.
Trial summary
The purpose of this research study is to determine whether the CB1R availability is lower in synthetic psychoactive cannabinoid subjects using the most widely available synthetic psychoactive cannabinoids at the time the study is initiated. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Drug Dependence
- What is being tested?
- [11-C]OMAR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2018to Dec 2026
- Phase
- Interventional
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Able to provide written consent
- Age 18-55
- Current Synthetic Psychoactive Cannabinoids consumption
Who cannot join
- MRI metal exclusions and claustrophobia
- Education completed is less than 12 years
Trial locations and contacts
1 site in 1 country.
United States1 site
Connecticut Mental Health Center
New Haven, Connecticut, 06519
About this study
Official title: CB1R Availability in Synthetic Psychoactive Cannabinoid Users
The purpose of this research study is to determine whether the CB1R availability is lower in synthetic psychoactive cannabinoid subjects using the most widely available synthetic psychoactive cannabinoids at the time the study is initiated.
- Conditions
- Drug Dependence
- Being tested
- [11-C]OMAR
- Keywords
- K2, Spice, Synthetic Marijuana
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[11-C]OMAROther
The radiotracer, [11-C]OMAR will be administered at no more than 10 micrograms at the beginning of each PET scan.
| Study group | Role | What they receive |
|---|---|---|
| Synthetic Psychoactive Cannabinoid Users | Other | Synthetic Psychoactive Cannabinoid dependent subjects who are frequent spice/K2 users will receive the radiotracer [11-C]OMAR. Receives: Other: [11-C]OMAR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positron Emission Tomography (PET Imaging)
CB1R availability using [11-C]OMAR PET imaging Change in CB1R availability (e.g. volume distribution).
Measured: Change in CB1R availability from baseline throughout one test day
Secondary outcomes (2)
CogState Battery
- Changes in Cognition during withdrawal using a computerized battery Changes in cognitive functions such as attention, memory, motor functioning, and processing speed.
Measured: Change in CB1R availability from baseline throughout one test day
Electroencephalogram
- Changes in brain rhythms measured by Electroencephalography Changes in electroencephalographic (EEG) brain rhythms related to information processing.
Measured: Change in CB1R availability from baseline throughout one test day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2018
- Study start1 May 2018
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug DependenceStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Deepak C. D'Souza, Yale University
- Investigators
- Deepak C D'Souza, M.D., Principal investigator, Yale UniversityMohini Ranganathan, M.D., Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03539575
- Sponsor's protocol ID
- 1308012514A
- Other IDs
- 1R21DA041580-01A1
- Acronym
- CB1R in Spice
- Status last verified
- Apr 2026
- First submitted
- 6 Mar 2018
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CB1R Availability in Synthetic Psychoactive Cannabinoid Users
- ClinicalTrials.gov ID
- NCT03539575
- Acronym / sponsor ID
- CB1R in Spice / 1308012514A
- Conditions
- Drug Dependence
- Keywords
- K2, Spice, Synthetic Marijuana
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA)
- Study start
- 1 May 2018 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 29 May 2018 (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 purpose of this research study is to determine whether the CB1R availability is lower in synthetic psychoactive cannabinoid subjects using the most widely available synthetic psychoactive cannabinoids at the time the study is initiated.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Synthetic Psychoactive Cannabinoid Users | Other | Other: [11-C]OMARSynthetic Psychoactive Cannabinoid dependent subjects who are frequent spice/K2 users will receive the radiotracer [11-C]OMAR. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Able to provide written consent
- Age 18-55
- Current Synthetic Psychoactive Cannabinoids consumption
Key exclusion criteria (2 listed)
- MRI metal exclusions and claustrophobia
- Education completed is less than 12 years
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 |
|---|---|---|
| [11-C]OMARThe radiotracer, [11-C]OMAR will be administered at no more than 10 micrograms at the beginning of each PET scan. | Other | Synthetic Psychoactive Cannabinoid Users |
Primary outcome
Positron Emission Tomography (PET Imaging)
Time frame: Change in CB1R availability from baseline throughout one test day
CB1R availability using [11-C]OMAR PET imaging Change in CB1R availability (e.g. volume distribution).
2 secondary outcomes
CogState Battery
Time frame: Change in CB1R availability from baseline throughout one test day
Electroencephalogram
Time frame: Change in CB1R availability from baseline throughout one test day
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 29 Apr 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. This study is not recruiting at the moment.
Deepak C D'Souza, M.D. principal investigator
Yale University
Mohini Ranganathan, M.D. 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 study testing [11-C]OMAR in people with Drug Dependence, 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 3 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 29 Apr 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.
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?
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?
Positron Emission Tomography (PET Imaging) (time frame: Change in CB1R availability from baseline throughout one test day). 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 29 Apr 2026.