- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03539575
CB1R in Synthetic Psychoactive Cannabinoids (CB1R in Spice)
April 23, 2026 updated by: Deepak C. D'Souza, Yale University
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.
Study Overview
Study Type
Interventional
Enrollment (Estimated)
15
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Connecticut
-
New Haven, Connecticut, United States, 06519
- Connecticut Mental Health Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion:
- Able to provide written consent
- Age 18-55
- Current Synthetic Psychoactive Cannabinoids consumption
Exclusion:
- MRI metal exclusions and claustrophobia
- Education completed is less than 12 years
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Synthetic Psychoactive Cannabinoid Users
Synthetic Psychoactive Cannabinoid dependent subjects who are frequent spice/K2 users will receive the radiotracer [11-C]OMAR.
|
The radiotracer, [11-C]OMAR will be administered at no more than 10 micrograms at the beginning of each PET scan.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
Change in CB1R availability from baseline throughout one test day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
CogState Battery
Time Frame: Change in CB1R availability from baseline throughout one test day
|
2. Changes in Cognition during withdrawal using a computerized battery Changes in cognitive functions such as attention, memory, motor functioning, and processing speed.
|
Change in CB1R availability from baseline throughout one test day
|
|
Electroencephalogram
Time Frame: Change in CB1R availability from baseline throughout one test day
|
3. Changes in brain rhythms measured by Electroencephalography Changes in electroencephalographic (EEG) brain rhythms related to information processing.
|
Change in CB1R availability from baseline throughout one test day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Mohini Ranganathan, M.D., Yale University
- Principal Investigator: Deepak C D'Souza, M.D., Yale University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2018
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2026
Study Registration Dates
First Submitted
March 6, 2018
First Submitted That Met QC Criteria
May 16, 2018
First Posted (Actual)
May 29, 2018
Study Record Updates
Last Update Posted (Actual)
April 29, 2026
Last Update Submitted That Met QC Criteria
April 23, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1308012514A
- 1R21DA041580-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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