CB1R in Synthetic Psychoactive Cannabinoids (CB1R in Spice)
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|ClinicalTrials.gov Identifier: NCT03539575|
Recruitment Status : Recruiting
First Posted : May 29, 2018
Last Update Posted : October 24, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Drug Dependence||Other: [11-C]OMAR||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||CB1R Availability in Synthetic Psychoactive Cannabinoid Users|
|Actual Study Start Date :||May 1, 2018|
|Estimated Primary Completion Date :||December 2023|
|Estimated Study Completion Date :||December 2023|
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.
- 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).
- 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.
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years to 55 Years (Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- Able to provide written consent
- Age 18-55
- Current Synthetic Psychoactive Cannabinoids consumption
- MRI metal exclusions and claustrophobia
- Education completed is less than 12 years
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03539575
|Contact: Deepak C D'Souza, M.D.||203-932-5711 ext email@example.com|
|Contact: Patrick Skosnik, Ph.D.||203-932-5711 ext firstname.lastname@example.org|
|United States, Connecticut|
|Connecticut Mental Health Center||Recruiting|
|New Haven, Connecticut, United States, 06519|
|Principal Investigator: Deepak C D'Souza, M.D.|
|Principal Investigator: Mohini Ranganathan, M.D.|
|Principal Investigator: Patrick D Skosnik, Ph.D.|
|Principal Investigator:||Deepak C D'Souza, M.D.||Yale University|
|Principal Investigator:||Mohini Ranganathan, M.D.||Yale University|
|Principal Investigator:||Patrick D Skosnik, Ph.D.||Yale University|
|Responsible Party:||Yale University|
|Other Study ID Numbers:||
1R21DA041580-01A1 ( U.S. NIH Grant/Contract )
|First Posted:||May 29, 2018 Key Record Dates|
|Last Update Posted:||October 24, 2022|
|Last Verified:||October 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|