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CB1R in Synthetic Psychoactive Cannabinoids (CB1R in Spice)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03539575
Recruitment Status : Recruiting
First Posted : May 29, 2018
Last Update Posted : October 24, 2022
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Yale University

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Drug Dependence Other: [11-C]OMAR Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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
Arms and Interventions
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Arm Intervention/treatment
Synthetic Psychoactive Cannabinoid Users
Synthetic Psychoactive Cannabinoid dependent subjects who are frequent spice/K2 users will receive the radiotracer [11-C]OMAR.
 Other: [11-C]OMAR
The radiotracer, [11-C]OMAR will be administered at no more than 10 micrograms at the beginning of each PET scan.


Outcome Measures
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Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.

  2. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Deepak C D'Souza, M.D. 203-932-5711 ext 2594 deepak.dsouza@yale.edu
Contact: Patrick Skosnik, Ph.D. 203-932-5711 ext 2252 patrick.skosnik@yale.edu

Locations
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United States, Connecticut
Connecticut Mental Health Center Recruiting
New Haven, Connecticut, United States, 06519
Contact    203-974-7775      
Contact    203-974-7540      
Principal Investigator: Deepak C D'Souza, M.D.         
Principal Investigator: Mohini Ranganathan, M.D.         
Principal Investigator: Patrick D Skosnik, Ph.D.         
Sponsors and Collaborators
Yale University
National Institutes of Health (NIH)
National Institute on Drug Abuse (NIDA)
Investigators
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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
More Information
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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT03539575    
Other Study ID Numbers: 1308012514A
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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yale University:
K2
Spice
Synthetic Marijuana
Additional relevant MeSH terms:
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Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders