CB1R in Spice: CB1R in Synthetic Psychoactive Cannabinoids

• Sponsor: Yale University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03539575
• Collaborator: National Institutes of Health (NIH) (NIH), National Institute on Drug Abuse (NIDA) (NIH)
• Enrollment: 15
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 55
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• Anticipated 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
• Anticipated Primary Completion Date: Dec 1, 2022
• Anticipated Study Completion Date: Dec 1, 2022

Arms and Interventions

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.	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

Primary Outcome Measures

1. Positron Emission Tomography (PET Imaging) [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 [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 [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

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Connecticut Mental Health Center	New Haven	Connecticut	United States	06519

Sponsors and Collaborators

• Yale University
• National Institutes of Health (NIH)
• National Institute on Drug Abuse (NIDA)

Investigators

• 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yale University
• ClinicalTrials.gov Identifier: NCT03539575
• Other Study ID Numbers: 1308012514A; 1R21DA041580-01A1
• First Posted: May 29, 2018
• Last Update Posted: Oct 18, 2021
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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: Substance-Related Disorders

Study Results

No Results Posted as of Oct 18, 2021