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NCT03539575 Clinical Trial

CB1R in Synthetic Psychoactive Cannabinoids

Drug Dependence Clinical Trial

— CB1R in Spice  

Official title:
CB1R Availability in Synthetic Psychoactive Cannabinoid Users

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03539575
Other study ID # 1308012514A
Secondary ID 1R21DA041580-01A
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date May 1, 2018
Est. completion date December 2024

Study information
Verified date January 2024
Source Yale University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 15
Est. completion date December 2024
Est. primary completion date December 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
United States Connecticut Mental Health Center New Haven Connecticut

Sponsors (3)
Lead Sponsor Collaborator
Yale University National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Positron Emission Tomography (PET Imaging) 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 CogState Battery 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
Secondary Electroencephalogram 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
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