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NCT03104257 Clinical Trial

The Neural Correlates of Cannabis Use

Healthy Clinical Trial

— Multimodal  

Official title:
The Neural Correlates of Cannabis Use

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03104257
Other study ID # 1308012514
Secondary ID 1R01DA040698-01A
Status Completed
Phase
First received
Last updated
Start date December 2016
Est. completion date April 27, 2022

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

Clinical Trial Summary

The purpose of this research study is to determine the temporal course of recovery of CB1R availability and neural oscillations, in cannabis-dependent individuals at baseline, following 48 hour confirmed inpatient abstinence and after four weeks confirmed abstinence. This research will also examine associations between CB1R availability, neural oscillations and cognitive function.

Description:

The purpose of this research study is to determine the temporal course of recovery of CB1R availability and neural oscillations, in cannabis-dependent individuals at baseline, following 48 hour confirmed inpatient abstinence and after four weeks confirmed outpatient abstinence (confirmed by tracking creatinine adjusted urine THC-COOH levels). This research will also examine associations between CB1R availability, neural oscillations and cognitive function using [11-C]OMAR PET imaging and electroencephalography.

Recruitment information / eligibility
Status Completed
Enrollment 162
Est. completion date April 27, 2022
Est. primary completion date April 27, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria: Cannabis Dependent Subjects - Current cannabis consumption - Willing to abstain from cannabis use for four weeks Inclusion Criteria for Healthy Controls - No current cannabis consumption Exclusion Criteria: - MRI metal exclusions and claustrophobia - Education completed is less than 12 years

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• [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 Conneticut Mental Health Center New Haven Connecticut

Sponsors (2)
Lead Sponsor Collaborator
Yale University National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary CB1R availability using [11-C]OMAR PET imaging Change in CB1R availability (e.g. volume distribution). Change in CB1R availability from baseline to 48 hours and 28 days
Secondary 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 to 48 hours and 28 days
Secondary Changes in brain rhythms measured by Electroencephalography Changes in electroencephalographic (EEG) brain rhythms related to information processing. Change in CB1R availability from baseline to 48 hours and 28 days
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