The Neural Correlates of Cannabis Use

Completed

• Conditions: Cannabis Dependence; Healthy
• Interventions: Drug: [11-C]OMAR

• Registration Number: NCT03104257
• Lead Sponsor: Yale University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2016-12
• Study First Submitted: 2016-12-22
• Study First Submitted QC: 2017-03-31
• Study First Posted: 2017-04-07
• Primary Completion: 2022-04-27
• Study Completion: 2022-04-27
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-07
• Last Update Posted: 2024-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 162

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

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Exclusion Criteria

• MRI metal exclusions and claustrophobia
• Education completed is less than 12 years

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cannabis Dependent Subjects	[11-C]OMAR	Subjects who are frequent cannabis users
Healthy Controls	[11-C]OMAR	Subjects with no current cannabis use

Primary Outcome Measures

Name	Time	Method
CB1R availability using [11-C]OMAR PET imaging	Change in CB1R availability from baseline to 48 hours and 28 days	Change in CB1R availability (e.g. volume distribution).

Secondary Outcome Measures

Name	Time	Method
Changes in Cognition during withdrawal using a computerized battery	Change in CB1R availability from baseline to 48 hours and 28 days	Changes in cognitive functions such as attention, memory, motor functioning, and processing speed.
Changes in brain rhythms measured by Electroencephalography	Change in CB1R availability from baseline to 48 hours and 28 days	Changes in electroencephalographic (EEG) brain rhythms related to information processing.

Trial Locations

Locations (1)

Conneticut Mental Health Center; 🇺🇸 New Haven, Connecticut, United States