Multimodal: The Neural Correlates of Cannabis Use

Sponsor

Yale University (Other)

Overall Status

Recruiting

CT.gov ID

NCT03104257

Collaborator

National Institute on Drug Abuse (NIDA) (NIH)

Enrollment

Location

Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cannabis Dependence Healthy	Drug: [11-C]OMAR

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 Design

Study Type:

Observational

Anticipated Enrollment :

37 participants

Observational Model:

Other

Time Perspective:

Other

Official Title:

The Neural Correlates of Cannabis Use

Study Start Date :

Dec 1, 2016

Anticipated Primary Completion Date :

Jun 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Cannabis Dependent Subjects Subjects who are frequent cannabis users	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.
Healthy Controls Subjects with no current cannabis use	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.

Arm

Intervention/Treatment

Cannabis Dependent Subjects

Subjects who are frequent cannabis users

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.

Healthy Controls

Subjects with no current cannabis use

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.

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

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

Sponsors and Collaborators

Yale University
National Institute on Drug Abuse (NIDA)

Investigators

Principal Investigator: Patrick Skosnik, PhD, Yale University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Patrick D. Skosnik, Associate Professor of Psychiatry, Yale University

ClinicalTrials.gov Identifier:

NCT03104257

Other Study ID Numbers:

1308012514
1R01DA040698-01A1

First Posted:

Apr 7, 2017

Last Update Posted:

Feb 11, 2022

Last Verified:

Jan 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Keywords provided by Patrick D. Skosnik, Associate Professor of Psychiatry, Yale University

Healthy Control, Cannabis, Dependence

Additional relevant MeSH terms:

Marijuana Abuse

Study Results

No Results Posted as of Feb 11, 2022