The Neural Correlates of Cannabis Use (Multimodal)

March 7, 2024 updated by: Rajiv Radhakrishnan, MD, Yale University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

162

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06519
        • Conneticut Mental Health Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Research subjects can be both cannabis-using or non-cannabis using males and females between the ages of 18-65.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Cognition during withdrawal using a computerized battery
Time Frame: 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.
Change in CB1R availability from baseline to 48 hours and 28 days
Changes in brain rhythms measured by Electroencephalography
Time Frame: Change in CB1R availability from baseline to 48 hours and 28 days
Changes in electroencephalographic (EEG) brain rhythms related to information processing.
Change in CB1R availability from baseline to 48 hours and 28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: Patrick Skosnik, PhD, Yale University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2016

Primary Completion (Actual)

April 27, 2022

Study Completion (Actual)

April 27, 2022

Study Registration Dates

First Submitted

December 22, 2016

First Submitted That Met QC Criteria

March 31, 2017

First Posted (Actual)

April 7, 2017

Study Record Updates

Last Update Posted (Actual)

March 12, 2024

Last Update Submitted That Met QC Criteria

March 7, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1308012514
  • 1R01DA040698-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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