NCT03104257

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
162

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2016

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

December 22, 2016

Completed
4 months until next milestone

First Posted

Study publicly available on registry

April 7, 2017

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 27, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 27, 2022

Completed
Last Updated

October 21, 2025

Status Verified

October 1, 2025

Enrollment Period

5.4 years

First QC Date

December 22, 2016

Last Update Submit

October 17, 2025

Conditions

Keywords

Healthy Control, Cannabis, Dependence

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Changes in Cognition during withdrawal using a computerized battery

    Change in CB1R availability from baseline to 48 hours and 28 days

  • Changes in brain rhythms measured by Electroencephalography

    Change in CB1R availability from baseline to 48 hours and 28 days

Study Arms (2)

Cannabis Dependent Subjects

Subjects who are frequent cannabis users

Drug: [11-C]OMAR

Healthy Controls

Subjects with no current cannabis use

Drug: [11-C]OMAR

Interventions

The radiotracer, \[11-C\]OMAR will be administered at no more than 10 micrograms at the beginning of each PET scan.

Cannabis Dependent SubjectsHealthy Controls

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Current cannabis consumption
  • Willing to abstain from cannabis use for four weeks
  • No current cannabis consumption

You may not qualify if:

  • Education completed is less than 12 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Conneticut Mental Health Center

New Haven, Connecticut, 06519, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

When specimens and information are stored, researchers are careful to try to protect your identity from discovery by others. Samples and information will receive a unique code. Other researchers will only receive coded samples and information, and will not be able to link the code to subjects. Strict security safeguards are in place to reduce the chance of misuse or unplanned release of information.

MeSH Terms

Conditions

Marijuana Abuse

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Mohini Ranganathan, MD

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 22, 2016

First Posted

April 7, 2017

Study Start

December 1, 2016

Primary Completion

April 27, 2022

Study Completion

April 27, 2022

Last Updated

October 21, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations