CI

At a glance

ClinicalIndex Comparison Record
Early Ph 1Completed· 28 enrolled
Drug / intervention
11C-OMAR +1 moredrug
Likely dose
Cannabis 25 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03204305
NCT03204305Early Ph 1Completed

Brain Imaging of Cannabinoid Receptors in Women

Johns Hopkins University·interventional·Posted Jul 2, 2017·Updated Mar 21, 2023

In Brief

A Early Phase 1 clinical trial evaluating 11C-OMAR and Cannabis for Cannabis Use Disorder and Cannabis Dependence, Continuous. Completed, enrolled 28 participants across 1 site.

Detailed Summary

All participants will be healthy volunteers and all procedures will be completed for research purposes only. Two groups will be recruited, females who use cannabis (marijuana, MJ), and female who do not use cannabis (controls). Female MJ users will be enrolled in a protocol that includes an outpatient drug administration session and a 4-day/3-night inpatient stay on the Johns Hopkins Bayview Clinical Research Unit (CRU). During outpatient visits, MJ users will have an MRI, and complete MJ self-administration and cognitive performance sessions. MJ users will then reside on the CRU,and complete MJ abstinence, and self-report instruments for withdrawal discomfort. A positron emission tomography (PET) scan of brain cannabinoid type 1 receptors will also be completed. Non-users will complete MRI, PET imaging and cognitive testing under an outpatient protocol (no MJ administration).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Early Ph 1CompletedFinished
201820192020202120222023202420252026
First PostedJul 2, 2017
Enrollment StartSep 14, 2017
Primary CompletionMar 31, 2020
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 9 years ago

Interventions

11C-OMARdrug

11C-OMAR is a PET radiotracer that binds to cannabinoid type 1 receptors (CB1R). It is an analog of the CB1R antagonist/inverse agonist rimonabant. 11C-OMAR was developed, synthesized and validated for inhuman use at the Johns Hopkins University PET center.

Cannabisdrug

Cannabis will be administered to cannabis users. Doses include 0 and 25 mg THC.