Brain Imaging of Cannabinoid Receptors

NCT03204305 | Completed Early Phase 1 Results FDA Drug

• 2 other identifiers: IRB00101744R21DA043963
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Cannabis Use Disorder; Cannabis Dependence, Continuous

Keywords

Marijuana; cannabis; cannabinoid receptor

Outcome Measures

Primary Outcomes (1)

• Distribution Volume (VT)

  Distribution Volume (VT) is the quantification of 11C-OMAR binding to the CB1R; Per our statistical plan we examined VT for eight volumes of interest in the brain (ventral striatum, amygdala, putamen, cingulate, globus pallidus, insula, frontal cortex, and hippocampus) as well as the composite VT for the brain. The unit of measure is mL/cm\^3.

  Collected during 90-min PET study

Secondary Outcomes (1)

• Peak Change From Baseline Marijuana Withdrawal Discomfort Score

  Up to 5 days

Study Arms (2)

Cannabis users

ACTIVE COMPARATOR

Smoked Cannabis plant material (0 and 25 mg THC) will be administered to volunteers who are regular cannabis users. Cannabis users will also complete a PET scan where 20 millicurie of 11C-OMAR

Drug: 11C-OMAR; Drug: Cannabis

Nonuser controls

ACTIVE COMPARATOR

No cannabis administration. Non-user controls will complete a PET scan where 20 millicuries of 11C-OMAR

Drug: 11C-OMAR

Interventions

11C-OMAR DRUG

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.

Also known as: JHU75528

Cannabis users; Nonuser controls

Cannabis DRUG

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

Also known as: Marijuana

Cannabis users

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Regular MJ use
• present MJ positive urine
• meet Diagnostic and Statistical Manual, version 5 (DSM-5) criteria for cannabis use disorder (CUD)
• report no MJ use
• present a MJ-negative urine

You may not qualify if:

• \< 5th grade reading level
• Current Diagnostic and Statistical Manual, version 5 (DSM-5) psychiatric disorder;
• Current DSM-5 alcohol or substance use disorder (excluding MJ or nicotine)
• Recent Illicit drug use or positive drug test
• Using MJ under the guidance of MD;
• History of seizures, closed head trauma;
• unstable hypertension;
• conditions preventing magnetic resonance imaging (MRI) such as implanted metal, claustrophobia, or anatomical abnormalities (e.g., enlarged ventricles, brain lesions);
• Use of medications or herbal supplements which may be counter indicated as determined by study physician
• Have had exposure to ionizing radiation that in combination with the study's estimated radiation exposure would result in a cumulative exposure that exceeds recommended exposure limits of 5 rem per year.
• Presence or history of drug allergy, or allergic disease diagnosed and treated by a physician.
• any serious medical condition in whom participation is contraindicated.

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location

MeSH Terms

Conditions

Marijuana Abuse

Interventions

4-cyano-1-(2,4-dichlorophenyl)-5-(4-methoxyphenyl)-N-(piperidin-1-yl)-1H-pyrazole-3-carboxamide; nabiximols

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. Elise M. Weerts, PhD, Professor
• Organization: Johns Hopkins School of Medicine

eweerts@jhmi.edu

443-550-2781

Study Officials

• Elise Weerts, Ph.D.

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Cannabis THC content (dose) is masked for participant
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two groups will be recruited. Female cannabis users and nonusers.

Study Record Dates

• First Submitted: May 30, 2017
• First Posted: July 2, 2017
• Study Start: September 14, 2017
• Primary Completion: March 31, 2020
• Study Completion: March 31, 2020
• Last Updated: March 21, 2023
• Results First Posted: March 21, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)