Brain Imaging of Cannabinoid Receptors

NCT ID: NCT03204305

Last Updated: 2023-03-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-14
• Study Completion Date: 2020-03-31

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).

Detailed Description

The primary goals of this project are to examine whether use of cannabis alters brain cannabinoid type 1 receptor (CB1R) availability in females, and if severity of cannabis withdrawal is correlated with CB1 receptor availability. CB1R are widely distributed in the human brain and can be quantified using PET imaging with the radiotracer 11C-OMAR (Carbon-11-OMAR). The effects MJ use on brain CB1R have not been studied in females. The current study will enroll 10 female MJ users in an inpatient protocol that includes administration of smoked MJ, followed by monitored abstinence with daily behavioral assessments, and PET imaging with 11C-OMAR. PET data will collected in 10 matched controls for comparison. The proposed study is an important first step to determine whether localized CB1R changes in female MJ users help explain, and provide a neurobiological target for intervention. Results will increase knowledge of cannabinoid mechanisms of cannabis use and severity of dependence in females, an understudied population.

Conditions

Cannabis Use Disorder; Cannabis Dependence, Continuous

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Cannabis users

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

Group Type: ACTIVE_COMPARATOR

11C-OMAR

Intervention Type: 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.

Cannabis

Intervention Type: DRUG

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

Nonuser controls

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

Group Type: ACTIVE_COMPARATOR

11C-OMAR

Intervention Type: 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.

Interventions

11C-OMAR

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.

Intervention Type: DRUG

Cannabis

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

Intervention Type: DRUG

Other Intervention Names

JHU75528; Marijuana

Eligibility Criteria

Inclusion Criteria

• Regular MJ use
• present MJ positive urine
• meet Diagnostic and Statistical Manual, version 5 (DSM-5) criteria for cannabis use disorder (CUD)

Additional inclusion non-users

• report no MJ use
• present a MJ-negative urine

Exclusion Criteria

• < 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elise Weerts, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

R21DA043963

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00101744

Identifier Type: -

Identifier Source: org_study_id