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Brain Imaging of Cannabinoid Receptors

Primary Purpose

Cannabis Use Disorder, Cannabis Dependence, Continuous

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
11C-OMAR
Cannabis
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Cannabis Use Disorder focused on measuring Marijuana, cannabis, cannabinoid receptor

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers
  • Female, healthy adult volunteers who are either MJ users and nonusers (controls)
  • 18-45 years of age
  • serum creatinine and hepatic enzymes (AST, ALT) must be within the normal limits

  • Women of child bearing potential must meet one of the following three criteria:

    1. negative pregnancy test by serum pregnancy test 2 .Following a reliable method of birth control 3. Agreeing to follow a reliable method of birth control during the study and for 1 month following all study procedures

Additional inclusion criteria for MJ users

  • 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.

Sites / Locations

  • Johns Hopkins Bayview Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Cannabis users

Nonuser controls

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Peak Change From Baseline Marijuana Withdrawal Discomfort Score
Marijuana withdrawal discomfort will be self-reported using the marijuana withdrawal checklist, available via PhenXToolkit.org. Items are: depressed mood, irritability, nervousness/anxiety, restlessness, increased aggression, increased anger, violent outbursts, nausea, decreased appetite, stomach pain, shakiness, sweating, sleep difficulty, strange/wild dreams, craving to smoke cannabis, diarrhea/loose stools, dizziness, muscle spasms/aches, hiccups, stuffy nose, feverish feeling, hot flashes, chills, increased appetite, headaches, fatigue/tiredness, yawning, difficulty concentrating, general physical discomfort, and other. Each item is rated as 0=none, 1=mild, 2=moderate, or 3=severe. A sum score is calculated from items that are valid, reliable cannabis withdrawal symptoms (Budney et al, 2003, Journal of Abnormal Psychology,112(3): 393-402). A higher score represents more severe withdrawal. Scores range from 0-36.

Full Information

First Posted
May 30, 2017
Last Updated
March 20, 2023
Sponsor
Johns Hopkins University
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT03204305
Brief Title
Brain Imaging of Cannabinoid Receptors
Official Title
Brain Imaging of Cannabinoid Receptors in Women
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
September 14, 2017 (Actual)
Primary Completion Date
March 31, 2020 (Actual)
Study Completion Date
March 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cannabis Use Disorder, Cannabis Dependence, Continuous
Keywords
Marijuana, cannabis, cannabinoid receptor

7. Study Design

Primary Purpose
Basic Science
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Two groups will be recruited. Female cannabis users and nonusers.
Masking
Participant
Masking Description
Cannabis THC content (dose) is masked for participant
Allocation
Non-Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cannabis users
Arm Type
Active Comparator
Arm Description
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
Arm Title
Nonuser controls
Arm Type
Active Comparator
Arm Description
No cannabis administration. Non-user controls will complete a PET scan where 20 millicuries of 11C-OMAR
Intervention Type
Drug
Intervention Name(s)
11C-OMAR
Other Intervention Name(s)
JHU75528
Intervention Description
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
Intervention Name(s)
Cannabis
Other Intervention Name(s)
Marijuana
Intervention Description
Cannabis will be administered to cannabis users. Doses include 0 and 25 mg THC.
Primary Outcome Measure Information:
Title
Distribution Volume (VT)
Description
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.
Time Frame
Collected during 90-min PET study
Secondary Outcome Measure Information:
Title
Peak Change From Baseline Marijuana Withdrawal Discomfort Score
Description
Marijuana withdrawal discomfort will be self-reported using the marijuana withdrawal checklist, available via PhenXToolkit.org. Items are: depressed mood, irritability, nervousness/anxiety, restlessness, increased aggression, increased anger, violent outbursts, nausea, decreased appetite, stomach pain, shakiness, sweating, sleep difficulty, strange/wild dreams, craving to smoke cannabis, diarrhea/loose stools, dizziness, muscle spasms/aches, hiccups, stuffy nose, feverish feeling, hot flashes, chills, increased appetite, headaches, fatigue/tiredness, yawning, difficulty concentrating, general physical discomfort, and other. Each item is rated as 0=none, 1=mild, 2=moderate, or 3=severe. A sum score is calculated from items that are valid, reliable cannabis withdrawal symptoms (Budney et al, 2003, Journal of Abnormal Psychology,112(3): 393-402). A higher score represents more severe withdrawal. Scores range from 0-36.
Time Frame
Up to 5 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Female, healthy adult volunteers who are either MJ users and nonusers (controls) 18-45 years of age serum creatinine and hepatic enzymes (AST, ALT) must be within the normal limits Women of child bearing potential must meet one of the following three criteria: 1. negative pregnancy test by serum pregnancy test 2 .Following a reliable method of birth control 3. Agreeing to follow a reliable method of birth control during the study and for 1 month following all study procedures Additional inclusion criteria for MJ users 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elise Weerts, Ph.D.
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Bayview Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Brain Imaging of Cannabinoid Receptors

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