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Trial record 42 of 95 for:    Recruiting, Not yet recruiting, Active, not recruiting Studies | marijuana | United States

Brain Imaging of Cannabinoid Receptors

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ClinicalTrials.gov Identifier: NCT03204305
Recruitment Status : Recruiting
First Posted : July 2, 2017
Last Update Posted : February 20, 2019
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Johns Hopkins University

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).

Condition or disease Intervention/treatment Phase
Cannabis Use Disorder Cannabis Dependence, Continuous Drug: 11C-OMAR Drug: Cannabis Early Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Two groups will be recruited. Marijuana users and nonusers.
Masking: Single (Participant)
Masking Description: marijuana THC content (dose) is masked for participant
Primary Purpose: Basic Science
Official Title: Brain Imaging of Cannabinoid Receptors in Women
Actual Study Start Date : September 14, 2017
Estimated Primary Completion Date : May 31, 2019
Estimated Study Completion Date : May 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana

Arm Intervention/treatment
Active Comparator: 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
Drug: 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.
Other Name: JHU75528

Drug: Cannabis
Cannabis will be administered to cannabis users. Doses include 0 and 25 mg THC.
Other Name: Marijuana

Active Comparator: Nonuser controls
No cannabis administration. Non-user controls will complete a PET scan where 20 millicuries of 11C-OMAR
Drug: 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.
Other Name: JHU75528




Primary Outcome Measures :
  1. Non-displaceable binding potential (BPND) [ Time Frame: Collected during 90-min PET study; up to 1 day ]
    quantification of 11C-OMAR binding to the CB1R


Secondary Outcome Measures :
  1. Peak Marijuana Withdrawal Discomfort Score [ Time Frame: Cannabis users only ; Up to 5 days, group data analysis year 2 ]
    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, and general physical discomfort. Participants can describe symptoms not listed on the questionnaire (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).



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03204305


Contacts
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Contact: Alisha Eversole 4105505254 aeverso1@jhmi.edu
Contact: Elise Weerts, Ph.D. 4105502781 eweerts@jmhi.edu

Locations
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United States, Maryland
Johns Hopkins Bayview Medical Center Recruiting
Baltimore, Maryland, United States, 21224
Contact: Alisha Eversole    410-550-5254    aeverso1@jhmi.edu   
Contact: Elise Weerts, Ph.D.    410-550-2781    eweerts@jhmi.edu   
Sponsors and Collaborators
Johns Hopkins University
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Elise Weerts, Ph.D. Johns Hopkins University

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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03204305     History of Changes
Other Study ID Numbers: IRB00101744
R21DA043963 ( U.S. NIH Grant/Contract )
First Posted: July 2, 2017    Key Record Dates
Last Update Posted: February 20, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Johns Hopkins University:
Marijuana
cannabis
cannabinoid receptor

Additional relevant MeSH terms:
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Marijuana Abuse
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders