Early Phase 1
N=43
Brain Imaging of Cannabinoid Receptors
Cannabis Use Disorder · Cannabis Dependence, Continuous
Bottom Line
View on ClinicalTrials.gov: NCT03204305 ↗Enrolled (actual)
43
Serious AEs
0.0%
Results posted
Mar 2023
Primary outcome: Primary: Distribution Volume (VT) — 1.27; 1.54; 1.14; 1.31 mL/cm^3 — p=0.02
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- 11C-OMAR (Drug); Cannabis (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Johns Hopkins University
- Primary completion
- Mar 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Distribution Volume (VT) |
1.27; 1.54; 1.14; 1.31; 1.56; 1.19 | 0.02 sig |
| SECONDARY Peak Change From Baseline Marijuana Withdrawal Discomfort Score |
2.30; 4.80 | 0.03 sig |
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).
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:
- 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.
Data sourced from ClinicalTrials.gov (NCT03204305). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.