Clinical Trials Logo

Clinical Trial 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).


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03204305
Study type Interventional
Source Johns Hopkins University
Contact
Status Completed
Phase Early Phase 1
Start date September 14, 2017
Completion date March 31, 2020

See also
  Status Clinical Trial Phase
Active, not recruiting NCT05726617 - Avatar Intervention for the Treatment of Cannabis Use Disorder in Patients With Severe Mental Health Disorders N/A
Not yet recruiting NCT04139668 - Vivitrol Treatment for Cannabis Use Disorder Phase 2
Completed NCT01656707 - Adaptive Treatment for Adolescent Cannabis Use Disorders N/A
Completed NCT05005013 - A Teleheath tDCS Approach to Decrease Cannabis Use N/A
Recruiting NCT05292547 - Repetitive Transcranial Magnetic Stimulation to People With Cannabis Use Disorder (SToP-C-rTMS x CUD) N/A
Completed NCT02932215 - Use of a Mobile Health Sensor in an Open Label Trial of Lorcaserin for the Treatment of Cannabis Use Disorder Phase 1
Completed NCT03430050 - Progesterone for Cannabis Withdrawal Early Phase 1
Withdrawn NCT03629106 - Effects of Cannabis Abstinence on Symptomology and Cognition in Bipolar Disorder N/A
Completed NCT03334721 - Gabapentin for Bipolar & Cannabis Use Disorders Phase 2
Recruiting NCT04721353 - Reducing Cannabis Overuse With Prazosin Phase 4
Completed NCT03718520 - The Influence of in Utero Cannabis Exposure on Neonatal Brain Morphology and Structural Connectivity
Completed NCT03624933 - Effects of Cannabis Abstinence on Symptoms and Cognition in Depression N/A
Recruiting NCT05836207 - Rewards for Cannabis Abstinence-study N/A
Not yet recruiting NCT06114212 - Deep Repetitive Transcranial Magnetic Stimulation for Cannabis Use Disorder N/A
Recruiting NCT05855668 - Phenotyping Patients With Alcohol and Cannabis Use Disorders Using the Addictions Neuroclinical Assessment N/A
Recruiting NCT04517474 - Comparing the Spanish Version of CANreduce With or Without Psychological Support and Treatment as Usual, Reducing Cannabis Use. N/A
Recruiting NCT05885542 - SCORE Emerging Adult Cannabis Use & Stress Phase 1/Phase 2
Not yet recruiting NCT06085222 - Evaluation of a Brief Computerized and Smart Phone-based Intervention for Stress in Regular Cannabis Users Phase 1
Completed NCT03056482 - Haloperidol Versus Ondansetron for Cannabis Hyperemesis Syndrome (HaVOC) Phase 4
Not yet recruiting NCT06395389 - A Brief Intervention for Cannabis Use N/A