Imaging Cannabinoid CB1 Receptors in Alcohol Dependence

Completed

Conditions studied: Alcoholism

In brief

The cannabinoid type 1 (CB1) receptor is a protein found in the brain that is involved with the effects of marijuana; it may also play a role in the effects of alcohol dependence and withdrawal. Earlier animal studies have shown that although long-term alcohol use decreases the number of CB1 receptors in the brain, the number returns to normal after alcohol use stops. This study will use positron emission tomography (PET) and magnetic resonance imaging (MRI) scans to trace a radioactive chemical called \[11C\]MePPEP, which can locate and measure the number of CB1 receptors in the brain. Researchers will study the CB1 receptors in the brains of people with alcohol dependence, and compare the results to the CB1 receptors in the brains of people without alcohol dependence. The results of this study will be used to further research into appropriate treatment procedures for alcohol dependence. This study will include 30 men with alcohol dependence and 50 men without alcohol dependence. All of the men must be between 18 and 65 years of age. Participants in both groups must not have any medical conditions that will prevent them from undergoing PET or MRI scans. For the PET scan, participants will be injected with a small amount of \[11C\]MePPEP and will then be brought to the PET scanner. The scan will take between 3 and 4 hours, but participants will be allowed to take breaks over the course of the scan. The MRI scan will not require any injections and will take approximately 1 hour to complete. Participants without alcohol dependence will make three visits to the National Institutes of Health Clinical Center. Blood and urine samples will be taken during one visit, and participants will arrange to have an MRI scan on one visit and a PET scan on the other visit, in whichever order they prefer. Participants with alcohol dependence will undergo two PET scans: the first will be performed between 3 and 7 days after the participant last consumed alcohol, and the second will be performed approximately 2 to 4 weeks after the first scan (with no alcohol consumption permitted in the interval). Participants will alcohol dependence will also undergo an MRI scan and will provide blood and urine samples.

Key facts

Study ID

NCT00816439

Run by

National Institute of Mental Health (NIMH)

People needed

101

Starts

2008-12-29

Expected to finish

2014-08-28

Last updated by the study team

2018-07-05

Who can join

Age: 18 and older, up to 65. Sex: male. Healthy volunteers: accepted.

You may not qualify if…

• ALCOHOL DEPENDENT PATIENTS:
• Any serious medical condition as judged by the investigator in consultation with the attending physician in the NIAAA program.
• Clinically significant coagulopathies or laboratory abnormalities other than those related to alcohol dependence.
• Past or present diagnosis of schizophrenia, bipolar illness or any other psychotic disorder; any current disorder that has required psychoactive medication (other than oxazepam) within the preceding 28-day period (42 days for fluoxetine). 3. Oxazepam is a relatively short acting benzodiazepine and is used clinically during alcohol withdrawal. Any present substance abuse other than alcohol.
• Positive test for HIV.
• Metallic foreign bodies that would be affected by the MRI scanner magnet, or fear of enclosed spaces likely to make the subject unable to undergo an MRI scan.
• Head trauma resulting in a period of unconsciousness lasting longer than 1 hour.
• History of fetal alcohol syndrome or other neurodevelopmental disorder.
• History of seizures, other than in childhood and related to fever.
• Recent exposure to radiation (i.e., PET from other research) which when combined with this study would be above the allowable limits.
• Positive urine drug screen.
• Inability to lie flat on camera bed for about 2.5 h
• HEALTHY SUBJECTS:
• Any current Axis I diagnosis; and any lifetime diagnosis of drug abuse or dependence.
• Clinically significant laboratory abnormalities.
• Recent heavy use of alcohol. That is, subjects must have an alcohol audit score of less than or equal to 9. In addition, subjects must agree not to consume any alcohol in the three days prior to the PET scan.
• Psychotropic medication use (including benzodiazepines and illicit drugs) during the 28 days (42 day for fluoxetine) prior to the PET scan.
• Serious medical problems.
• Positive test for HIV.
• Metallic foreign bodies that would be affected by the MRI magnet, or fear of enclosed spaces likely to make the subject unable to undergo an MRI scan.
• Head trauma resulting in a period of unconsciousness lasting longer than 10 minutes.
• History of fetal alcohol syndrome or other neurodevelopmental disorder.
• History of seizures, other than in childhood and related to fever.
• Recent exposure to radiation (i.e., PET from other research) which when combined with this study would be above the allowable limits.
• Positive urine drug screen.

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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