Dopamine Release in the Human Brain Following Alcohol Administration

Center for Addiction and Mental Health (CAMH)

Status and phase

Completed

Phase 1

Conditions

Heavy Drinking

Treatments

Drug: alcoholic beverage

Drug: non-alcoholic beverage

Study type

Interventional

Funder types

Other

Identifiers

NCT01638364

041/2012

Details and patient eligibility

About

The purpose of this study is to examine whether there is an increase in dopamine levels in the human striatum following an oral administration of alcohol, as has been evidenced in animal models. This will be a Positron Emission Tomography (PET) study using the radiotracer, [11C]-(+)-PHNO (11C]-( + )-4-propyl- 3,4,4a,5,6,10b-hexahydro-2H-naphtho[1,2-b][1,4]oxazin-9-ol).

Full description

This will be a within subjects study in 8 heavy drinkers ages 21-45. The within factors will be PET scans following an alcoholic beverage and following a non-alcoholic beverage. Participants will also have a baseline session prior to the scans where they will complete various cognitive tasks and questionnaires. During each PET scan, subjective drug effects as well as heart rate, blood pressure, blood alcohol content and cortisol levels will be collected. The change in PHNO binding potential between the two scan conditions will be the primary outcome measure.

Enrollment

8 patients

Sex

All

Ages

21 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy males and females of any ethnic origin between 21 and 45 years old.
Reported consumption of at least two heavy drinking episodes (according to the National Institute on Alcohol Abuse and Alcoholism (NIAAA) criterion of 5 drinks for males or 4 for females) in the past 30 days prior to assessment.
Willing and capable to provide written informed consent
Good command of the English language

Exclusion criteria

Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) diagnosis of alcohol dependence; receiving treatment for alcohol dependence
Taking medications or have any medical condition for which alcohol is contraindicated
Any medical condition requiring immediate investigation or treatment
Previous head trauma/neurological condition such as clinically significant history of seizure disorder, a history of clinically significant head trauma (i.e., concussion resulting in clinically significant loss of consciousness) or past intracranial surgery
Beck Depression Inventory score >16
Current active or past suicidal ideation
Pregnancy tested by urine and blood screen each PET study day or lactation
Current DSM-IV diagnosis of any Axis I psychiatric disorder
Regular use of any therapeutic or recreational psychoactive drug use during the last three months (with the exception of nicotine and alcohol) or other substance use disorder (including nicotine)
Abnormal body mass (as defined as not within 20% of normal body mass index).
Current past or anticipated exposure to radiation exceeding 20 mSv in the last year.
Metal implants or paramagnetic objects within the body which may interfere with the magnetic resonance imaging (MRI).
Claustrophobia or a history of panic attacks
Abnormal clinical laboratory findings including serum creatinine greater than 2.0 mg/dl, abnormal liver function tests, elevated serum bilirubin (more than 1.5 times upper limit of normal), or pre-trial electrocardiogram (EKG) results demonstrating clinical significant abnormality