Dopamine Release in the Human Brain Following Alcohol Administration

NCT01638364 | Completed Phase 1

• 1 other identifier: 041/2012
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Heavy Drinking

Outcome Measures

Primary Outcomes (1)

• Change in PHNO Binding Potential

  Following the injection of the positron-emitting radiotracer \[11C\]-(+)-PHNO, binding of this radiotracer to dopamine receptors (DR) D2/3 will be measured using the PET scanner. As dopamine also binds to DR D2/3, either an increase or decrease in dopamine levels will either decrease or increase PHNO occupancy respectively. \[11C\]-(+)-PHNO binding potential will be measured on two different conditions (alcoholic beverage vs non-alcoholic beverage) on two separate days.

  2 weeks

Secondary Outcomes (2)

• Subjective effects of alcohol

  2 weeks

• Objective effects of alcohol

  2 weeks

Study Arms (2)

alcoholic beverage

ACTIVE COMPARATOR

95% USP alcohol given at a dose of 1.5 g/l of body water mixed with orange juice and tonic water.

Drug: alcoholic beverage

non-alcoholic beverage

PLACEBO COMPARATOR

Orange juice and tonic water.

Drug: non-alcoholic beverage

Interventions

alcoholic beverage DRUG

An appropriate amount of 95% USP ethyl alcohol will be mixed in orange juice and tonic water to obtain a drink equivalent to 3-5 standard drinks. The beverage will be consumed over a period of 15 minutes.

Also known as: Ethyl alcohol 95%

alcoholic beverage

non-alcoholic beverage DRUG

This beverage will be a mixture of orange juice and tonic water. The beverage will be consumed over a period of 15 minutes.

Also known as: Tropicana orange juice and Schweppes tonic water.

non-alcoholic beverage

Eligibility Criteria

• Age: 21 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre for Addiction and Mental Health: lead

Study Sites (1)

Centre for Addiction and Mental Health

Toronto, Ontario, M5T 1R8, Canada

Location

Related Links

• Link Text: Information about research at the Centre for Addiction and Mental Health, Canada's largest mental health and addiction teaching

MeSH Terms

Interventions

Alcoholic Beverages; Ethanol

Intervention Hierarchy (Ancestors)

Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Alcohols; Organic Chemicals

Study Officials

• Bernard Le Foll, MD, PhD

  Centre for Addiction and Mental Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator; MD, PhD, CCFP

Study Record Dates

• First Submitted: June 28, 2012
• First Posted: July 11, 2012
• Study Start: January 1, 2013
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: July 28, 2015

Record last verified: 2015-07

Locations

CA (1)