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CompletedNCT01638364Updated Jul 28, 2015

Dopamine Release in the Human Brain Following Alcohol Administration

A Phase 1 interventional study of alcoholic beverage and non-alcoholic beverage in Heavy Drinking, sponsored by Centre for Addiction and Mental Health. Completed at 1 site in Canada. Open to participants aged 21 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-07-28.

Sponsored by Centre for Addiction and Mental Health · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
8
Allocation
Randomized
Ages
21 Years to 45 Years
Sex
All
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Study 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).

Read the detailed 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.

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Conditions studied

  • Heavy Drinking
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In context

Lead sponsor

Centre for Addiction and Mental Health is the lead sponsor of 327 studies on the registry; 51 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
21 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
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Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
8 participants (actual)

Study arms

  • Active comparator
    alcoholic beverage

    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

  • Placebo comparator
    non-alcoholic beverage

    Orange juice and tonic water.

    Drug: non-alcoholic beverage

Interventions

  • Drugalcoholic beverage

    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%

  • Drugnon-alcoholic beverage

    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.

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What researchers measure

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.

    Time frame: 2 weeks

Secondary outcomes

  1. Subjective effects of alcohol

    During the PET scans, the subjective effects ( Alcohol Urges Scale, Biphasic Alcohol Effects Scale)of alcohol will be assessed at various time points throughout beverage consumption and PET scan.

    Time frame: 2 weeks

  2. Objective effects of alcohol

    During the PET scans, the objective effects of alcohol (blood pressure, heart rate, blood alcohol content, blood cortisol levels) will be assessed at various time points throughout the drink consumption and PET scan.

    Time frame: 2 weeks

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Study locations

1 site
  • Centre for Addiction and Mental Health
    Toronto, Ontario M5T 1R8, Canada
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References and documents

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 28, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01638364
Lead sponsor
Centre for Addiction and Mental Health
Responsible party
Bernard Le Foll (Principal Investigator; MD, PhD, CCFP, Centre for Addiction and Mental Health) — Principal investigator
First posted
Jul 11, 2012
Start date
Jan 2013
Primary completion
Jun 2015
Completion
Jun 2015
Last update
Jul 28, 2015

Study contacts

Bernard Le Foll, MD, PhD
principal investigator · Centre for Addiction and Mental Health

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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