NCT01638364|CompletedPhase 1
Dopamine Release in the Human Brain Following Alcohol Administration
Imaging Alcohol Induced Dopamine Release in the Human Brain: a PET/[11C](+)PHNO Study
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Imaging Alcohol Induced Dopamine Release in the Human Brain: a PET/[11C](+)PHNO Study
Sponsor study identifier
interventional
8
1 country
1
Study Start
January 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2015
Actual (reported)Study Completion
June 2015
Actual (reported)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).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2015
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 28, 2012
Actual (reported)July 11, 2012
Actual (reported)January 2013
Date type not reportedThis date has not been verified as actual or estimated.
June 2015
Actual (reported)June 2015
Actual (reported)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
Subjective effects of alcohol
2 weeks
Objective effects of alcohol
2 weeks
95% USP alcohol given at a dose of 1.5 g/l of body water mixed with orange juice and tonic water.
Orange juice and tonic water.
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.
This beverage will be a mixture of orange juice and tonic water. The beverage will be consumed over a period of 15 minutes.
Centre for Addiction and Mental Health
Toronto, Ontario, M5T 1R8, Canada
Bernard Le Foll, MD, PhD
Centre for Addiction and Mental Health
8 participants (actual enrollment reported by the registry).
First Submitted
June 28, 2012
First Posted
July 11, 2012
Study Start
January 2013
Date type not reportedThis date has not been verified as actual or estimated.
Brief Religious Alcohol Intervention
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
June 2015
Actual (reported)Study Completion
June 2015
Actual (reported)Last Updated
July 28, 2015
Record last verified: 2015-07
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Source: ClinicalTrials.gov.
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