Alcohol Craving Clinical Trial
Official title:
A Pharmacotherapy Study: A Dose Response Effect of Atomoxetine on Alcohol-elicited Craving and Sensitivity to the Acute Effects of Alcohol
This two-stage study will examine the effects of a 5 day course of atomoxetine (placebo, 40,
60 or 80 mg/day; Strattera) (a selective NE transporter (NET) inhibitor) on alcohol-elicited
craving and sensitivity to alcohol. The novelty of this study is that of atomoxetine and the
fact that it targets NET, neither of which has heretofore been examined in the context of
alcohol dependence. It is hopeful that this pilot study, of 86 total individuals, will
provide the PI with sufficient preliminary data to submit a subsequent R01 application to
study atomoxetine and the involvement of specific single nucleotide polymorphisms within the
NET gene on alcohol-related phenotypes in alcohol dependent and non-dependent populations.
The long-term objective of this research is to develop more efficacious treatment
interventions for alcohol abuse and dependence.
Hypothesis 1: It is hypothesized that subjects who receive 40, 60 or 80 mg/day of
atomoxetine for 5 days will demonstrate significantly less alcohol-elicited craving than
subjects who receive a placebo.
Hypothesis 2: It is hypothesized that subjects who receive 40, 60 or 80 mg/day of
atomoxetine for 5 days will be less sensitive to the acute effects of alcohol (subjective
intoxication) than subjects who receive a placebo.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science
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