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Report for Clinical Trial NCT01408589

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

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.

NCT01408589 Alcohol Craving Mood Changes

1 Interventions

Name: Atomoxetine, Strattera

Description: Atomoxetine at 0, 40, 60, 80 mg/day was given for 5 days, all subjects took two capsules per day for 5 days; all active dose groups received 40 mg/day for first 3 days and where then dose escalated to dosage group assigned.
Type: Drug
Group Labels: 4

Atomoxetine 40 mg Atomoxetine 60 mg Atomoxetine 80 mg Sugar Pill


Primary Outcomes

Description: Alcohol craving and sensitivity were measured with the AUQ, ARS, POMS, BAES and SHAS

Measure: Alcohol Craving

Time: Day 5 of medication

Secondary Outcomes

Description: To determine whether two functional SNPs within the COMT and DBH genes moderate the effects of EtOH and or atomoxetine. COMT Val158Met (G/A), Val > Met 2-4x plasma activity DBH -1021 C/T, C/C has 3x more plasma activity NET gene variants were also examined

Measure: Genetic moderation

Time: day 5 of medication

Purpose: Basic Science

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 V158M

COMT Val158Met (G/A), Val > Met 2-4x plasma activity DBH -1021 C/T, C/C has 3x more plasma activity NET gene variants were also examined. --- Val158Met ---



HPO Nodes