Alcohol Sensitivity Clinical Trial
Official title:
A Gene by Medication Interaction to the Acute Effects of Alcohol
Alcohol dependence, or "alcoholism", affects approximately 14 million Americans. Currently,
only three pharmacotherapies (disulfiram, naltrexone, and acamprosate) have been approved
for the treatment of alcohol dependence and these medications are, at best, moderately
successful. Thus, there is a great need for the examination of other biological systems,
which contribute/influence the drug reward/addiction pathways within the brain, such that
the discovery of new targets and new pharmacotherapies will be possible. Other biological
systems in addition to dopamine, such as serotonin, and norepinephrine (NE) are thought to
be important in several aspects of addiction, including reward, craving and depression.
This study will examine the effects of a 5 day course of atomoxetine (a selective NE
transporter (NET) inhibitor) (80 mg/day; Strattera or placebo) 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 study, of 64 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.
Design:
NET genotype groups for rs11648486 SNP (CC 61%; CT 33%; TT 4%) (e.g., C/C and C/T) will be
compared to one another in a 2 (NET Genotype: C/C vs. C/T & T/T) x 2 (Medication:
atomoxetine 80 mg/day (~ vs. placebo) x 3 (Drink: Drink 1, 2, and 3) mixed factorial
repeated measures design using PROC MIXED in SAS by calculating difference scores. Of
interest are the possible interactions of the NET SNPs and atomoxetine on cue-elicited
craving and the rewarding effects of alcohol across trials.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01845220 -
Prevention of Alcohol Intolerance
|
Phase 2 |