Effectiveness of Naltrexone Versus Placebo to Reduce Craving for Alcohol With Evaluation of Genetic Variability.

Phase 4 Completed 83 enrolled Medical University of South Carolina

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to determine whether naltrexone (an opiate blocking agent approved for the treatment of alcohol dependence) is more effective in the reduction of alcohol craving and drinking compared to placebo in individuals with particular genetic predisposition.

Timeline

Start: 2006-04
Primary completion: 2010-01
Completion: 2010-01

Outcome

Missed primary endpoint

registry p = 0.51; Mean Difference (Final Values) 0.92 (95% CI -1.85 to 3.69); ANOVA NCT00366626 ↗

registry p = 0.28; Mean Difference (Final Values) 1.46 (95% CI -1.22 to 4.11); ANOVA NCT00366626 ↗

Publications

Anton RF, Voronin KK, Randall PK, Myrick H, Tiffany A. Naltrexone modification of drinking effects in a subacute treatment and bar-lab paradigm: influence of OPRM1 and dopamine transporter (SLC6A3) genes. Alcohol Clin Exp Res. 2012 Nov;36(11):2000-7. doi: 10.1111/j.1530-0277.2012.01807.x. Epub 2012 May 2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Naltrexone	Small molecule	50 mg	—