Efficacy and Tolerability of Long-Acting Injectable Naltrexone for Alcohol Dependence
JAMAPublished 6 April 2005
James C. Garbutt, Henry R. Kranzler, Stephanie S. O’Malley, David R. Gastfriend, Helen M. Pettinati, Bernard L. Silverman
Citations612
SJR quartileQ1
SJR score5.35
SNIP10.71
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Abstract
Long-acting naltrexone was well tolerated and resulted in reductions in heavy drinking among treatment-seeking alcohol-dependent patients during 6 months of therapy. These data indicate that long-acting naltrexone can be of benefit in the treatment of alcohol dependence.
Keywords
Medicine
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