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      Naltrexone long-acting formulation in the treatment of alcohol dependence

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          Abstract

          While oral naltrexone has a demonstrated ability to decrease alcohol reinforcement, it also has pharmacotherapeutic limitations, such as a small treatment effect size, adverse events, and plasma level fluctuations. The pharmacokinetic profile of naltrexone could be enhanced by intramuscular administration, which would sustain its release over several weeks and keep plasma levels relatively constant, ie, low enough to minimize side effects but high enough to reduce drinking. Vivitrex ®/Vivitrol ® and Naltrel ® are injectable naltrexone depot formulations that have been tested as possible medications for treating alcohol dependence. Their adverse-event profiles appear to be less severe than that of oral naltrexone. Vivitrex ®/Vivitrol ® has demonstrated efficacy at decreasing heavy drinking among alcohol-dependent males. Naltrel ® helped to promote abstinence and decrease the incidence of relapse in two samples of alcohol-dependent subjects. The data on a third formulation, Depotrex ®, are still limited. All three formulations require further study of their efficacy.

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          Most cited references 40

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          Naltrexone in the treatment of alcohol dependence.

          Seventy male alcohol-dependent patients participated in a 12-week, double-blind, placebo-controlled trial of naltrexone hydrochloride (50 mg/d) as an adjunct to treatment following alcohol detoxification. Subjects taking naltrexone reported significantly less alcohol craving and days in which any alcohol was consumed. During the 12-week study, only 23% of the naltrexone-treated subjects met the criteria for a relapse, whereas 54.3% of the placebo-treated subjects relapsed. The primary effect of naltrexone was seen in patients who drank any alcohol while attending outpatient treatment. Nineteen (95%) of the 20 placebo-treated patients relapsed after they sampled alcohol, while only eight (50%) of 16 naltrexone-treated patients exposed to alcohol met relapse criteria. Naltrexone was not associated with mood changes or other psychiatric symptoms. Significant side effects (nausea) occurred in two naltrexone-treated subjects, and one naltrexone-treated subject complained of increased pain from arthritis. These results suggest that naltrexone may be a safe and effective adjunct to treatment in alcohol-dependent subjects, particularly in preventing alcohol relapse.
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            A psychomotor stimulant theory of addiction.

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              Efficacy and tolerability of long-acting injectable naltrexone for alcohol dependence: a randomized controlled trial.

              Alcohol dependence is a common disorder associated with significant morbidity and mortality. Naltrexone, an opioid antagonist, has been shown to be effective for treatment of alcohol dependence. However, adherence to daily oral pharmacotherapy can be problematic, and clinical acceptance and utility of oral naltrexone have been limited. To determine efficacy and tolerability of a long-acting intramuscular formulation of naltrexone for treatment of alcohol-dependent patients. A 6-month, randomized, double-blind, placebo-controlled trial conducted between February 2002 and September 2003 at 24 US public hospitals, private and Veterans Administration clinics, and tertiary care medical centers. Of the 899 individuals screened, 627 who were diagnosed as being actively drinking alcohol-dependent adults were randomized to receive treatment and 624 received at least 1 injection. An intramuscular injection of 380 mg of long-acting naltrexone (n = 205) or 190 mg of long-acting naltrexone (n = 210) or a matching volume of placebo (n = 209) each administered monthly and combined with 12 sessions of low-intensity psychosocial intervention. The event rate of heavy drinking days in the intent-to-treat population. Compared with placebo, 380 mg of long-acting naltrexone resulted in a 25% decrease in the event rate of heavy drinking days (P = .02) [corrected] and 190 mg of naltrexone resulted in a 17% decrease (P = .07). Sex and pretreatment abstinence each showed significant interaction with the medication group on treatment outcome, with men and those with lead-in abstinence both exhibiting greater treatment effects. Discontinuation due to adverse events occurred in 14.1% in the 380-mg and 6.7% in the 190-mg group and 6.7% in the placebo group. Overall, rate and time to treatment discontinuation were similar among treatment groups. 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.
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                Author and article information

                Journal
                Ther Clin Risk Manag
                Therapeutics and Clinical Risk Management
                Therapeutics and Clinical Risk Management
                Dove Medical Press
                1176-6336
                1178-203X
                October 2007
                October 2007
                : 3
                : 5
                : 741-749
                Affiliations
                Department of Psychiatry and Neurobehavioral Sciences, University of Virginia Charlottesville, VA, USA
                Author notes
                Correspondence: Bankole A Johnson Alumni Professor and Chairman, Department of Psychiatry and Neurobehavioral Sciences, University of Virginia, PO Box 800623, Charlottesville, VA 22908-0623, USA Tel +1 434 924 5457 Fax +1 434 244 7565 Email bankolejohnson@ 123456virginia.edu
                Article
                2376083
                18472999
                © 2007 Dove Medical Press Limited. All rights reserved
                Categories
                Review

                Medicine

                vivitrex®, naltrel®, depotrex®, naltrexone, alcohol dependence, depot, vivitrol®

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