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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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          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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              Biodegradation and biocompatibility of PLA and PLGA microspheres.

              A fundamental understanding of the in vivo biodegradation phenomenon as well as an appreciation of cellular and tissue responses which determine the biocompatibility of biodegradable PLA and PLGA microspheres are important components in the design and development of biodegradable microspheres containing bioactive agents for therapeutic application. This chapter is a critical review of biodegradation, biocompatibility and tissue/material interactions, and selected examples of PLA and PLGA microsphere controlled release systems. Emphasis is placed on polymer and microsphere characteristics which modulate the degradation behaviour and the foreign body reaction to the microspheres. Selected examples presented in the chapter include microspheres incorporating bone morphogenetic protein (BMP) and leuprorelin acetate as well as applications or interactions with the eye, central nervous system, and lymphoid tissue and their relevance to vaccine development. A subsection on nanoparticles and nanospheres is also included. The chapter emphasizes biodegradation and biocompatibility; bioactive agent release characteristics of various systems have not been included except where significant biodegradation and biocompatibility information have been provided.
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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
                e8d3c5a1-37ac-4b47-8495-0c6b1508f9fb
                © 2007 Dove Medical Press Limited. All rights reserved
                History
                Categories
                Review

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

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