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Fda naltrexone implant

Posted Apr 21, 2016 by Admin

Drug Alcohol Rev. 2014;33(2 115-128).The authors stated that the evidence on safety and effectiveness of naltrexone implants is limited in quantity and quality, and the evidence has little clinical utility in settings where effective treatments for opioid dependence are used.  However, since then, some randomized controlled clinical trials of naltrexone implants have been published examining the effectiveness of the naltrexone implants for narcotic addictions.  Limitations include the fact that these studies were not U.S.

Moreover, they stated that further research is needed. Larney et al (2014) systematically reviewed the literature to evaluate the safety and effectiveness of naltrexone implants for treating opioid dependence.  Studies were eligible if they compared naltrexone implants with another intervention or placebo.Of the 44 subjects, 29 (65.9 ) interviewed reported that following treatment they ceased using and maintained abstinence from amphetamines for at least 1 month.  Of these patients, 14 (48.3 ) were reportedly still abstinent at 6 months.

 Rates of abstinence were found to be 2.27 times higher (95 confidence interval (CI 1.38 to 3.74) in patients when blood naltrexone levels were above 2 ng/ml, with rates as high as 100 and 90.9 for greater than or equal to 5 and greater than or. No difference in opioid use was observed between naltrexone implants and methadone maintenance (standardized mean difference: -0.33; 95 CI: -0.93 to 0.26; k 1 however, this finding was based on low-quality evidence from 1 study. 

Arch Gen Psychiatry. 2012;69(9 973-981. Tiihonen J, Krupitsky E, Verbitskaya E, et al. Naltrexone implant for the treatment of polydrug dependence: A randomized controlled trial. Am J Psychiatry. 2012;169(5 531-536. Kelty E, Thomson K, Carlstein S, et al.They concluded that better designed research is needed to establish the safety and effectiveness of naltrexone implants; until such time, their use should be limited to clinical trials. Information in the brackets below has been added for clarification purposes. 

Crystallization naltrexone

Addiction. 2012,. Gibson AE, Degenhardt LJ, Hall WD. Opioid overdose deaths can occur in patients with naltrexone implants. Med J. Australia.2007;. Gibson AE, Degenhardt LJ, Mortality related to pharmacotherapies for opioid dependence: A comparative analysis of coronial records.Further research is needed to establish the risk of mortality during and after treatment with naltrexone implants and other treatment approaches. Kelly et al (2013) examined self-reported abstinence from amphetamines following treatment with a sustained release naltrexone preparation in patients with self and clinically identified.

Drug Alcohol Rev. 2007;. Olivier P. Fatal opiate overdose following regimen changes in naltrexone treatment. Addiction. 2005;100:560563. Ngo HT, Tait RJ, Hulse GK. Comparing drug-related hospital morbidity following heroin dependence treatment with methadone maintenance or naltrexone implantation.Number: 0878 Policy Aetna considers naltrexone implants experimental and investigational for treatment of alcohol addiction, amphetamine use, narcotic addiction, and all other indications because of insufficient evidence in the peer-reviewed published medical literature of their safety and effectiveness.

The authors concluded that although this study has several limitations, the findings provided preliminary data in support of the use of implant naltrexone for the treatment of problematic amphetamine use and suggested that naltrexone levels above 2 ng/ml should be targeted for use in patients.  Data from randomized studies were combined using meta-analysis.  Data from non-randomized studies were presented narratively.  A total of 5 randomized trials (n 576) and 4 non-randomized studies (n 8,358) were eligible for review.

Review concluded that evidence is currently at an early stage and as such, naltrexone implants remain an experimental product and should only be used within a research setting.  Until the relevant data are available and validated, the efficacy of the treatment, alone or in comparison.Some concerns with the methodology of this study have been raised including the comparison used; it was suggested that comparison with currently accepted modes of treatment such as opioid substitution treatment would be more appropriate (Hickman et al, 2012).

There are some published reports of deaths attributable to naltrexone implants (Gibson et al, 2007a; Gibson et al, 2007b; Olivier, 2005) and other reports claiming significantly reduced mortality (Ngo et al., 2008). NHMRC s position on naltrexone implants is that further research on adverse effects is required before a statement on safety can be confidently made. Specifically regarding the use of the naltrexone implant for alcoholism, a systematic evidence review concluded that larger longitudinal studies of the.

Background Naltrexone is a drug used in the management of alcohol and opioid dependence.  When taken, naltrexone attaches to the opiate receptors in the brain and blocks them, preventing the euphoric effect from the opiate.A total of 44 patients with problematic amphetamine use, who were treated with a naltrexone implant, completed an interview evaluating self-reported reduction in amphetamine use following treatment.  Additional data were collected from the patients' clinical treatment files.