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Vivitrol (Naltrexone) - Summary

 
 



BOX WARNING

Naltrexone has the capacity to cause hepatocellular injury when given in excessive doses.

Naltrexone is contraindicated in acute hepatitis or liver failure, and its use in patients with active liver disease must be carefully considered in light of its hepatotoxic effects.

The margin of separation between the apparently safe dose of naltrexone and the dose causing hepatic injury appears to be only five-fold or less. VIVITROL does not appear to be a hepatotoxin at the recommended doses.

Patients should be warned of the risk of hepatic injury and advised to seek medical attention if they experience symptoms of acute hepatitis. Use of VIVITROL should be discontinued in the event of symptoms and/or signs of acute hepatitis.

 

VIVITROL SUMMARY

VIVITROL® (naltrexone for extended-release injectable suspension) is supplied as a microsphere formulation of naltrexone for suspension, to be administered by intramuscular injection. Naltrexone is an opioid antagonist with little, if any, opioid agonist activity.

VIVITROL is indicated for the treatment of alcohol dependence in patients who are able to abstain from alcohol in an outpatient setting prior to initiation of treatment with VIVITROL.

Patients should not be actively drinking at the time of initial VIVITROL administration.

Treatment with VIVITROL should be part of a comprehensive management program that includes psychosocial support.


See all Vivitrol indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Vivitrol (Naltrexone)

Novel Nonopioid Approach Promising for Opioid Dependence
Source: Medscape Psychiatry & Mental Health Headlines [2014.04.16]
The combination of a muscle relaxant, an antihistamine, and an anticonvulsant may be a better way to detox opioid-dependent patients than a protocol that involves buprenorphine/naltrexone.
Medscape Medical News

more news >>

Published Studies Related to Vivitrol (Naltrexone)

Low-dose naltrexone for the treatment of fibromyalgia: Findings of a small, randomized, double-blind, placebo-controlled, counterbalanced, crossover trial assessing daily pain levels. [2013]
fatigue... CONCLUSION: The preliminary evidence continues to show that low-dose naltrexone

Evaluation of naltrexone for dissociative symptoms in borderline personality disorder. [2012.01]
Data from a pilot study suggest that naltrexone might reduce dissociative symptoms in patients with borderline personality disorder. However, the interpretation of these data is limited by the lack of a control group and by the nonblind nature of this study...

Does adding low doses of oral naltrexone to morphine alter the subsequent opioid requirements and side effects in trauma patients? [2012.01]
OBJECTIVE: The present study aims to assess the influence of ultra-low doses of opioid antagonists on the analgesic properties of opioids and their side effects... CONCLUSION: The combination of ultra-low-dose naltrexone and morphine in extremity trauma does not affect the opioid requirements; it, however, lowers the risk of nausea. Copyright (c) 2012 Elsevier Inc. All rights reserved.

Hepatic safety of injectable extended-release naltrexone in patients with chronic hepatitis C and HIV infection. [2012]
CONCLUSIONS: XR-NTX can be used safely in eligible patients with opioid

The combination very low-dose naltrexone-clonidine in the management of opioid withdrawal. [2012]
BACKGROUND: The management of withdrawal absorbs substantial clinical efforts in opioid dependence (OD)... CONCLUSIONS AND SCIENTIFIC SIGNIFICANCE: Preliminary results elucidate neurobiological mechanisms of OD and support the utility of controlled studies on a novel VLNTX + low-dose clonidine combination for the management of opioid withdrawal.

more studies >>

Clinical Trials Related to Vivitrol (Naltrexone)

VIVITROL as a Treatment for Cocaine and Alcohol Dependence [Recruiting]

Naltrexone for Heavy Drinking in Young Adults [Recruiting]
In this study, 132 heavy drinking young adults (aged 18-25) will be provided with brief counseling and either naltrexone, a medication that is FDA-approved for the treatment of alcohol dependence, or placebo over the course of 8 weeks. A novel strategy will be used for administering low-dose naltrexone, in which daily dosing will be combined with targeted dosing in anticipation of high-risk situations. The main hypotheses are that daily + targeted naltrexone will result in greater reductions in frequency of heavy and any drinking compared with daily + targeted placebo.

Improved Strategies for Outpatient Opioid Detoxification [Recruiting]
The investigators will randomize 100 opioid-dependent participants to one of two outpatient detoxification strategies: (1) a standard 7-day buprenorphine induction and gradual taper from 8 mg to 0 mg vs. (2) 7-day oral naltrexone induction; both groups will receive a single administration of a Vivitrol injection: at Day 8 for the naltrexone induction group and Day 15 for the buprenorphine group. The naltrexone arm is a modification of our current inpatient naltrexone induction procedure, consisting of a single day of buprenorphine followed by a washout day and 4 days of ascending oral naltrexone doses, prior to administering a dose of injectable naltrexone on Day 8. All participants will receive an intensive behavioral therapy for five weeks and will be followed for the subsequent 8 weeks to assess the longer-term outcome of the initial treatment. The primary outcome will be percentage of patients in each group successfully inducted onto Vivitrol. Key secondary outcomes will be 2-week abstinence at Weeks 4-5 (3rd and 4th weeks after Vivitrol injection), rates of completion of the 8-day detoxification, and percentage of patients in each group who return for additional Vivitrol injections in post-study follow-up. The main goal of this Stage 1a pilot study is to develop an improved outpatient opioid detoxification strategy, with particular relevance to newly diagnosed heroin addicts and prescription opioid abusers not seeking long-term agonist maintenance.

Specific Aim #1: To develop procedures for outpatient opioid detoxification which include naltrexone to facilitate detoxification.

Specific Aim #2: To compare injectable naltrexone induction rates between the naltrexone and buprenorphine groups following short-term outpatient opioid detoxification approach for initiating treatment for opioid dependence.

Low Dose Naltrexone-buprenorphine Transfer to Vivitrol Injection in Opioid Dependents [Recruiting]
The purpose of this study is to evaluate a very low dose naltrexone-buprenorphine treatment to transfer opioid dependent individuals to extended release naltrexone injection (Vivitrol). The hypothesis is that patients will complete the transfer to Vivitrol successfully, finding the treatment acceptable and showing minimal withdrawal discomfort.

Extended Release Naltrexone for Treating Amphetamine Dependence in Iceland [Not yet recruiting]
Until positive results were found with oral naltrexone, no medication has been effective against amphetamine dependence. The primary aim of this pilot study is to replicate the findings of the Swedish team that showed oral Naltrexone prevented relapse to amphetamine addiction and to extend their results by randomizing treatment-seeking amphetamine addicted patients to a 6 month course of VIVITROL (naltrexone for extended-release injectable suspension) or VIVITROL placebo. Patients in each group will receive drug counseling. VIVITROL is administered monthly and may be a better test of efficacy than tablets that must be taken daily.

more trials >>

Reports of Suspected Vivitrol (Naltrexone) Side Effects

Death (18)Injection Site Pain (8)Overdose (7)Injection Site Reaction (7)Depression (7)Nausea (6)Treatment Noncompliance (5)Injection Site Abscess (5)Insomnia (5)Confusional State (4)more >>


Page last updated: 2014-04-16

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