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.
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NEWS HIGHLIGHTS
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.
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.
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 >>
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