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Vivitrol (Naltrexone) - Summary

 
 



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.

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

Alcohol Dependence

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.

Opioid Dependence

VIVITROL is indicated for the prevention of relapse to opioid dependence, following opioid detoxification.


See all Vivitrol indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Vivitrol (Naltrexone)

Vivitrol Cuts Relapse Risk in Opioid Addicts
Source: MedicineNet oxycodone Specialty [2016.03.31]
Title: Vivitrol Cuts Relapse Risk in Opioid Addicts
Category: Health News
Created: 3/31/2016 12:00:00 AM
Last Editorial Review: 3/31/2016 12:00:00 AM

more news >>

Published Studies Related to Vivitrol (Naltrexone)

Naltrexone for impulse control disorders in Parkinson disease: a placebo-controlled study. [2014]
of ICDs in PD... CONCLUSIONS: Naltrexone treatment was not efficacious for the treatment of ICDs

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

Effectiveness of naltrexone in the prevention of delayed respiratory arrest in opioid-naive methadone-intoxicated patients. [2013]
Acute methadone toxicity is a major public health concern in Iran... Further studies are warranted before the generalization of this approach to other patient populations.

Naltrexone with or without guanfacine for preventing relapse to opiate addiction in St.-Petersburg, Russia. [2013]
induced craving and have reduced opiate relapse in small clinical trials... CONCLUSIONS: Adding guanfacine to naltrexone did not improve treatment retention

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

more studies >>

Clinical Trials Related to Vivitrol (Naltrexone)

ALK21-014: Efficacy and Safety of Medisorb� Naltrexone (VIVITROL�) After Enforced Abstinence [Completed]
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. This Phase 3B trial was designed to evaluate the efficacy and safety of VIVITROL versus placebo. Injections were administered to patients in whom abstinence was enforced by a period of inpatient hospitalization of 7 to 21 days.

The Separate and Combined Effects of Vivitrol and Opiate Abstinence Reinforcement in the Treatment of Opioid Dependence [Recruiting]

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.

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

A Study of VIVITROL in the Prevention of Re-arrest and Re-incarceration [Completed]
This phase 4 study will evaluate the feasibility of initiating subjects on VIVITROL in prison and continuing VIVITROL upon release into the community.

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: 2016-03-31

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