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)
Improving clinical outcomes in treating heroin dependence: randomized, controlled trial of oral or implant naltrexone. [2009.10]
CONTEXT: Oral naltrexone hydrochloride effectively antagonizes heroin, but its utility is limited by patient noncompliance. Sustained-release preparations may overcome this limitation. OBJECTIVE: To compare the safety and efficacy of a single-treatment sustained-release naltrexone implant with daily oral naltrexone treatment... CONCLUSIONS: The naltrexone implant effectively reduced relapse to regular heroin use compared with oral naltrexone and was not associated with major adverse events. Clinical Trial Registration anzctr.org.au Identifier: ACTRN12606000308594.
A Randomized, Double-Blind, Placebo-Controlled Pilot Study of Naltrexone in Outpatients With Bipolar Disorder and Alcohol Dependence. [2009.08.10]
Background: Alcohol dependence is extremely common in patients with bipolar disorder and is associated with unfavorable outcomes including treatment nonadherence, violence, increased hospitalization, and decreased quality of life. While naltrexone is a standard treatment for alcohol dependence, no controlled trials have examined its use in patients with co-morbid bipolar disorder and alcohol dependence...
Targeted naltrexone for problem drinkers. [2009.08]
This study aimed to replicate and extend prior research showing that the targeted use of naltrexone is a useful strategy to reduce heavy drinking. We compared the effects of naltrexone with those of placebo in a sample of 163 individuals (58.3% male) whose goal was to reduce their drinking to safe limits...
Efficacy of oral naltrexone on pruritus in atopic eczema: a double-blind, placebo-controlled study. [2009.08]
AIM: The intent of our study was to determine the efficacy of oral naltrexone, an opioid antagonist, in the treatment of pruritus in patients with chronic eczema... CONCLUSION: Naltrexone is more effective than placebo in the treatment of pruritus in patient with eczema. Naltrexone might be considered as an adjunct treatment in the treatment of pruritus. However, further studies in this aspect are highly fostered.
Predicting the effect of naltrexone and acamprosate in alcohol-dependent patients using genetic indicators. [2009.07]
Acamprosate and naltrexone are effective medications in the treatment of alcoholism. However, effect sizes are modest... It is expected that more effective treatments can be offered when genetic information is used in patient-treatment-matching.
Clinical Trials Related to Vivitrol (Naltrexone)
Behavioral Naltrexone Therapy (BNT) for Promoting Adherence to Oral Naltrexone (BNT-oral) vs Extended Release Injectable Depot Naltrexone (Depot-BNT); a Randomized Trial. A Free Treatment for Opiate Abuse. [Recruiting]
In pilot study now proposed, we plan to randomly assign 60 opioid dependent patients to the
new model, Depot-BNT, or to BNT plus oral naltrexone for a 6-month trial. This will provide
initial clinical experience with the new Depot-BNT treatment model, while providing a
rigorous test of whether Depot-BNT produces superior treatment outcome, compared to our best
behavioral platform for oral naltrexone (BNT).
The following aims will be addressed:
Specific Aim #1: To test whether Depot-BNT increases retention in treatment and improves
drug use outcome (urine-confirmed abstinent weeks) compared to our established model of BNT
with oral naltrexone (BNT-Oral), and to explore whether Depot-BNT (vs BNT-Oral) improves key
secondary outcomes including dysphoria, HIV risk behavior, and social functioning.
Specific Aim #2: To explore predictors of outcome on Depot-BNT, and mechanisms of attrition,
in order to optimize Depot-BNT prior to further testing.
Extended-Release Naltrexone for Alcohol Dependence in Primary Care [Recruiting]
Naltrexone is an opioid antagonist with a high affinity for the mu opioid receptor. The
efficacy of extended-release naltrexone (Vivitrol) as a treatment for alcohol dependence has
been demonstrated in clinical trials, raising the prospect of integrating pharmacologic
treatment for alcohol dependence into general medical care settings. However, the
feasibility of implementing this FDA approved treatment in the front-line settings in which
it is most needed has not been demonstrated. This is an open-label pilot feasibility study
of implementing treatment with Vivitrol in primary care medical clinics in a safety net
hospital system affiliated with an urban academic center.
VIVITROL as a Treatment for Cocaine and Alcohol Dependence [Recruiting]
Efficacy and Safety of Vivitrol® After Enforced Abstinence [Recruiting]
Effectiveness of Naltrexone Versus Placebo to Reduce Craving for Alcohol With Evaluation of Genetic Variability. [Recruiting]
The purpose of this study is to determine whether naltrexone (an opiate blocking agent
approved for the treatment of alcohol dependence) is more effective in the reduction of
alcohol craving and drinking compared to placebo in individuals with particular genetic
predisposition.
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