Vivitrol

Background : U.S. is experiencing a surging trend of methamphetamine use among individuals who use opioids. More research is needed to characterize this emerging "twin epidemic." Objectives: The study aims to identify social and behavioral characteristics associated with methamphetamine use among individuals with opioid use disorder (OUD) in the Dayton, Ohio, area, an epicenter of the opioid crisis and an emerging frontier of methamphetamine epidemic. Methods: 357 adult individuals with current OUD were recruited using targeted and respondent-driven sampling...

BACKGROUND: Opioid use disorder (OUD) has become an increasingly consequential public health concern, especially in the United States where 47,600 opioid overdose deaths occurred in 2017 (Scholl, Seth, Kariisa, Wilson, & Baldwin, 2019). Medications for OUD (MOUD) are effective for decreasing opioid-related morbidity and mortality, including within the criminal justice system (Hedrich et al., 2012; Medications for Opioid Use Disorder Save Lives, 2019; Moore et al., 2019).While a stronger evidence base exists for agonist MOUD than for antagonist MOUD, a national study of drug courts found that half prohibited agonist MOUD (Matusow et al...

BACKGROUND: Opioid use disorder (OUD) has become an increasingly grave public health concern, especially in the United States where approximately 80% of the global opioid supply is consumed. Despite greater awareness of the present overdose crisis, potentially life-saving OUD pharmacotherapy (medications for opioid use disorder or MOUD) utilization remains low. This study examines the extent of provider-directed marketing (detailing) for MOUD drugs and identifies any associations between a provider's receipt of detailing and their prescribing of MOUD drugs to Medicare Part D beneficiaries...

INTRODUCTION: Amfetamine and methamfetamine abuse remains a prevalent health problem, increasing the burden on healthcare. Naltrexone, a µ-opioid receptor antagonist, has been suggested as a promising treatment for amfetamine and methamfetamine use disorder. OBJECTIVE: To review the current evidence for the efficacy and safety of naltrexone as a pharmacological treatment for amfetamine and methamfetamine use disorder. The primary outcome was defined as abstinence or reduction of use...

Heroin is a growing national crisis in America. There is an increasing frequency of heroin overdoses. All of the currently used therapeutic approaches to treatment of heroin abuse and other opioid drugs of abuse focus on antagonizing a brain receptor (particularly µ-opiate receptors). However, it has been known that the therapeutic use of certain µ-opiate receptor antagonist may actually increase heroin overdose. Once overdosed, heroin addicts may continue to get overdosed again and again until fatal. Here we report our design and validation of a novel therapeutic strategy targeting heroin activation based on our analysis of the chemical transformation and functional change of heroin in the body...

Former inmates addicted to opioids too often land back in jail. A new program hopes to change that dynamic. It's based on the preached-more-than-practiced notion that people with opioid addiction need help, not punishment. Vivitrol injections are given to participants every 28 days for a year to help them stay clean.

The risk of severe precipitated opioid withdrawal (POW) is amplified when precipitated by a long-acting opioid antagonist. IM extended release naltrexone (XRNTX;Vivitrol®) is an FDA approved therapy to prevent relapse of opioid and alcohol abuse. Two cases of precipitated opioid withdrawal from XRNTX are presented that illustrate different patient reactions to POW. A 56-year-old woman developed a hypertensive emergency and required continuous intravenous vasodilator, clonidine, and intensive care monitoring after re-initiation of XRNTX following opioid relapse...

AIM: To evaluate the efficacy of treatment of patients at risk of deprivation of parental rights due to alcohol dependence under the 'Point of Soberness' program including psychotherapy and intramuscular injections of extended-release naltrexone (vivitrol). MATERIAL AND METHODS: Results of therapy of 45 patients, 39 women and 6 men, are presented. Out of 45 patients, 42 (93.3%) received a full course of injections of prolonged naltrexone (6 or more) as part of a comprehensive outpatient rehabilitation program...

INTRODUCTION: An extended-release injectable naltrexone suspension (Vivitrol® ) was approved in USA in 2010 for the prevention of relapse to opioid dependence. Concerns, raised at the time of approval, about rebound overdose risk following the last dose, have not been adequately studied. We sought to determine the time period of concern for fatal overdose associated with Vivitrol. METHODS: We performed a retrospective case review of Vivitrol spontaneous reports (October 2010-March 2016) in the US Food and Drug Administration Adverse Event Reporting System via the Freedom of Information Act...

BACKGROUND AND AIMS: Extended-release naltrexone (XR-NTX), a μ-opioid receptor antagonist for prevention of relapse to opioid dependence, has demonstrated efficacy compared with placebo and comparative effectiveness with buprenorphine-naloxone. We report outcomes for XR-NTX in Vivitrol's Cost and Treatment Outcomes Registry. DESIGN: Observational, open-label, single-arm, multi-center registry assessing baseline characteristics and clinical and health-related quality-of-life outcomes associated with XR-NTX treatment in clinical practice...

AIMS: To review systematically the published literature on extended-release naltrexone (XR-NTX, Vivitrol® ), marketed as a once-per-month injection product to treat opioid use disorder. We addressed the following questions: (1) how successful is induction on XR-NTX; (2) what are adherence rates to XR-NTX; and (3) does XR-NTX decrease opioid use? Factors associated with these outcomes as well as overdose rates were examined. METHODS: We searched PubMed and used Google Scholar for forward citation searches of peer-reviewed papers from January 2006 to June 2017...

BACKGROUND: Extended-release naltrexone (XR-NTX), an opioid antagonist, and sublingual buprenorphine-naloxone (BUP-NX), a partial opioid agonist, are pharmacologically and conceptually distinct interventions to prevent opioid relapse. We aimed to estimate the difference in opioid relapse-free survival between XR-NTX and BUP-NX. METHODS: We initiated this 24 week, open-label, randomised controlled, comparative effectiveness trial at eight US community-based inpatient services and followed up participants as outpatients...

Establishment of in vitro-in vivo correlations (IVIVCs) for parenteral polymeric microspheres has been very challenging, due to their complex multiphase release characteristics (which is affected by the nature of the drug) as well as the lack of compendial in vitro release testing methods. Previously, a Level A correlation has been established and validated for polymeric microspheres containing risperidone (a practically water insoluble small molecule drug). The objectives of the present study were: 1) to investigate whether a Level A IVIVC can be established for polymeric microspheres containing another small molecule drug with different solubility profiles compared to risperidone; and 2) to determine whether release characteristic differences (bi-phasic vs tri-phasic) between microspheres can affect the development and predictability of IVIVCs...

BACKGROUND AND AIMS: Criminal justice-involved individuals are highly susceptible to opioid relapse and overdose-related deaths. In a recent randomized trial, we demonstrated the effectiveness of extended-release naltrexone (XR-NTX; Vivitrol® ) in preventing opioid relapse among criminal justice-involved US adults with a history of opioid use disorder. The cost of XR-NTX may be a significant barrier to adoption. Thus, it is important to account for improved quality of life and downstream cost-offsets...

The objective of the present study was to develop a discriminatory and reproducible accelerated release testing method for naltrexone loaded parenteral polymeric microspheres. The commercially available naltrexone microsphere product (Vivitrol(®)) was used as the testing formulation in the in vitro release method development, and both sample-and-separate and USP apparatus 4 methods were investigated. Following an in vitro drug stability study, frequent media replacement and addition of anti-oxidant in the release medium were used to prevent degradation of naltrexone during release testing at "real-time" (37°C) and "accelerated" (45°C), respectively...

OBJECTIVES: This 2-stage open-label pilot study evaluated the safety and potential efficacy of naltrexone + bupropion as a pharmacotherapy for methamphetamine (MA) use disorder. METHODS: The study was conducted in 2 stages of recruitment across 3 sites; 20 participants were enrolled in stage 1 and 29 participants were enrolled in stage 2. Eight weeks of open-label pharmacotherapy with a combination of extended-release injectable naltrexone (XR-NTX; Vivitrol) plus extended-release oral bupropion (BRP; Wellbutrin XL) were provided with a smartphone-assisted medication adherence platform...

BACKGROUND: Despite the growing prevalence of opioid use among offenders, pharmacotherapy remains an underused treatment approach in correctional settings. The aim of this 4-year trial is to assess the clinical utility, effectiveness, and cost implications of extended-release naltrexone (XR-NTX, Vivitrol®; Alkermes Inc.) alone and in conjunction with patient navigation for jail inmates with opioid use disorder (OUD). METHODS: Opioid-dependent inmates will be randomly assigned to one of three treatment conditions before being released to the community to include: 1) XR-NTX only; 2) XR-NTX plus patient navigation (PN), and 3) enhanced treatment-as-usual (ETAU) with drug education and a community treatment referral...

BACKGROUND: Extended-release naltrexone, a sustained-release monthly injectable formulation of the full mu-opioid receptor antagonist, is effective for the prevention of relapse to opioid dependence. Data supporting its effectiveness in U.S. criminal justice populations are limited. METHODS: In this five-site, open-label, randomized trial, we compared a 24-week course of extended-release naltrexone (Vivitrol) with usual treatment, consisting of brief counseling and referrals for community treatment programs, for the prevention of opioid relapse among adult criminal justice offenders (i...

AIMS: To examine the safety and effectiveness of buprenorphine + naloxone sublingual tablets (BUP, as Suboxone(®) ) provided after administration of extended-release injectable naltrexone (XR-NTX, as Vivitrol(®) ) to reduce cocaine use in participants who met DSM-IV criteria for cocaine dependence and past or current opioid dependence or abuse. METHODS: This multi-centered, double-blind, placebo-controlled study, conducted under the auspices of the National Drug Abuse Treatment Clinical Trials Network, randomly assigned 302 participants at sites in California, Oregon, Washington, Colorado, Texas, Georgia, Ohio, New York and Washington DC, USA to one of three conditions provided with XR-NTX: 4 mg/day BUP (BUP4, n = 100), 16 mg/day BUP (BUP16, n = 100, or no buprenorphine (placebo; PLB, n = 102)...

This was a Phase 4, pilot, open-label feasibility study of extended-release injectable naltrexone (XR-NTX) administered to pre-release prisoners having a history of pre-incarceration opioid disorder. We evaluated the relationship between XR-NTX adherence and criminal recidivism (re-arrest and re-incarceration) and opioid and cocaine use. Twenty-seven pre-release male and female prisoners who had opioid disorders during the year prior to index incarceration were recruited and received one XR-NTX injection once each month for 7 months (1 injection pre-release from prison and 6 injections in the community) and of those 27, 10 (37%) were retained in treatment at 7-months post release...