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R S Wightman, L S Nelson, J D Lee, L M Fox, S W Smith
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...
March 21, 2018: American Journal of Emergency Medicine
T V Agibalova, I I Akhmetzyanov, R F Khaeva, G L Udachina, K N Poplevchenkov, A V Orlova, O V Nedobylskiy
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...
2018: Zhurnal Nevrologii i Psikhiatrii Imeni S.S. Korsakova
Roxanne Saucier, Daniel Wolfe, Nabarun Dasgupta
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...
March 20, 2018: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
Andrew J Saxon, Sarah C Akerman, Chih-Chin Liu, Maria A Sullivan, Bernard L Silverman, Frank J Vocci
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...
March 1, 2018: Addiction
Brantley P Jarvis, August F Holtyn, Shrinidhi Subramaniam, D Andrew Tompkins, Emmanuel A Oga, George E Bigelow, Kenneth Silverman
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...
February 3, 2018: Addiction
Joshua D Lee, Edward V Nunes, Patricia Novo, Ken Bachrach, Genie L Bailey, Snehal Bhatt, Sarah Farkas, Marc Fishman, Phoebe Gauthier, Candace C Hodgkins, Jacquie King, Robert Lindblad, David Liu, Abigail G Matthews, Jeanine May, K Michelle Peavy, Stephen Ross, Dagmar Salazar, Paul Schkolnik, Dikla Shmueli-Blumberg, Don Stablein, Geetha Subramaniam, John Rotrosen
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...
January 27, 2018: Lancet
Janki V Andhariya, Jie Shen, Stephanie Choi, Yan Wang, Yuan Zou, Diane J Burgess
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...
June 10, 2017: Journal of Controlled Release: Official Journal of the Controlled Release Society
Sean M Murphy, Daniel Polsky, Joshua D Lee, Peter D Friedmann, Timothy W Kinlock, Edward V Nunes, Richard J Bonnie, Michael Gordon, Donna T Chen, Tamara Y Boney, Charles P O'Brien
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...
August 2017: Addiction
Janki V Andhariya, Stephanie Choi, Yan Wang, Yuan Zou, Diane J Burgess, Jie Shen
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...
March 30, 2017: International Journal of Pharmaceutics
Larissa J Mooney, Maureen P Hillhouse, Christie Thomas, Alfonso Ang, Gaurav Sharma, Garth Terry, Linda Chang, Robrina Walker, Madhukar Trivedi, David Croteau, Steven Sparenborg, Walter Ling
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...
July 2016: Journal of Addiction Medicine
David Farabee, Maureen Hillhouse, Timothy Condon, Barbara McCrady, Kathryn McCollister, Walter Ling
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...
July 2016: Contemporary Clinical Trials
Joshua D Lee, Peter D Friedmann, Timothy W Kinlock, Edward V Nunes, Tamara Y Boney, Randall A Hoskinson, Donna Wilson, Ryan McDonald, John Rotrosen, Marc N Gourevitch, Michael Gordon, Marc Fishman, Donna T Chen, Richard J Bonnie, James W Cornish, Sean M Murphy, Charles P O'Brien
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...
March 31, 2016: New England Journal of Medicine
Walter Ling, Maureen P Hillhouse, Andrew J Saxon, Larissa J Mooney, Christie M Thomas, Alfonso Ang, Abigail G Matthews, Albert Hasson, Jeffrey Annon, Steve Sparenborg, David S Liu, Jennifer McCormack, Sarah Church, William Swafford, Karen Drexler, Carolyn Schuman, Stephen Ross, Katharina Wiest, P Todd Korthuis, William Lawson, Gregory S Brigham, Patricia C Knox, Michael Dawes, John Rotrosen
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)...
August 2016: Addiction
Michael S Gordon, Timothy W Kinlock, Frank J Vocci, Terrence T Fitzgerald, Asli Memisoglu, Bernard Silverman
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...
December 2015: Journal of Substance Abuse Treatment
Mark W Parrino, Angelo Giovanni Icro Maremmani, Paul N Samuels, Icro Maremmani
There has been a well documented increase in the use and abuse of prescription opioids and heroin in the United States and other parts of the world. There has also been an increasing focus to increase access to the use of medications (methadone, buprenorphine, Naltrexone/Vivitrol) for opioid addicted individuals under legal supervision. As policymakers engage in strategic initiatives to better prevent and effectively treat chronic opioid addiction, both in the United States and other countries, there are a number of unintended consequences, complicating how best to increase access to effective treatment...
2015: Journal of Addictive Diseases
Joshua D Lee, Ryan McDonald, Ellie Grossman, Jennifer McNeely, Eugene Laska, John Rotrosen, Marc N Gourevitch
BACKGROUND AND AIMS: Relapse to addiction following incarceration is common. We estimated the feasibility and effectiveness of extended-release naltrexone (XR-NTX) as relapse prevention among opioid-dependent male adults leaving a large urban jail. DESIGN: Eight-week, proof-of-concept, open-label, non-blinded randomized effectiveness trial. SETTING: New York City jails and Bellevue Hospital Center Adult Primary Care clinics, USA. PARTICIPANTS: From January 2010 to July 2013, 34 opioid-dependent adult males with no stated interest in agonist treatments (methadone, buprenorphine) received a counseling and referral intervention and were randomized to XR-NTX (n = 17) versus no medication (n = 17) within one week prior to jail release...
June 2015: Addiction
Joshua D Lee, Peter D Friedmann, Tamara Y Boney, Randall A Hoskinson, Ryan McDonald, Michael Gordon, Marc Fishman, Donna T Chen, Richard J Bonnie, Timothy W Kinlock, Edward V Nunes, James W Cornish, Charles P O'Brien
BACKGROUND: Extended-release naltrexone (XR-NTX, Vivitrol; Alkermes Inc.) is an injectable monthly sustained-release mu opioid receptor antagonist. XR-NTX is a potentially effective intervention for opioid use disorders and as relapse prevention among criminal justice system (CJS) populations. METHODS: This 5-site open-label randomized controlled effectiveness trial examines whether XR-NTX reduces opioid relapse compared with treatment as usual (TAU) among community dwelling, non-incarcerated volunteers with current or recent CJS involvement...
March 2015: Contemporary Clinical Trials
Paolo Mannelli, Li-Tzy Wu, Kathleen S Peindl, Marvin S Swartz, George E Woody
BACKGROUND: The approval of extended release injectable naltrexone (XR-NTX; Vivitrol(®)) has introduced a new option for treating opioid addiction, but studies are needed to identify its place within the spectrum of available therapies. The absence of physiological opioid dependence is a necessary and challenging first step for starting XR-NTX. Outpatient detoxification gives poor results and inpatient detoxification is either unavailable or too brief for the physiological effects of opioids to resolve...
May 1, 2014: Drug and Alcohol Dependence
Walter Ling, Larissa Mooney, Min Zhao, Suzanne Nielsen, Matthew Torrington, Karen Miotto
Pharmacotherapies for opioid addiction under active development in the US include lofexidine (primarily for managing withdrawal symptoms) and Probuphine®, a distinctive mode of delivering buprenorphine for six months, thus relieving patients, clinicians, and regulatory personnel from most concerns about diversion, misuse, and unintended exposure in children. In addition, two recently approved formulations of previously proven medications are in early phases of implementation. The sublingual film form of buprenorphine + naloxone (Suboxone®) provides a less divertible, more quickly administered, more child-proof version than the buprenorphine + naloxone sublingual tablet...
2011: Substance Abuse and Rehabilitation
Yahiya Y Syed, Gillian M Keating
Naltrexone is a μ-opioid receptor antagonist that blocks the euphoric effects of heroin and prescription opioids. In order to improve treatment adherence, a once-monthly, intramuscular, extended-release formulation of naltrexone (XR-NTX) [VIVITROL(®)] has been developed, and approved in the USA and Russia for the prevention of relapse to opioid dependence, after opioid detoxification. The clinical efficacy of this formulation in patients with opioid dependence was demonstrated in a 24-week, randomized, double-blind, placebo-controlled, multicentre, phase III trial (ALK21-013; n = 250)...
October 2013: CNS Drugs
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