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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
T V Agibalova, T R Petrosian, A G Kuznetsov, G L Gurevich, S A Shuvalov
This article presents the results of a study of clinical features of the development and course of alcohol dependence in patients with posttraumatic stress disorder (PTSD) in comparison with alcohol-dependent patients without PTSD. The highly progressive course, continuous alcohol consumption, high alcohol tolerance, rapidly emerged altered forms of alcohol intoxication, alcohol amnesias, alcohol withdrawal with the prevalence of psychopathological component, and more pronounced social and somatic consequences of alcohol abuse were characteristic of the PTSD group...
2013: Zhurnal Nevrologii i Psikhiatrii Imeni S.S. Korsakova
Maria A Sullivan, Adam Bisaga, John J Mariani, Andrew Glass, Frances R Levin, Sandra D Comer, Edward V Nunes
BACKGROUND: FDA approval of long-acting injectable naltrexone (Vivitrol) for opioid dependence highlights the relevance of understanding mechanisms of antagonist treatment. Principles of learning suggest an antagonist works through extinguishing drug-seeking behavior, as episodes of drug use ("testing the blockade") fail to produce reinforcement. We hypothesized that opiate use would moderate the effect of naltrexone, specifically, that opiate-positive urines precede dropout in the placebo group, but not in the active-medication groups...
November 1, 2013: Drug and Alcohol Dependence
Suchitra Krishnan-Sarin, Stephanie O'Malley, John H Krystal
Developing pharmacotherapies to treat alcohol dependence and associated health problems traditionally has been based on gaining a better understanding of the neuroscience underlying alcohol-drinking behavior. To date, three medications have been approved for the treatment of alcohol dependence: disulfiram (Antabuse®), naltrexone (Revia®, Vivitrol®, and Naltrel®), and acamprosate (Campral®). However, these medications have modest efficacy, and there is a great need for newer medications that target different neurochemical systems and which could be used either as adjunctive treatments or to treat subpopulations of drinkers...
2008: Alcohol Research & Health: the Journal of the National Institute on Alcohol Abuse and Alcoholism
Larissa J Mooney, Suzanne Nielsen, Andrew Saxon, Maureen Hillhouse, Christie Thomas, Albert Hasson, Don Stablein, Jennifer McCormack, Robert Lindblad, Walter Ling
BACKGROUND: Effective medications to treat cocaine dependence have not been identified. Recent pharmacotherapy trials demonstrate the potential efficacy of buprenorphine (BUP) (alone or with naltrexone) for reducing cocaine use. The National Institute on Drug Abuse Clinical Trials Network (CTN) launched the Cocaine Use Reduction with Buprenorphine (CURB) investigation to examine the safety and efficacy of sublingual BUP (as Suboxone®) in the presence of extended-release injectable naltrexone (XR-NTX, as Vivitrol®) for the treatment of cocaine dependence...
March 2013: Contemporary Clinical Trials
Mack C Mitchell, Asli Memisoglu, Bernard L Silverman
OBJECTIVE: Naltrexone (Revia, Vivitrol) is recognized as having the potential for hepatotoxicity. We evaluated the safety of intramuscular extended-release naltrexone (XR-NTX) in a cohort of patients with a high prevalence of chronic hepatitis C virus (HC V) and HIV infection undergoing treatment for opioid dependence. METHOD: A total of 250 (88% male) opioid-dependent patients were randomized to receive monthly injections of XR-NTX 380 mg or placebo. Of the 250 subjects, 222 (88...
November 2012: Journal of Studies on Alcohol and Drugs
Robert Swift, David W Oslin, Mark Alexander, Robert Forman
OBJECTIVE: The efficacy of naltrexone (Revia, Vivitrol) for the treatment of alcohol dependence exhibits a high degree of heterogeneity. The aim of the current study was to evaluate the extent to which variability in patient adherence to treatment contributed to the range of clinical responses observed during naltrexone treatment. METHOD: A systematic review was conducted of efficacy trials of naltrexone for the treatment of alcohol dependence to evaluate the level of adherence monitoring...
November 2011: Journal of Studies on Alcohol and Drugs
Ron A Cisler, Bernard L Silverman, Irina Gromov, David R Gastfriend
OBJECTIVES: : The impact of intramuscular, injectable, extended-release naltrexone (XR-NTX; Vivitrol) on counseling and support group participation was examined in a post hoc analysis of a 24-week, randomized, double-blind study in 624 alcohol-dependent adults, most of whom were nonabstinent at baseline. METHODS: : Patients were offered 6 monthly injections of XR-NTX 380 mg, XR-NTX 190 mg, or placebo (n = 205, 210, and 209, respectively) and 12 sessions of manualized brief counseling...
September 2010: Journal of Addiction Medicine
David R Gastfriend
Extended-release naltrexone (XR-NTX; Vivitrol), developed to address poor adherence in addictive disorders, is approved for use in alcohol and opioid-dependence disorders. In alcohol-dependent adults with ≥ 4-day initial abstinence, XR-NTX increased initial and 6-month abstinence. An fMRI study found that XR-NTX attenuated the salience of alcohol visual and olfactory cues in the absence of alcohol, and post hoc analyses demonstrated efficacy even during high cue-exposure holiday periods. Safety and tolerability have generally been good, without adverse hepatic impact or intractable acute pain management...
January 2011: Annals of the New York Academy of Sciences
Jae Kennedy, Aaron Dipzinski, John Roll, Joseph Coyne, Elizabeth Blodgett
OBJECTIVES: Pharmacotherapeutic treatments for drug addiction offer new options, but only if they are affordable for patients. The objective of this study is to assess the current availability and cost of five common antiaddiction medications in the largest federal medication insurance program in the US, Medicare Part D. METHODS: In early 2010, we collected coverage and cost data from 41 Medicare Part D prescription drug plans (PDPs) and 45 Medicare Advantage Plans (MAPs) in Washington State...
April 1, 2011: Drug and Alcohol Dependence
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