Efficacy and Safety of Vivitrol® After Enforced Abstinence - Full Text View

Sponsors and Collaborators:	Alkermes Kendle International
Information provided by:	Alkermes
ClinicalTrials.gov Identifier:	NCT00501631

Purpose

This is a phase IIIB trial designed to evaluate the clinical efficacy and safety of Vivitrol® (naltrexone for extended-release injectable suspension, 380 mg) versus placebo administered to adults upon discharge from inpatient treatment for alcohol dependence.

Condition	Intervention	Phase
Alcohol Dependence	Drug: Vivitrol® (naltrexone for extended-release injectable susp.) Drug: Placebo	Phase III

MedlinePlus related topics: Alcoholism

Drug Information available for: Naltrexone Naltrexone hydrochloride Ethanol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment
Official Title:	Efficacy and Safety of Vivitrol® in Adults Completing Inpatient Treatment for Alcohol Dependence

Further study details as provided by Alkermes:

Primary Outcome Measures:

To compare the response rate based on heavy drinking days between patients treated with Vivitrol® and placebo [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Percent heavy drinking days [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]
Percent days abstinent [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]
Days to first drinking day [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]
Days to first heavy drinking day [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]
Obsessive-Compulsive Drinking Scale scores [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]
Gamma glutamyl-transferase levels [ Time Frame: up to 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	300
Study Start Date:	July 2007
Estimated Study Completion Date:	August 2010
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Vivitrol 380mg (naltrexone for extended-release injectable suspension)	Drug: Vivitrol® (naltrexone for extended-release injectable susp.) Vivitrol (naltrexone for extended-release injectable suspension) IM monthly injection
2: Placebo Comparator Placebo for Vivitrol 380mg	Drug: Placebo IM monthly injection 380mg

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Current diagnosis of alcohol dependence, meeting at least 5 of the DSM-IV criteria
Must be expected to complete inpatient treatment for alcohol dependence within 24 hours of randomization
Must have a negative urine toxicological screen for opioids on the day of randomization
If subject is female and of child-bearing potential, she must agree to use a highly effective method of contraception for the duration of the study

Exclusion Criteria:

Pregnancy (ie, positive urine and/or serum pregnancy test) and/or currently breastfeeding
Evidence of hepatic failure including: ascites, bilirubin >10% above upper limit of normal and/or esophageal variceal disease
Current dependence (within the past year) to benzodiazepines, opioids or cocaine by DSM IV criteria
Use of any opioids and/or methadone within 14 days prior to the screening visit, or subjects likely to require opioid therapy during the study period
Use of oral naltrexone, acamprosate, or disulfiram within 14 days prior to screening
Participation in a clinical trial of a pharmacological agent within 30 days prior to screening
Previous enrollment in a Vivitrol (or Medisorb® Naltrexone) clinical trial
Known intolerance and/or hypersensitivity to naltrexone, carboxymethylcellulose, or PLG
Subjects on parole or probation, or those with pending legal proceedings that have the potential for incarceration during the study period

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00501631

Contacts

Contact: Petra Falkenstein

+49-89-99 39 13 350

falkenstein.petra@kendle.com

Locations

Austria
Bundesamt fur Sicherheit im	Recruiting
Wien, Austria, 1030
Germany
Zentralinstitut fur Seelische Gesundheit, Klinic fur Abhangiges Verhalten und Suchtmedizin	Recruiting
Mannheim, Germany, 68159
Contact: Rosemarie Kramer Kramer rosie.kraemer@zi-mannheim.de

Sponsors and Collaborators

Alkermes

Kendle International

Investigators

Study Chair:	Karl Mann, Prof, MD	University of Heidelberg
Principal Investigator:	Anil Batra, Prof, MD	University Hospital Tuebingen
Principal Investigator:	Michael Berner, MD	University Hospital Freiburg
Principal Investigator:	Martin Driessen, Prof, MD	University of Muenster
Principal Investigator:	Andreas Fallgatter, Prof, MD	Univeristy of Wuerzburg
Principal Investigator:	Christophe Fehr, MD	Johannes Gutenberg University Mainz
Principal Investigator:	Wolfgang Gaebel, Prof, MD	Heinrich-Heine University, Duesseldorf
Principal Investigator:	Gerhard Grunder, Prof, MD	RWTH Aachen University
Principal Investigator:	Ursula Havemann-Reinecke, Prof, MD	University of Goettingen
Principal Investigator:	Andreas Heinz, Prof, MD	University of Berlin, Charite
Principal Investigator:	Klaus Junghanns, MD	Univeristy of Lubeck
Principal Investigator:	Gudrun Richter, MD	Angermunde Hospital
Principal Investigator:	Norbert Scherbaum, Prof, MD	Univeristat Duisburg-Essen
Principal Investigator:	Christian Schutz, Prof, MD	University of Bonn - Site Closed
Principal Investigator:	Norbert Wodarz, MD	University of Regensburg
Principal Investigator:	Christian Haasen, Prof	Universitätsklinikum Hamburg-Eppendorf
Principal Investigator:	Martin Siepmann, Prof, MD	ABX-CRO Advanced Pharmaceutical Services GmbH
Principal Investigator:	Wolfgang Fleischhacker, Prof	Innsbruck University Clinics
Principal Investigator:	Michael Musalek, Prof	Anton Proksch Institute
Principal Investigator:	Friedrich Wurst, Prof	Psychiatric University Hospital
Principal Investigator:	Josef Marksteiner, Prof	Landeskrankenhaus Klagenfurt

More Information

Responsible Party:	Kendle International ( Petra Falkenstein, Project Leader, Late Phase )
Study ID Numbers:	ALK21-014
Study First Received:	July 12, 2007
Last Updated:	November 25, 2008
ClinicalTrials.gov Identifier:	NCT00501631
Health Authority:	United States: Food and Drug Administration; Germany: Federal Institute for Drugs and Medical Devices; Austria: Bundesamt fur Sicherheit im

Keywords provided by Alkermes:

Addiction
Alcoholism
Inpatient detoxification

Study placed in the following topic categories:

Behavior, Addictive
Mental Disorders
Naltrexone
Alcoholism

Substance-Related Disorders
Disorders of Environmental Origin
Alcohol-Related Disorders
Ethanol

Additional relevant MeSH terms:

Sensory System Agents
Therapeutic Uses
Physiological Effects of Drugs
Narcotic Antagonists

Peripheral Nervous System Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009