ALK21-006: Long-Term Study of Medisorb® Naltrexone (VIVITROL®) - Full Text View

Purpose

This was a Phase 3 multicenter randomized, open-label, safety study assessing the safety of repeat doses of Medisorb® naltrexone 380 mg (VIVITROL®) administered for up to 1 year to adults with alcohol and/or opioid dependence as defined by Diagnostic and Statistical Manual of Mental Health Disorders (DSM-IV) criteria. Eligible subjects were randomized in a 6:1 ratio to receive 1 of the following regimens: a single intramuscular (IM) injection of VIVITROL administered once every 4 weeks or oral naltrexone 50 mg administered daily.

Condition	Intervention	Phase
Alcoholism	Drug: Medisorb naltrexone 380 mg Drug: Oral naltrexone 50 mg	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Randomized, Open Label, Long-Term, Multi-Center Study of the Safety of Medisorb® Naltrexone

Resource links provided by NLM:

MedlinePlus related topics: Alcoholism

Drug Information available for: Naltrexone Naltrexone hydrochloride

U.S. FDA Resources

Further study details as provided by Alkermes:

Primary Outcome Measures:

Number of Subjects Reporting at Least 1 Treatment-emergent Adverse Event (TEAE) While on Study [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]
A TEAE was defined as any adverse event (AE) that started or worsened on or after the administration of the first dose of study medication through 30 days after the end of study treatment.

Enrollment:	436
Study Start Date:	August 2003
Study Completion Date:	March 2005
Primary Completion Date:	March 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Medisorb naltrexone 380 mg (VIVITROL)	Drug: Medisorb naltrexone 380 mg Administered via intramuscular (IM) injection once every 4 weeks for up to 1 year. Other Names: VIVITROL® 380 mg Naltrexone for extended-release injectable suspension
Active Comparator: Oral naltrexone 50 mg	Drug: Oral naltrexone 50 mg Tablet taken orally once daily for up to 1 year Other Name: Revia®

Detailed Description:

Safety evaluations included physical examinations, electrocardiograms (ECGs), laboratory measures (including plasma concentrations of naltrexone and 6β-naltrexol), assessments of injection sites, and adverse events (AEs).

All subjects received psychosocial support at each study visit for the duration of the study, with interim telephone contact 2 weeks after each monthly visit.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Primary Inclusion Criteria:

Current diagnosis of DSM-IV alcohol dependence and/or diagnosis of DSM-IV opiate dependence within 3 months prior to screening
18 years or older
Desire to seek treatment for alcohol and/or opiate abuse/dependence
Agree to use contraception for the study duration if of childbearing potential
Written informed consent and willingness to perform study procedures
Stable address and phone and at least 1 source of contact information (eg, family member, significant other)

Primary Exclusion Criteria:

Presence of opiates in the urine (as determined by urine drug test) on Day 0 prior to naltrexone treatment
Clinically significant medical/psychological condition or abnormality at screening (ie, physical examination, electrocardiogram [ECG], hematology or blood chemistry evaluation, or urinalysis findings)
Clinically significant active hepatitis or hepatic failure evidenced by 1 of the following: aspartate transaminase (AST) or alanine transaminase (ALT) higher than 3 times the upper limit of normal (3xULN), hyperbilirubinemia (bilirubin >10% above ULN), creatine phosphokinase (CPK) higher than 10xULN, prolonged prothrombin time(international normalized ratio ≥1.7), ascites, or esophageal variceal disease
Manifestation of suicidal ideation, psychotic symptoms (including significant violent behavior), or psychiatric disorders that would compromise ability to complete the study
Participation in a formal methadone program currently or within prior 3 years
More than 2 prior medically supervised detoxification treatments in prior 3 years
Pregnancy or lactation
Current prescribed opiate therapy, or receipt of opiates within 7 days prior to study drug dosing, or ongoing medical condition likely to require prescribed opiate therapy during study period
Failed naloxone challenge on Day 0 (the challenge could be repeated up to 2 times, with at least 24 hours between attempts)
Participation in a clinical trial within 30 days of screening
Previous enrollment in a VIVITROL clinical trial
Receipt of any drug product administered as a gluteal injection within 180 days prior to Day 0 or anticipated need for gluteal injections during study period
Intolerance and/or hypersensitivity to naltrexone, naloxone, or polylactide-co-polymers such as polylactide-co-glycolide (PLG)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01218997

Sponsors and Collaborators

Alkermes

Investigators

Study Director:

Bernard L. Silverman, MD

Alkermes

More Information

No publications provided

Responsible Party:	Bernard L. Silverman, MD / VP, Clinical Development, Alkermes, Inc.
ClinicalTrials.gov Identifier:	NCT01218997 History of Changes
Other Study ID Numbers:	ALK21-006
Study First Received:	October 8, 2010
Results First Received:	November 8, 2010
Last Updated:	December 27, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by Alkermes:

Alcoholism
Alcohol dependence

Additional relevant MeSH terms:

Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Mental Disorders
Naltrexone
Narcotic Antagonists

Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 21, 2013