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

• ClinicalTrials.gov Identifier: NCT01218997
• Recruitment Status: Completed
• First Posted: October 13, 2010
• Results First Posted: December 13, 2010
• Last Update Posted: January 4, 2011
• Sponsor: Alkermes, Inc.
• Information provided by: Alkermes, Inc.

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Alcoholism	Drug: Medisorb naltrexone 380 mg; Drug: Oral naltrexone 50 mg	Phase 3

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 436 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Randomized, Open Label, Long-Term, Multi-Center Study of the Safety of Medisorb® Naltrexone
• Study Start Date: August 2003
• Actual Primary Completion Date: March 2005
• Actual Study Completion Date: March 2005

Arms and Interventions

Arm	Intervention/treatment
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®

Outcome Measures

Primary Outcome Measures :

1. Number of Subjects Reporting at Least 1 Treatment-emergent Adverse Event (TEAE) While on Study [ Time Frame: up to 1 year ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

Sponsors and Collaborators

Alkermes, Inc.

Investigators

• Study Director: Bernard L. Silverman, MD; Alkermes, Inc.

More Information

• Responsible Party: Bernard L. Silverman, MD / VP, Clinical Development, Alkermes, Inc.
• ClinicalTrials.gov Identifier: NCT01218997
• Other Study ID Numbers: ALK21-006
• First Posted: October 13, 2010
• Results First Posted: December 13, 2010
• Last Update Posted: January 4, 2011
• Last Verified: December 2010

Keywords provided by Alkermes, Inc.:

Alcoholism; Alcohol dependence

Additional relevant MeSH terms:

Alcoholism; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Naltrexone; Alcohol Deterrents; Narcotic Antagonists; Physiological Effects of Drugs; Sensory System Agents; Peripheral Nervous System Agents