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

NCT ID: NCT01218997

Last Updated: 2011-01-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 436 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-08-31
• Study Completion Date: 2005-03-31

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.

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.

Conditions

Alcoholism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Medisorb naltrexone 380 mg (VIVITROL)

Group Type: EXPERIMENTAL

Medisorb naltrexone 380 mg

Intervention Type: DRUG

Administered via intramuscular (IM) injection once every 4 weeks for up to 1 year.

Oral naltrexone 50 mg

Group Type: ACTIVE_COMPARATOR

Oral naltrexone 50 mg

Intervention Type: DRUG

Tablet taken orally once daily for up to 1 year

Interventions

Medisorb naltrexone 380 mg

Administered via intramuscular (IM) injection once every 4 weeks for up to 1 year.

Intervention Type: DRUG

Oral naltrexone 50 mg

Tablet taken orally once daily for up to 1 year

Intervention Type: DRUG

Other Intervention Names

VIVITROL® 380 mg; Naltrexone for extended-release injectable suspension; Revia®

Eligibility Criteria

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)

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alkermes, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Alkermes, Inc.

Principal Investigators

Bernard L. Silverman, MD

Role: STUDY_DIRECTOR

Alkermes, Inc.

Other Identifiers

ALK21-006

Identifier Type: -

Identifier Source: org_study_id