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

NCT01218997 | Completed Phase 3 Results

• 1 other identifier: ALK21-006
• Study Type: interventional
• Target: 436
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Alcoholism

Keywords

Alcoholism; Alcohol dependence

Outcome Measures

Primary Outcomes (1)

• Number of Subjects Reporting at Least 1 Treatment-emergent Adverse Event (TEAE) While on Study

  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.

  up to 1 year

Study Arms (2)

Medisorb naltrexone 380 mg (VIVITROL)

EXPERIMENTAL

Drug: Medisorb naltrexone 380 mg

Oral naltrexone 50 mg

ACTIVE COMPARATOR

Drug: Oral naltrexone 50 mg

Interventions

Medisorb naltrexone 380 mg DRUG

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

Also known as: VIVITROL® 380 mg, Naltrexone for extended-release injectable suspension

Medisorb naltrexone 380 mg (VIVITROL)

Oral naltrexone 50 mg DRUG

Tablet taken orally once daily for up to 1 year

Also known as: Revia®

Oral naltrexone 50 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Current diagnosis of DSM-IV alcohol dependence and/or diagnosis of DSM-IV opiate dependence within 3 months prior to screening
• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Alkermes, Inc.: lead

MeSH Terms

Conditions

Alcoholism

Interventions

vivitrol; Naltrexone

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Bernard L. Silverman
• Organization: Alkermes, Inc.

bernard.silverman@alkermes.com

781-609-6000

Study Officials

• Bernard L. Silverman, MD

  Alkermes, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 8, 2010
• First Posted: October 13, 2010
• Study Start: August 1, 2003
• Primary Completion: March 1, 2005
• Study Completion: March 1, 2005
• Last Updated: January 4, 2011
• Results First Posted: December 13, 2010

Record last verified: 2010-12