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

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Alkermes

Status and phase

Completed
Phase 3

Conditions

Alcoholism

Treatments

Drug: Medisorb naltrexone 380 mg
Drug: Oral naltrexone 50 mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT01218997
ALK21-006

Details and patient eligibility

About

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.

Full 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.

Enrollment

436 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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)

Trial design

436 participants in 2 patient groups

Medisorb naltrexone 380 mg (VIVITROL)
Experimental group
Treatment:
Drug: Medisorb naltrexone 380 mg
Oral naltrexone 50 mg
Active Comparator group
Treatment:
Drug: Oral naltrexone 50 mg

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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