Clinical trial NCT01218997: ALK21-006: Long-Term Study of Medisorb® Naltrexone (VIVITROL®)
Official title: A Randomized, Open Label, Long-Term, Multi-Center Study of the Safety of Medisorb® Naltrexone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Alcoholism
Keywords: Alcoholism
Alcohol dependence
Lead sponsor: Alkermes, Inc.
Sponsor class: INDUSTRY
First posted: 2010-10-13
Enrollment: 436
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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)

Primary outcomes:
measure: Number of Subjects Reporting at Least 1 Treatment-emergent Adverse Event (TEAE) While on Study
timeFrame: up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Alkermes, Inc.
name: Bernard L. Silverman, MD
role: STUDY_DIRECTOR
References: