alk21-006: long-term study of medisorb® naltrexone (vivitrol®)

Conditions: Alcoholism

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.

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)

Keywords: alcoholism alcohol dependence