Phase 3
Completed N=624
ALK21-003: Study of Medisorb® Naltrexone (VIVITROL®) in Alcohol-Dependent Adults
Alcoholism
Source: ClinicalTrials.gov NCT01218958 ↗
Enrolled (actual)
624
Serious AEs
5.8%
Results posted
Dec 2010
Primary outcomePrimary: Percentage of Heavy Drinking Days Over the Treatment Period — 14.75; 10.23; 19.77 Percentage of days — p=0.0245
Summary
This was a Phase 3, multicenter, randomized, double-blind, placebo-controlled study conducted in subjects diagnosed with alcohol dependence as defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th Ed. (DSM-IV). Subjects were randomized (2:2:1:1) to receive intramuscular (IM) injections of Medisorb® naltrexone 190 mg, Medisorb naltrexone 380 mg, placebo for Medisorb naltrexone 190 mg, or placebo for Medisorb naltrexone 380 mg (VIVITROL®). Study drug was administered every 4 weeks for a total of 6 injections.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Heavy Drinking Days Over the Treatment Period |
14.75; 10.23; 19.77 | 0.0245 sig |
| SECONDARY Number of Participants Reporting at Least 1 Treatment-emergent Adverse Event (TEAE) |
190; 187; 181 | — |
Eligibility Criteria
Primary Inclusion Criteria:
- Diagnosis of alcohol dependence based on Diagnostic and Statistical Manual of Mental Disorders, 4th Ed. (DSM-IV) criteria
- Male or non-pregnant, non-lactating female
- Able to provide TimeLine Follow-Back (TLFB) alcohol consumption information for 90-day period before detoxification and/or screening
- At least 2 episodes of heavy alcohol drinking per week during the 30 days before detoxification and/or screening
- Negative urine toxicological screen for opiates on day of randomization
- Noncustodial, stable residence and phone plus 1 contact with verifiable address and phone
Primary Exclusion Criteria:
- Evidence of hepatic failure including: ascites, prolonged prothrombin time (PT) (international normalized ratio [INR] ≥1.7), bilirubin >10% above upper limit of normal (ULN) and/or esophageal variceal disease
- Active hepatitis and/or aspartate aminotransferase (AST) or alanine aminotransferase (ALT) higher than 3xULN
- History of pancreatitis
- Major depression with suicidal ideation, psychosis, bipolar disorder, or psychiatric disorders that would compromise subject's ability to complete the study
- Current dependence (within past year) per DSM-IV criteria to benzodiazepines, opioids or cocaine
- Use of benzodiazepines and/or Ambien® (zolpidem tartrate) within 7 days prior to first dose of study medication
- Greater than 7 days inpatient treatment for substance use disorders within 30 days of randomization
- Use of any opioids and/or methadone within 14 days of screening, or likely requiring opioid therapy during study period
- Use of oral naltrexone or disulfiram within 14 days of screening
- Known intolerance and/or hypersensitivity to naltrexone, carboxymethylcellulose, or polylactide-co-glycolide (PLG)
Data sourced from ClinicalTrials.gov (NCT01218958). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.