Alcohol Dependence MedDRA version: 9.1 Level: LLT Classification code 10001590 Term: Alcohol addiction
Conditions
Interventions
Product Name: Vivitrol
Pharmaceutical Form: Powder and solvent for suspension for injection
INN or Proposed INN: Naltrexone
CAS Number: 16590-41-3
Concentration unit: mg milligram(s)
Concentration typ
Sponsors
Alkermes Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Capable of understanding and complying with the protocol, and has signed the informed consent document • Current diagnosis of alcohol dependence, meeting at least 5 of the DSM-IV criteria • 18 years of age or older • Must be expected to complete inpatient treatment for alcohol dependence within 24 hours of randomization • Must have 7-21 days, inclusive, of inpatient treatment for alcohol dependence prior to first dose • Must be free of symptoms and/or signs of acute alcohol withdrawal on the day of randomization • Must have a non-custodial stable residence and a telephone, plus one contact with verifiable address and telephone number • Must have a negative urine toxicological screen for opioids and benzodiazepines on the day of randomization • If subject is female and of child-bearing potential, she must agree to use an acceptable method of contraception for the duration of the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Pregnancy (ie, positive urine and/or serum pregnancy test) and/or currently breastfeeding • Clinically significant medical condition or observed abnormalities (including: physical examination, ECG, laboratory evaluation, and/or urinalysis findings) • Evidence of hepatic failure including: ascites, bilirubin >10% above upper limit of normal and/or esophageal variceal disease • Active hepatitis and/or aspartate aminotransferase (AST), alanine aminotransferase (ALT) > 3x the upper limit of normal • History of pancreatitis • Current major depression with suicidal ideation, psychosis, bipolar disorder, or any psychiatric disorder that would compromise the subject’s ability to complete the study. • Current dependence (within the past year) to benzodiazepines, opioids or cocaine by DSM IV criteria • Current seizure disorder • Current eating disorder • Use of any opioids and/or methadone within 14 days prior to the screening visit, or subjects likely to require opioid therapy during the study period • Use of oral naltrexone, acamprosate, or disulfiram within 30 days prior to screening • Use of any excluded medication at screening or anticipated/required use during the study period • Receipt of any approved or investigational depot product administered into the gluteal muscle within 6 months of screening • Participation in a clinical trial of a pharmacological agent within 30 days prior to screening • Previous enrollment in a Vivitrol (or Medisorb® Naltrexone) clinical trial • Known intolerance and/or hypersensitivity to naltrexone, carboxymethylcellulose, or PLG • Any finding that in the view of the Principal Investigator would compromise the subject’s ability to fulfill the protocol visit schedule or visit requirements. • Subjects on parole or probation, or those with pending legal proceedings that have the potential for incarceration during the study period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the clinical efficacy of 12 weeks of treatment with Vivitrol (naltrexone for extended-release injectable suspension, 380 mg) vs placebo administered to adults every 4 weeks upon discharge from inpatient treatment for alcohol dependence.;Secondary Objective: To evaluate the clinical safety and efficacy of Vivitrol administered every 4 weeks in the treatment of alcohol dependent adults as assessed by secondary and exploratory endpoints. To assess longer-term safety, durability of effect, and health economic measures.;Primary end point(s): The primary endpoint of the study is the percent of days abstinent from any alcohol. | — |
Countries
Austria, Germany
Outcome results
None listed