ALK21-014: Efficacy and Safety of Medisorb® Naltrexone (VIVITROL®) After Enforced Abstinence

Study Overview
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Brief Summary
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VIVITROL is indicated for the treatment of alcohol dependence in patients who are able to abstain from alcohol in an outpatient setting prior to initiation of treatment with VIVITROL. This Phase 3B trial was designed to evaluate the efficacy and safety of VIVITROL versus placebo. Injections were administered to patients in whom abstinence was enforced by a period of inpatient hospitalization of 7 to 21 days.

Detailed Description
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The study consisted of 2 parts, Part A and Part B. Part A was a double-blind, placebo-controlled assessment of safety and efficacy of VIVITROL versus placebo for 3 months. Part B was an open-label extension to assess longer-term safety, durability of effect, and health economics of VIVITROL when administered for up to 9 additional months.

Official Title
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Efficacy and Safety of VIVITROL® in Adults Completing Inpatient Treatment for Alcohol Dependence

Conditions
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Alcohol Dependence

Intervention / Treatment
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* Drug: VIVITROL 380 mg
* Drug: Placebo for VIVITROL 380 mg


Participation Criteria
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Eligibility Criteria
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Primary Inclusion Criteria: Current diagnosis of alcohol dependence, meeting at least 5 of DSM-IV criteria 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 Negative urine toxicological screen for opioids on the day of randomization Women of childbearing potential must agree to use an approved method of contraception for the study duration Primary Exclusion Criteria: Pregnancy or lactation Evidence of hepatic failure including: ascites, bilirubin >10% above upper limit of normal and/or esophageal variceal disease Current dependence (within the past year) to benzodiazepines, opioids or cocaine by DSM-IV criteria 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 14 days prior to screening Known intolerance and/or hypersensitivity to naltrexone, carboxymethylcellulose, or PLG Parole, probation, or pending legal proceedings having the potential for incarceration during the study period

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: VIVITROL 380 mg<br>Administered via intramuscular (IM) injection once every 4 weeks. | Drug: VIVITROL 380 mg<br>* Administered via IM injection once every 4 weeks.<br>* Other names: Medisorb naltrexone;|
| Placebo Comparator: Placebo for VIVITROL 380 mg<br>Administered via IM injection once every 4 weeks. | Drug: Placebo for VIVITROL 380 mg<br>* Administered via IM injection once every 4 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative Percentage of Participants by Heavy Drinking Rate | Cumulative percentage (%) of subjects reporting heavy drinking by category reflecting the various cut-offs for percentage of days that were heavy drinking days. A heavy drinking day was defined as 4 or more alcohol drinks in 1 day for women, and 5 or more alcohol drinks in 1 day for men. The Timeline Follow-Back (TLFB) method (Sobell & Sobell: Humana Press, 1992) was utilized to collect subjects' daily drinking information (ie, the number of drinks consumed per day per subject which was retrospectively recalled and recorded in a diary). | up to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Longer-term Safety of VIVITROL | Number of subjects reporting at least 1 treatment-emergent adverse event (TEAE) while on study. | up to 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Addiction, Alcoholism, Inpatient detoxification