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

Phase 3

Completed

• Conditions: Alcohol Dependence
• Interventions: Drug: VIVITROL 380 mg; Drug: Placebo for VIVITROL 380 mg

• Registration Number: NCT00501631
• Lead Sponsor: Alkermes, Inc.

Brief Summary

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

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.

Study Timeline

• Study Start: 2007-07
• Study First Submitted: 2007-07-12
• Study First Submitted QC: 2007-07-12
• Study First Posted: 2007-07-16
• Primary Completion: 2011-01
• Study Completion: 2011-03
• Results First Submitted: 2011-03-23
• Results First Submitted QC: 2011-03-23
• Results First Posted: 2011-04-13
• Status Verified: 2011-09
• Last Update Submitted: 2011-09-20
• Last Update Posted: 2011-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VIVITROL 380 mg	VIVITROL 380 mg	Administered via intramuscular (IM) injection once every 4 weeks.
Placebo for VIVITROL 380 mg	Placebo for VIVITROL 380 mg	Administered via IM injection once every 4 weeks.

Primary Outcome Measures

Name	Time	Method
Cumulative Percentage of Participants by Heavy Drinking Rate	up to 12 weeks	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).

Secondary Outcome Measures

Name	Time	Method
Longer-term Safety of VIVITROL	up to 1 year	Number of subjects reporting at least 1 treatment-emergent adverse event (TEAE) while on study.