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

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

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.

Study Overview

• Status: Completed
• Conditions: Alcohol Dependence
• Intervention / Treatment: Drug: VIVITROL 380 mg; Drug: Placebo for VIVITROL 380 mg

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 Type: Interventional
• Enrollment (Actual): 300
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: VIVITROL 380 mg; Administered via intramuscular (IM) injection once every 4 weeks.	Drug: VIVITROL 380 mg; Administered via IM injection once every 4 weeks.; Other Names: naltrexone for extended-release injectable suspension; Medisorb naltrexone
PLACEBO_COMPARATOR: Placebo for VIVITROL 380 mg; Administered via IM injection once every 4 weeks.	Drug: Placebo for VIVITROL 380 mg; Administered via IM injection once every 4 weeks.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Alkermes, Inc.

Study record dates

Study Major Dates

• Study Start: July 1, 2007
• Primary Completion (ACTUAL): January 1, 2011
• Study Completion (ACTUAL): March 1, 2011

Study Registration Dates

• First Submitted: July 12, 2007
• First Submitted That Met QC Criteria: July 12, 2007
• First Posted (ESTIMATE): July 16, 2007

Study Record Updates

• Last Update Posted (ESTIMATE): September 22, 2011
• Last Update Submitted That Met QC Criteria: September 20, 2011
• Last Verified: September 1, 2011

More Information

Terms related to this study

• Keywords: Alcoholism; Addiction; Inpatient detoxification
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Alcoholism; Physiological Effects of Drugs; Peripheral Nervous System Agents; Sensory System Agents; Narcotic Antagonists; Alcohol Deterrents; Naltrexone
• Other Study ID Numbers: ALK21-014