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

NCT00501631 | Completed Phase 3 Results

• 1 other identifier: ALK21-014
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Alcohol Dependence

Keywords

Addiction; Alcoholism; Inpatient detoxification

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Longer-term Safety of VIVITROL

  up to 1 year

Study Arms (2)

VIVITROL 380 mg

ACTIVE COMPARATOR

Administered via intramuscular (IM) injection once every 4 weeks.

Drug: VIVITROL 380 mg

Placebo for VIVITROL 380 mg

PLACEBO COMPARATOR

Administered via IM injection once every 4 weeks.

Drug: Placebo for VIVITROL 380 mg

Interventions

VIVITROL 380 mg DRUG

Administered via IM injection once every 4 weeks.

Also known as: naltrexone for extended-release injectable suspension, Medisorb naltrexone

VIVITROL 380 mg

Placebo for VIVITROL 380 mg DRUG

Administered via IM injection once every 4 weeks.

Placebo for VIVITROL 380 mg

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Alkermes, Inc.: lead

MeSH Terms

Conditions

Alcoholism; Behavior, Addictive

Interventions

vivitrol; Naltrexone

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Compulsive Behavior; Impulsive Behavior; Behavior

Intervention Hierarchy (Ancestors)

Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Bernard L. Silverman, MD
• Organization: Alkermes, Inc.

bernard.silverman@alkermes.com

1-781-609-6000

Study Officials

• Bernard L. Silverman, MD

  Alkermes, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2007
• First Posted: July 16, 2007
• Study Start: July 1, 2007
• Primary Completion: January 1, 2011
• Study Completion: March 1, 2011
• Last Updated: September 22, 2011
• Results First Posted: April 13, 2011

Record last verified: 2011-09