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

Alcohol Dependence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00501631
• Other study ID #: ALK21-014
• Status: Completed
• Phase: Phase 3
• First received: July 12, 2007
• Last updated: September 20, 2011
• Start date: July 2007
• Est. completion date: March 2011

Study information

• Verified date: September 2011
• Source: Alkermes, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationGermany: Federal Institute for Drugs and Medical DevicesAustria: Federal Office for Safety in Health Care
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: March 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcohol Dependence
• Alcoholism

Intervention

Drug:
• VIVITROL 380 mg
Administered via IM injection once every 4 weeks.
• Placebo for VIVITROL 380 mg
Administered via IM injection once every 4 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alkermes, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Longer-term Safety of VIVITROL	Number of subjects reporting at least 1 treatment-emergent adverse event (TEAE) while on study.	up to 1 year	No