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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alkermes
ClinicalTrials.gov Identifier:
NCT00501631
First received: July 12, 2007
Last updated: September 20, 2011
Last verified: September 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Alcohol Dependence
 Drug: VIVITROL 380 mg
Drug: Placebo for VIVITROL 380 mg
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of VIVITROL® in Adults Completing Inpatient Treatment for Alcohol Dependence

Resource links provided by NLM:

MedlinePlus related topics: Alcoholism
U.S. FDA Resources

Further study details as provided by Alkermes:

Primary Outcome Measures:
  • Cumulative Percentage of Participants by Heavy Drinking Rate [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
    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:
  • Longer-term Safety of VIVITROL [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]
    Number of subjects reporting at least 1 treatment-emergent adverse event (TEAE) while on study.


Enrollment: 300
Study Start Date: July 2007
Study Completion Date: March 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00501631

Sponsors and Collaborators
Alkermes
Investigators
Study Director: Bernard L. Silverman, MD Alkermes
  More Information

No publications provided

Responsible Party: Alkermes
ClinicalTrials.gov Identifier: NCT00501631     History of Changes
Other Study ID Numbers: ALK21-014
Study First Received: July 12, 2007
Results First Received: March 23, 2011
Last Updated: September 20, 2011
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices
Austria: Federal Office for Safety in Health Care

Keywords provided by Alkermes:
Addiction
Alcoholism
Inpatient detoxification

Additional relevant MeSH terms:
Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Mental Disorders
Naltrexone
Narcotic Antagonists
 Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013