Back to resultsALK21-014: Efficacy and Safety of Medisorb® Naltrexone (VIVITROL®) After Enforced Abstinence
Primary Purpose
Alcohol Dependence
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
VIVITROL 380 mg
Placebo for VIVITROL 380 mg
Sponsored by
About this trial
This is an interventional treatment trial for Alcohol Dependence focused on measuring Addiction, Alcoholism, Inpatient detoxification
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
VIVITROL 380 mg
Placebo for VIVITROL 380 mg
Arm Description
Administered via intramuscular (IM) injection once every 4 weeks.
Administered via IM injection once every 4 weeks.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Longer-term Safety of VIVITROL
Number of subjects reporting at least 1 treatment-emergent adverse event (TEAE) while on study.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00501631
Brief Title
ALK21-014: Efficacy and Safety of Medisorb® Naltrexone (VIVITROL®) After Enforced Abstinence
Official Title
Efficacy and Safety of VIVITROL® in Adults Completing Inpatient Treatment for Alcohol Dependence
Study Type
Interventional
2. Study Status
Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
March 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alkermes, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Dependence
Keywords
Addiction, Alcoholism, Inpatient detoxification
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
300 (Actual)
8. Arms, Groups, and Interventions
Arm Title
VIVITROL 380 mg
Arm Type
Active Comparator
Arm Description
Administered via intramuscular (IM) injection once every 4 weeks.
Arm Title
Placebo for VIVITROL 380 mg
Arm Type
Placebo Comparator
Arm Description
Administered via IM injection once every 4 weeks.
Intervention Type
Drug
Intervention Name(s)
VIVITROL 380 mg
Other Intervention Name(s)
naltrexone for extended-release injectable suspension, Medisorb naltrexone
Intervention Description
Administered via IM injection once every 4 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo for VIVITROL 380 mg
Intervention Description
Administered via IM injection once every 4 weeks.
Primary Outcome Measure Information:
Title
Cumulative Percentage of Participants by Heavy Drinking Rate
Description
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).
Time Frame
up to 12 weeks
Secondary Outcome Measure Information:
Title
Longer-term Safety of VIVITROL
Description
Number of subjects reporting at least 1 treatment-emergent adverse event (TEAE) while on study.
Time Frame
up to 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bernard L. Silverman, MD
Organizational Affiliation
Alkermes, Inc.
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
ALK21-014: Efficacy and Safety of Medisorb® Naltrexone (VIVITROL®) After Enforced Abstinence
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