Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00501631 | ALK21-014: Efficacy and Safety of Medisorb® Naltrexone (VIVITROL®) After Enforced Abstinence | PHASE3 | COMPLETED | 300 | — | — | Jul 1, 2007 | Mar 1, 2011 | Sep 22, 2011 | - | — |
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).
| Arm | Type | Description |
|---|---|---|
| VIVITROL 380 mg | ACTIVE_COMPARATOR | Administered via intramuscular (IM) injection once every 4 weeks. |
| Placebo for VIVITROL 380 mg | PLACEBO_COMPARATOR | Administered via IM injection once every 4 weeks. |
| Name | Type | Description |
|---|---|---|
| VIVITROL 380 mg | DRUG | Administered via IM injection once every 4 weeks. |
| Placebo for VIVITROL 380 mg | DRUG | Administered via IM injection once every 4 weeks. |
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 fi...