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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00981617 | ALK33-005: A Study of ALKS33 (RDC-0313) in Adults With Alcohol Dependence | PHASE2 | COMPLETED | 406 | — | — | Oct 1, 2009 | Aug 1, 2010 | Aug 23, 2011 | 27 | United States |
| Arm | Type | Description |
|---|---|---|
| ALKS33 (RDC-0313) (1 mg) | EXPERIMENTAL | 1 mg ALKS33 (RDC-0313) provided as capsules for daily oral administration |
| ALKS33 (RDC-0313) (2.5 mg) | EXPERIMENTAL | 2.5 mg ALKS33 (RDC-0313) provided as capsules for daily oral administration |
| ALKS33 (RDC-0313) (10 mg) | EXPERIMENTAL | 10 mg ALKS33 (RDC-0313) provided as capsules for daily oral administration |
| Placebo | PLACEBO_COMPARATOR | Matching placebo (capsules without active study drug) provided for daily oral administration |
| Name | Type | Description |
|---|---|---|
| ALKS33 (RDC-0313) (1 mg) | DRUG | 1 mg ALKS33 (RDC-0313) taken once daily for 12 weeks |
| ALKS33 (RDC-0313) (2.5 mg) | DRUG | 2.5 mg ALKS33 (RDC-0313) taken once daily for 12 weeks |
| ALKS33 (RDC-0313) (10 mg) | DRUG | 10 mg ALKS33 (RDC-0313) taken once daily for 12 weeks |
| Placebo | DRUG | Matching placebo taken once daily for 12 weeks |
Inclusion Criteria: * 18 years of age or older * Current diagnosis of alcohol dependence, with recent heavy drinking (eg, 5 drinks per day for men and 4 drinks per day for women) * A noncustodial stable residence and a telephone * Women having reproductive potential must agree to use an approved me...