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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00382642 | Pharmacological Treatment for Alcoholism | PHASE3 | COMPLETED | 283 | — | — | Jun 1, 2006 | Dec 1, 2009 | Feb 7, 2012 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| Ondansetron | EXPERIMENTAL | Arm 1 = Ondansetron 4 mcg/kg b.i.d.+ Cognitive behavioral therapy |
| Placebo | PLACEBO_COMPARATOR | Arm 2 = Placebo + Cognitive behavioral therapy |
| Name | Type | Description |
|---|---|---|
| Ondansetron + Cognitive Behavioral Therapy | DRUG | 13 week outpatient trial |
| Placebo + Cognitive Behavioral Therapy | DRUG | 13 week outpatient trial |
Inclusion Criteria: * Males and females who have given written informed consent. * Ages 18 years and above and, must weigh at least 40 Kg and no more than 140 Kg * Good physical health as determined by a complete physical examination, an EKG within normal limits, and laboratory screening tests with...