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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01846481 | A Randomized, 4-sequence, 2-period, Double-blind, Placebo Controlled Study With a DSM-IV-TR Diagnosis of Cocaine Abuse | PHASE2 | COMPLETED | 40 | — | — | Apr 1, 2013 | Jun 1, 2013 | Sep 23, 2016 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| RBP-8000 100mg/Placebo | EXPERIMENTAL | Day 1: 50mg intravenous infusion of cocaine Day 3: 50mg intravenous infusion of cocaine followed by a 100mg intravenous infusion of RBP-8000 Day 6: 50mg intravenous infusion of cocaine followed by an intravenous infusion of placebo |
| Placebo/RBP-8000 100mg | EXPERIMENTAL | Day 1: 50mg intravenous infusion of cocaine Day 3: 50mg intravenous infusion of cocaine followed by an intravenous infusion of placebo Day 6: 50mg intravenous infusion of cocaine followed by a 100mg intravenous infusion of RBP-8000 |
| RBP-8000 200mg/Placebo | EXPERIMENTAL | Day 1: 50mg intravenous infusion of cocaine Day 3: 50mg intravenous infusion of cocaine followed by a 200mg intravenous infusion of RBP-8000 Day 6: 50mg intravenous infusion of cocaine followed by an intravenous infusion of placebo |
| Placebo/RBP-8000 200mg | EXPERIMENTAL | Day 1: 50mg intravenous infusion of cocaine Day 3: 50mg intravenous infusion of cocaine followed by an intravenous infusion of placebo Day 6: 50mg intravenous infusion of cocaine followed by a 200mg intravenous infusion of RBP-8000 |
| Name | Type | Description |
|---|---|---|
| RBP-8000 100 mg | DRUG | RBP-8000 100 mg administered in the vein on either study day 3 or 6. There is a 72-hour washout between Days 3 and 6 |
| Placebo | DRUG | IV infusion of Placebo administered 1 minute after cocaine infusion on either day 3 or 6. |
| Cocaine | DRUG | 50 mg intravenous (IV) dose of cocaine administered over 10 minutes on Days 1, 3 and 6. |
| RBP-8000 200 mg | DRUG | RBP-8000 200 mg administered in the vein on either study day 3 or 6. There is a 72-hour washout between Days 3 and 6 |
Inclusion Criteria: * Male and female volunteers aged 21-50 years, inclusive * Body mass index (BMI)18-32 kg/m\^2 and weight of at least 50 kg * Not currently seeking treatment for substance abuse or substance dependence * Subject is healthy, in the opinion of the Principal Investigator other than ...