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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01030406 | Study of the Relative Abuse Potential of Acurox Tablets in Non-Dependent Recreational Opioid Users | PHASE2 | COMPLETED | 49 | — | — | Jan 1, 2010 | Feb 1, 2010 | Nov 1, 2018 | 1 | United States |
Drug Liking/Disliking Assessment on a 101 point bipolar visual analog scale (VAS) used to assess response to the question "Do you dislike or like the drug effect you are feeling now?" and anchored in the center with "Neither like nor dislike" (score of 50), on the left with "Dislike an awful lot" (score of 0) and on the right with "Like an awful lot" (score of 100).
| Arm | Type | Description |
|---|---|---|
| 40/0mg taken first | ACTIVE_COMPARATOR | 8x oxycodone/niacin 5/0mg tablets |
| 80/0mg taken first | ACTIVE_COMPARATOR | 8x oxycodone/niacin 10/0mg tablets |
| 40/240mg taken first | EXPERIMENTAL | 8x oxycodone/niacin 5/30mg tablets |
| 80/480mg taken first | EXPERIMENTAL | 8x oxycodone/niacin 10/60mg tablets |
| 0/0mg taken first | PLACEBO_COMPARATOR | Placebo |
| Name | Type | Description |
|---|---|---|
| 40/0mg taken first | DRUG | 8x Oxycodone/Niacin 5/0mg tablets All arms taken with a 48 hour washout between doses |
| 80/0mg taken first | DRUG | 8x Oxycodone/Niacin 10/0mg tablets All arms taken with a 48 hour washout between doses |
| 40/240mg taken first | DRUG | 8x Oxycodone/Niacin 5/30mg tablets All arms taken with a 48 hour washout between doses |
| 80/480mg taken first | DRUG | 8x Oxycodone/Niacin 10/60mg tablets All arms taken with a 48 hour washout between doses |
| 0/0mg taken first | DRUG | Placebo All arms taken with a 48 hour washout between doses |
Inclusion Criteria: * Subject is male or female between 18 and 55 years old. * Subject is in generally good health, including no history of pulmonary disease, and has a body mass index (BMI) within 18-33 kg/m2. * Subject is a recreational opioid user (i.e., at least 10 occasions within the past 12 ...