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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01746901 | A Study to Characterize the Abuse Liability of ALO-02 in Healthy, Non-Dependent, Recreational Opioid Abusers | PHASE1 | COMPLETED | 81 | — | — | Feb 1, 2013 | Aug 9, 2013 | Oct 19, 2018 | 1 | Canada |
Drug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 millimeter (mm) bipolar VAS anchored in the center with a neutral anchor of "neither like nor dislike" (score of 50 mm), on the extreme left with "strong disliking" (score of 0 mm) and on the extreme right with "strong liking" (score of 100 mm). Peak Effect (Emax) = Maximum observed score.
Drug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 millimeter (mm) bipolar VAS anchored in the center with a neutral anchor of "neither like nor dislike" (score of 50 mm), on the extreme left with "strong disliking" (score of 0 mm) and on the extreme right with "strong liking" (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hours.
High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score.
High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hours.
| Arm | Type | Description |
|---|---|---|
| Treatment A | PLACEBO_COMPARATOR | - |
| Treatment B | EXPERIMENTAL | - |
| Treatment C | EXPERIMENTAL | - |
| Treatment D | ACTIVE_COMPARATOR | - |
| Treatment E | EXPERIMENTAL | - |
| Treatment F | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Placebo solution + Placebo ALO-02 (intact) |
| intact ALO-02 60 mg/7.2 mg | DRUG | Placebo solution + ALO-02 60 mg/7.2 mg (intact) |
| crushed ALO-02 60 mg/7.2 mg | DRUG | crushed ALO-02 60 mg/7.2 mg in solution + placebo ALO-02 (intact) |
| crushed oxycodone IR 60 mg | DRUG | crushed oxycodone immediate-release (IR) 60 mg in solution + placebo ALO-02 (intact) |
| crushed ALO-02 40 mg/4.8 mg | DRUG | crushed ALO-02 40 mg/4.8 mg in solution + placebo ALO-02 (intact) |
| crushed oxycodone IR 40 mg | DRUG | crushed oxycodone immediate-release (IR) 40 mg in solution + placebo ALO-02 (intact) |
Inclusion Criteria: * Healthy subjects. * Non-dependent, recreational opioid users. (Must use opioid for non-therapeutic purposes on at least 10 occassions within the last year before Screening Visit, and at least once in 8 weeks before the Screening Visit. Exclusion Criteria: * Diagnosis of subs...