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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01740414 | Effects of Ibudilast on Oxycodone Self-administration in Opioid Abusers | PHASE2 | COMPLETED | 28 | — | — | Nov 1, 2012 | May 1, 2017 | Aug 17, 2017 | 1 | United States |
Participants are allowed to perform an operant task (click on a mouse) in order to receive a dose drug under investigation (oxycodone dose 0 mg, 15 mg, or 30 mg). The drug breakpoint is the maximum number of responses (mouse clicks) the participant was willing to make to receive the drug. Within the context of abuse liability studies, larger breakpoints represent greater abuse potential of a drug.
| Arm | Type | Description |
|---|---|---|
| MN-166 (formerly AV411) First | ACTIVE_COMPARATOR | Participants who began 14-day maintenance on MN-166 (50 mg) first, before switching to Placebo maintenance. |
| Placebo First | PLACEBO_COMPARATOR | Participants who began 14-day maintenance on Placebo first, before switching to MN-166 (50 mg) maintenance. |
| Name | Type | Description |
|---|---|---|
| MN-166 (50 mg) First | DRUG | In this arm of the study participants were first maintained on 50 mg MN-166 BID for approximately 14 days, and were then switched onto placebo maintenance. The subjective and analgesic effects of Oxycodone (0 mg, 15 mg and 30 mg) were tested under each of the two maintenance conditions (Placebo \& MN-166). |
| Placebo First | DRUG | This arm of the study participants were first maintained on placebo for approximately 14 days, and were then switched onto 50mg MN-166 BID maintenance. . The subjective and analgesic effects of Oxycodone (0 mg, 15 mg and 30 mg) were tested under each of the two maintenance conditions (Placebo \& MN-166). |
Inclusion Criteria: * Adults between the ages of 21 and 55 * Current opioid dependence according to DSM-IV criteria * currently not seeking treatment Exclusion Criteria: * Female patients that are currently pregnant, or breastfeeding. Lack of effective birth control. * Participants who have a pos...