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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00834080 | ALK21-021: A Safety Study of Medisorb® Naltrexone (VIVITROL®) Administered to Health Care Professionals | PHASE3 | COMPLETED | 38 | — | — | Mar 1, 2009 | May 1, 2012 | Dec 11, 2018 | 11 | United States |
| NCT01218984 | ALK21-004: Single-dose Opiate Challenge of Medisorb® Naltrexone (VIVITROL®) in Adults Who Use Opioids | PHASE2 | COMPLETED | 27 | — | — | Mar 1, 2002 | May 1, 2003 | Jan 11, 2017 | - | — |
A TEAE is any adverse event (AE), whether or not considered drug-related, that develops or worsens in severity after study drug administration begins (ie, from the first administration through the end of the follow-up period).
Photographs of subjects' pupils were measured horizontally and vertically, 15 minutes before the first hydromorphone dose and every 15 minutes after each hydromorphone/placebo for hydromorphone dose, for up to 1 hour. Size was the product of vertical and horizontal measures. The slope, determined by linear regression, was used as a summary measure of the dose-response relationship between the hydromorphone dose and pupil size. The steeper the slope, the greater the hydromorphone effect. A slope of zero indicated no evidence of a hydromorphone effect.
| Arm | Type | Description |
|---|---|---|
| Medisorb naltrexone 380 mg (VIVITROL) | EXPERIMENTAL | - |
| Medisorb naltrexone 75 mg | EXPERIMENTAL | - |
| Medisorb naltrexone 150 mg | EXPERIMENTAL | - |
| Medisorb naltrexone 300 mg | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Medisorb naltrexone 380 mg | DRUG | Intramuscular (IM) injection administered once every 4 weeks for up to 2 years |
| Medisorb naltrexone 75 mg | DRUG | Single administration via intramuscular (IM) injection. |
| Medisorb naltrexone 150 mg | DRUG | Single administration via IM injection. |
| Medisorb naltrexone 300 mg | DRUG | Single administration via IM injection. |
| Hydromorphone (10 mg/mL) | DRUG | Increasing doses of 0, 3, 4.5, and 6 mg were administered at baseline (pre-study drug administration). After study drug administration, additional hydromorphone challenge sessions consisting of administering 0, 3, 4.5, and 6 mg were administered at 1-hr intervals at each of the postdose evaluation visits. In addition, at a randomly selected evaluation visit, subjects received four 0 mg (placebo) doses at 1-hour intervals. |
| Naloxone Challenge and Oral Naltrexone Tolerability Testing | DRUG | Administered according to the instructions provided by the respective manufacturer. Testing occurred at least 7 days after the baseline hydromorphone challenge and prior to study drug administration. |
Primary Inclusion Criteria: * Health care professional (eg, physician, osteopath, nurse, pharmacist) * 18 years of age or older * Enrolled or enrolling in an extended outpatient treatment program for opioid dependence * Women of childbearing potential must agree to use an approved method of contrac...