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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02537574 | Naltrexone for Use in Conjunction With Buprenorphine in Adults With Opioid Use Disorder Prior to First Dose of VIVITROL® (Naltrexone for Extended-Release Injectable Suspension) | PHASE3 | COMPLETED | 380 | — | — | Aug 1, 2015 | Jan 9, 2017 | Mar 6, 2019 | 20 | United States |
Toleration to the injection was demonstrated by mild opioid withdrawal symptoms (Clinical Opiate Withdrawal Scale \[COWS\] \</=12 or Subjective Opiate Withdrawal Scale \[SOWS\] \</=10) following VIVITROL administration. The COWS is a clinician-rated questionnaire designed to measure 11 common opioid withdrawal signs or symptoms. The summed score provides information about the level of physical dependence on opioids. The range of COWS scores is 0-4 (none to minimal); 5-12 (mild); 13-24 (moderate); 25-36 (moderately severe); and 37-48 (severe withdrawal. The SOWS is a 16-item self-report questionnaire designed to measure the severity of opioid withdrawal symptoms. The subject rates the intensity of symptoms using a 5-point scale. The range of SOWS scores is 1-10 (mild); 11-20 (moderate); and 21-30 (severe).
| Arm | Type | Description |
|---|---|---|
| NTX/BUP | EXPERIMENTAL | Oral naltrexone + sublingual buprenorphine |
| NTX/PBO-B | ACTIVE_COMPARATOR | Oral naltrexone + sublingual placebo |
| PBO-N/PBO-B | PLACEBO_COMPARATOR | Oral placebo naltrexone + sublingual placebo buprenorphine |
| Name | Type | Description |
|---|---|---|
| NTX/BUP | DRUG | Daily doses |
| NTX/PBO-B | DRUG | Daily doses |
| PBO-N/PBO-B | DRUG | Daily doses |
Inclusion Criteria: * Willing and able to provide informed consent * Willing and able to provide government-issued identification * Has a BMI of 18.0-40.0 kg/m\^2 * Has a physiologic dependence on opioids * Is voluntarily seeking treatment for opioid use disorder and willing to completely withdraw ...