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Naltrexone · 3 trials · 2 indications
Post-release opioid relapse at week 4, measured by self-report (Time Line Follow Back) and urine toxicologies, and defined as ≥10 of 28 days of self-reported opioid misuse following jail release or two or three positive of the three urine samples during weeks 2, 3 and 4. A single positive or missing urine result counted as 7 opioid misuse days.
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).
After the initial titration period for opioid withdrawal (of up to 8 days), patients will receive the Vivitrol injection. Then, we will follow patients for retention out to 4 weeks.
| Arm | Type | Description |
|---|---|---|
| Extended-release naltrexone (XR-NTX) | ACTIVE_COMPARATOR | A single 380mg IM depot injection of XR-NTX in the week prior to release from jail. A second 380mg IM injection is offered to persons in the XR-NTX arm post-release and 4 weeks after the initial injection. |
| Motivational Enhancement Counseling Only | PLACEBO_COMPARATOR | The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail. |
| PBO NTX + BUP | ACTIVE_COMPARATOR | Placebo naltrexone + buprenorphine |
| NTX + BUP | EXPERIMENTAL | Naltrexone + buprenorphine |
| BUP/VLNXT to VIVITROL | EXPERIMENTAL | On days 1-3, participants will receive buprenorphine/naloxone daily, starting at a dose of 4 mg, progressively decreasing to 2 mg on Days 2-3 and very low dose naltrexone at 0.25 mg to 1 mg on Days 1-3, 2 to 6 mg on Day 4 and 10 mg to 50 mg on Days 5-7. VIVITROL injection will be administered on Day 8 at 380 mg. |
| Name | Type | Description |
|---|---|---|
| Extended-Release Naltrexone | DRUG | 380mg IM XR-NTX injection one week prior to release from jail; a second XR-NTX 380mg IM injection is offered 4 weeks later (monthly). |
| Motivational Enhancement Counseling | BEHAVIORAL | The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail. |
| Naltrexone | DRUG | daily dosing |
| Placebo | DRUG | daily dosing |
| Buprenorphine | DRUG | daily dosing |
| very low dose naltrexone | DRUG | On days 1-3, participants will receive buprenorphine/naloxone daily, starting at a dose of 4 mg, progressively decreasing to 2 mg on Days 2-3 and very low dose naltrexone at 0.25 mg to 1 mg on Days 1-3, 2 to 6 mg on Day 4 and 10 mg to 50 mg on Days 5-7. VIVITROL injection will be administered on Day 8 at 380 mg. |
| extended release naltrexone | DRUG | On days 1-3, participants will receive buprenorphine/naloxone daily, starting at a dose of 4 mg, progressively decreasing to 2 mg on Days 2-3 and very low dose naltrexone at 0.25 mg to 1 mg on Days 1-3, 2 to 6 mg on Day 4 and 10 mg to 50 mg on Days 5-7. VIVITROL injection will be administered on Day 8 at 380 mg. |
| buprenorphine/naloxone | DRUG | On days 1-3, participants will receive buprenorphine/naloxone daily, starting at a dose of 4 mg, progressively decreasing to 2 mg on Days 2-3 and very low dose naltrexone at 0.25 mg to 1 mg on Days 1-3, 2 to 6 mg on Day 4 and 10 mg to 50 mg on Days 5-7. VIVITROL injection will be administered on Day 8 at 380 mg. |
Inclusion Criteria: * Adults incarcerated in NYC jails with known release date * DSM-IV criteria for current opioid dependence * No current agonist (methadone, buprenorphine) treatment * Currently opioid free by history ('detoxed') and with a negative urine for all opioids * General good health as ...
Naltrexone is a small molecule studied for opioid use disorder, a condition in which people struggle to stop using opioids. It has been evaluated in a Phase 3 trial in adults transitioning from buprenorphine maintenance before a first dose of VIVITROL. It is investigational in this setting and is not described as approved for this use.
Alkermes plc, which trades under the ticker ALKS, is the developer associated with naltrexone in this program. The company is listed as the sponsor of the Phase 3 study evaluating naltrexone in adults with opioid use disorder.
Naltrexone is in Phase 3 development for opioid use disorder. One Phase 3 trial has been completed, and no trials are currently active. Because the program remains in clinical development, naltrexone is investigational and is not described as FDA approved for this indication.
Naltrexone has been studied in one completed Phase 3 trial, NCT02696434, titled Evaluating Naltrexone for Use in Conjunction With Buprenorphine in Adults With Opioid Use Disorder Transitioning From Buprenorphine Maintenance Prior to First Dose of VIVITROL. The trial enrolled 101 participants in the United States, was randomized, double blind, and active controlled, and included adults 18 years and older.
Yes, oral naltrexone 50 mg is another name for naltrexone. People searching for oral naltrexone 50 mg are looking at the same drug asset, which is being evaluated in opioid use disorder.