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Label indication Treatment with naltrexone for extended-release injectable suspension should be part of a comprehensive management program that includes psychosocial support. Naltrexone for extended-release injectable suspension contains naltrexone, an opioid antagonist, and is indicated for the treatment of alcohol dependence in patients who are able to abstain from alcohol in an outpatient setting prior to initiation of treatment… FDA label
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 antagonist studied for opioid use disorder. Alkermes plc is developing oral naltrexone 50 mg in Phase 3. It is designed to block opioid receptors and reduce the rewarding effects of opioids, supporting abstinence in adults with opioid use disorder.
Naltrexone targets the opioid receptors OPRK1, OPRD1, and OPRM1 as an antagonist. By blocking these receptors, it prevents opioids from producing their effects. This mechanism underlies its investigation for opioid use disorder.
Alkermes plc (ticker: ALKS) is developing oral naltrexone 50 mg for opioid use disorder. The company is responsible for its clinical development.
Naltrexone is in Phase 3 development for opioid use disorder. It is investigational and has not been approved by the FDA for this indication. The Phase 3 trial has been completed.
Naltrexone has been studied in a 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." It enrolled 101 adults in the United States and was randomized, double-blind, and active-controlled.