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very low dose naltrexone · 1 trial · 1 indication
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 |
|---|---|---|
| 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 |
|---|---|---|
| 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: 1. Men and women 18 to 65 years of age who meet DSM-IV criteria for OD of at least six months duration, supported by a positive urine for opiates and a positive naloxone challenge test if the diagnosis is unclear. 2. Individuals must be capable of giving informed consent and cap...
Very low dose naltrexone is used for opiate dependence, a psychiatric condition. It is being studied as part of a treatment approach for individuals with opioid dependence, specifically in the context of transitioning to a longer-acting injectable formulation.
Very low dose naltrexone is being developed by Alkermes plc, a biopharmaceutical company. Alkermes is listed on the stock exchange under the ticker symbol ALKS.
Very low dose naltrexone is in Phase 2 clinical development. It is an investigational small molecule being studied for the treatment of opiate dependence. It has not been approved by regulatory authorities and remains in clinical testing.
Very low dose naltrexone has one completed clinical trial, identified as NCT01690546. This Phase 2 study, titled "Low Dose Naltrexone-buprenorphine Transfer to Vivitrol Injection in Opioid Dependence," enrolled 38 participants in the United States. The trial was uncontrolled and not randomized or double-blinded.
Very low dose naltrexone is a specific low-dose formulation of naltrexone, an opioid receptor antagonist. In this context, it is being studied as a low-dose adjunct to buprenorphine for opioid dependence, distinct from standard-dose naltrexone used for relapse prevention.