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Naltrexone · 1 trial · 1 indication
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.
| 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. |
| 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. |
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 used for the treatment of opiate dependence, specifically to prevent opioid relapse. It is being studied as an extended-release formulation for this purpose. The drug is administered to help individuals maintain abstinence from opioids after detoxification.
Naltrexone is being developed by Alkermes plc, a biopharmaceutical company. Alkermes is publicly traded under the ticker symbol ALKS on the stock market. The company is conducting clinical trials to evaluate the drug's efficacy in treating opiate dependence.
Naltrexone is currently in Phase 3 clinical development for the treatment of opiate dependence. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The Phase 3 trial has been completed, and the results will inform potential regulatory submissions.
Naltrexone has one completed Phase 3 clinical trial with the identifier NCT01180647. The trial, titled 'Extended-Release Naltrexone for Opioid Relapse Prevention Following Release From Jail,' enrolled 48 participants in the United States. The study was placebo-controlled and randomized, though it was not double-blind.
Naltrexone is being studied in an extended-release formulation, which is designed to provide prolonged drug release. The clinical trial NCT01180647 specifically evaluates extended-release naltrexone for opioid relapse prevention. This formulation may offer advantages over immediate-release versions by reducing dosing frequency.