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NTX · 2 trials · 2 indications
The primary objective is to compare outcomes of the three intervention groups, based on self-reports at 6-months post-intervention.
Using the Alcohol Quantity and Use Assessment, we will collect data on peak alcohol quantity.
Using the Short Inventory of Problems, we collected data on alcohol-related harm in the past month. The range of possible scores on the single summary score is 0-45, and higher scores indicate a greater experience of alcohol-related harm.
Addiction Severity Index (ASI - 5th edition) will be used to assess frequency of alcohol use in the past 30 days.
| Arm | Type | Description |
|---|---|---|
| Vivitrol (XR-NTX) | EXPERIMENTAL | 50 participants will be randomized to the long-acting naltrexone condition (XR-NTX) which will include monthly injections of study drug. |
| XR-NTX+PN | EXPERIMENTAL | 50 participants will be randomized to receive long-acting naltrexone (XR-NTX) and will be assigned to a patient navigator (PN). |
| ETAU | ACTIVE_COMPARATOR | 50 participants will be randomized to the drug-education/treatment-as-usual group. |
| Assessment-only | NO_INTERVENTION | Assessment-only control condition |
| HRC | ACTIVE_COMPARATOR | Harm reduction counseling, which entails provision of feedback and support of harm reduction goals and safer drinking provided at one-month intervals over a 3-month period. |
| XR-NTX+HRC | EXPERIMENTAL | 3 doses of active medication (380 mg injection/month) + Harm reduction counseling at one-month intervals over three months. |
| Placebo+HRC | PLACEBO_COMPARATOR | 3 doses of placebo + harm reduction counseling at one-month intervals over a three-month period |
| Name | Type | Description |
|---|---|---|
| XR-NTX | DRUG | Monthly injections of XR-NTX will be administered to participants assigned to either the XR-NTX or XR-NTX+PN groups. |
| XR-NTX+PN | BEHAVIORAL | In addition to long-acting naltrexone (XR-NTX), participants assigned to the XR-NTX+PN condition will meet regularly with a patient navigator to assist in accessing psychosocial services when released from jail. |
| ETAU | BEHAVIORAL | Participants assigned to the ETAU group will receive drug education. |
| Placebo | OTHER | - |
| HRC | BEHAVIORAL | - |
Inclusion Criteria: 1. Be at least 18 years of age or older, 2. Meet criteria for DSM-5 opioid use disorders, 3. Be detained for at least 48 hours, 4. Have an expected release date within one year, 5. Plan to reside in area after release. Exclusion Criteria: 1. Have a medical (e.g., liver failure...
NTX is an investigational small molecule being developed for Alcohol Use Disorder and Opioid Use Disorder. It is studied as a pharmacotherapy to support harm reduction and treatment in these psychiatric conditions. The drug is in clinical development and has not been approved by the FDA.
NTX is being developed by Alkermes plc, a biopharmaceutical company traded on the NASDAQ under the ticker symbol ALKS. Alkermes is conducting clinical trials to evaluate NTX for the treatment of Alcohol Use Disorder and Opioid Use Disorder.
NTX is in Phase 2 and Phase 3 clinical development. One completed Phase 2 trial evaluated NTX for Alcohol Use Disorder, and two completed Phase 3 trials assessed it for Opioid Use Disorder. The drug remains investigational and is not yet approved.
NTX has been studied in three completed clinical trials. NCT01932801 was a Phase 2 trial for Alcohol Use Disorder with 308 participants. NCT02110264 and NCT02537574 were Phase 3 trials for Opioid Use Disorder, with 151 and 380 participants respectively. All trials were conducted in the United States.
NTX is a form of naltrexone, an opioid antagonist. One trial, NCT02537574, evaluated naltrexone for use with buprenorphine in adults with Opioid Use Disorder prior to the first dose of VIVITROL, which is naltrexone for extended-release injectable suspension. NTX is being developed by Alkermes.