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Also known as XR-NTX
NTX · 3 trials · 3 indications
The primary objective is to compare outcomes of the three intervention groups, based on self-reports at 6-months post-intervention.
Toleration to the injection was 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).
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. |
| NTX/BUP | EXPERIMENTAL | Oral naltrexone + sublingual buprenorphine |
| NTX/PBO-B | ACTIVE_COMPARATOR | Oral naltrexone + sublingual placebo |
| PBO-N/PBO-B | PLACEBO_COMPARATOR | Oral placebo naltrexone + sublingual placebo buprenorphine |
| 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. |
| NTX/BUP | DRUG | Daily doses |
| NTX/PBO-B | DRUG | Daily doses |
| PBO-N/PBO-B | DRUG | Daily doses |
| 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 being studied for Alcohol Use Disorder and Opioid Use Disorder. It is an investigational small molecule developed by Alkermes plc (ticker: ALKS). Clinical trials have evaluated it in adults with these psychiatric conditions, including a Phase 2 trial in Alcohol Use Disorder and Phase 3 trials in Opioid Use Disorder.
NTX is being developed by Alkermes plc, which trades under the ticker ALKS. The company is responsible for the clinical development of NTX for Alcohol Use Disorder and Opioid Use Disorder.
NTX is in Phase 2 development. It has not been approved by the FDA and remains investigational. The clinical program includes completed trials in both Alcohol Use Disorder and Opioid Use Disorder, with a total of 531 participants enrolled across studies.
NTX has been studied in three completed trials: NCT02537574, a Phase 3 trial in Opioid Use Disorder with 380 participants; NCT02110264, a Phase 3 trial in Opioid Use Disorders with 151 participants; and NCT01932801, a Phase 2 trial in Alcohol Use Disorder with 308 participants. All were conducted in the United States.