Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02110264 | Injectable Pharmacotherapy for Opioid Use Disorders (IPOD) | PHASE3 | COMPLETED | 151 | — | — | Jun 1, 2015 | May 1, 2019 | Jan 22, 2020 | 1 | United States |
The primary objective is to compare outcomes of the three intervention groups, based on self-reports at 6-months post-intervention.
| 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. |
| 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. |
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...