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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04464980 | Optimizing Retention, Duration and Discontinuation Strategies for Opioid Use Disorder Pharmacotherapy (RDD) | PHASE2 | ACTIVE NOT_RECRUITING | 1,516 | — | — | Jun 8, 2021 | Jan 31, 2027 | Dec 15, 2025 | 21 | United States |
Binary (yes/no). Continuously enrolled in maintenance treatment on one or more of the evidence-based MOUD modalities (e.g., SL-BUP, XR-BUP, XR-NTX, or methadone maintenance) with no more than a 28-day gap in MOUD over the 26-week period.
Binary (yes/no). Discontinuing MOUD during the taper period, no return to MOUD, and no relapse to opioid use, either during the taper (up to 48 weeks for those entering on BUP or 24 weeks for those entering on XR-NTX) or during the 24 weeks after MOUD is discontinued.
| Arm | Type | Description |
|---|---|---|
| Retention: SL-BUP standard dose + MM | EXPERIMENTAL | Standard dose sublingual buprenorphine-naloxone (SL-BUP) 16mg/day target plus MM, consisting of standard Medical Management and usual counseling at the treatment program. |
| Retention: SL-BUP high dose + MM | EXPERIMENTAL | High dose sublingual buprenorphine-naloxone (SL-BUP) 32mg/day target plus MM, consisting of standard Medical Management and usual counseling at the treatment program. |
| Retention: XR-BUP + MM | EXPERIMENTAL | Extended-release injectable buprenorphine (XR-BUP) plus MM, consisting of standard Medical Management and usual counseling at the treatment program. |
| Retention: XR-NTX + MM | EXPERIMENTAL | Extended-release injectable naltrexone (XR-NTX) plus MM, consisting of standard Medical Management and usual counseling at the treatment program. |
| Retention: SL-BUP standard dose + MMR | EXPERIMENTAL | Standard dose sublingual buprenorphine-naloxone (SL-BUP) 16mg/day target plus MMR, consisting of Medical Management and usual counseling, plus a technology-based behavioral component. |
| Retention: SL-BUP high dose + MMR | EXPERIMENTAL | High dose sublingual buprenorphine-naloxone (SL-BUP) 32mg/day target plus MMR, consisting of standard Medical Management and usual counseling, plus a technology-based behavioral component. |
| Retention: XR-BUP + MMR | EXPERIMENTAL | Extended-release injectable buprenorphine (XR-BUP) plus MMR, consisting of standard Medical Management and usual counseling, plus a technology-based behavioral component. |
| Retention: XR-NTX + MMR | EXPERIMENTAL | Extended-release injectable naltrexone (XR-NTX) plus MMR, consisting of standard Medical Management and usual counseling, plus a technology-based behavioral component. |
| Discontinuation: Discontinue SL-BUP with SL-BUP + MM | EXPERIMENTAL | Start on SL-BUP, taper with SL-BUP, plus MM, consisting of standard Medical Management and usual counseling at the treatment program. |
| Discontinuation: Discontinue SL-BUP with XR-BUP + MM | EXPERIMENTAL | Start on SL-BUP, taper with XR-BUP, plus MM, consisting of standard Medical Management and usual counseling at the treatment program. |
| Discontinuation: Discontinue XR-BUP with XR-BUP + MM | EXPERIMENTAL | Start on XR-BUP, taper with XR-BUP, plus MM, consisting of standard Medical Management and usual counseling at the treatment program. |
| Discontinuation: Discontinue XR-NTX with XR-NTX + MM | EXPERIMENTAL | Start on XR-NTX, taper with XR-NTX, plus MM, consisting of standard Medical Management and usual counseling at the treatment program. |
| Discontinuation: Discontinue SL-BUP with SL-BUP + MMD | EXPERIMENTAL | Start on SL-BUP, taper with SL-BUP, plus MMD, consisting of standard Medical Management and usual counseling, plus a technology-based behavioral component. |
| Discontinuation: Discontinue SL-BUP with XR-BUP + MMD | EXPERIMENTAL | Start on SL-BUP, taper with XR-BUP, plus MMD, consisting of standard Medical Management and usual counseling, plus a technology-based behavioral component. |
| Discontinuation: Discontinue XR-BUP with XR-BUP + MMD | EXPERIMENTAL | Start on XR-BUP, taper with XR-BUP, plus MMD, consisting of standard Medical Management and usual counseling, plus a technology-based behavioral component. |
| Discontinuation: Discontinue XR-NTX with XR-NTX + MMD | EXPERIMENTAL | Start on XR-NTX, taper with XR-NTX, plus MMD, consisting of standard Medical Management and usual counseling, plus a technology-based behavioral component. |
| Name | Type | Description |
|---|---|---|
| SL-BUP | DRUG | Daily dosing of sublingual buprenorphine-naloxone |
| XR-BUP | DRUG | Weekly/monthly dosing of extended-release injectable buprenorphine |
| XR-NTX | DRUG | Monthly dosing of extended-release injectable naltrexone |
| MM | BEHAVIORAL | MM consists of standard Medical Management and the usual counseling at the treatment program. |
| MMR | BEHAVIORAL | MMR consists of Medical Management and usual counseling, plus a technology-based behavioral component. |
| MMD | BEHAVIORAL | MMD consists of Medical Management and usual counseling, plus a technology-based behavioral component. |
Inclusion Criteria for Retention Phase: 1. 18 years of age or older; 2. Meet DSM-5 criteria for current opioid use disorder (heroin, fentanyl or other synthetic opioids, and/or prescription opioids); 3. Seeking treatment for opioid use disorder and choosing either buprenorphine (BUP) or extended-re...