Table 2.
Summary of Naltrexone (NTX) Efficacy and Safety in Adult Trials for Opioid Use
| Reference | Sample Size (Study Design) | Drug: Dosing and Duration | Outcomes |
|---|---|---|---|
| Curran115 | 38 (PCT) | NTX: 6 times a wk for 2 mo, then 3 times a wk for 7 mo | No difference in study completion or treatment effects compared with PLB SAE: none |
| Cornish116 | 51 (PCT) | NTX: 2 times a wk for 6 mo | UDS opioid positive: NTX: 8%; PLB: 30% Probation revoked—return to prison: NTX: 26%; PLB: 56% SAE: none |
| Hollister117 | 192 (PCT) | NTX: 50 mg/day on Monday–Friday and 100 mg/day on Saturday for 8 wk. Then 100 mg on Monday and Wednesday and 150 mg on Friday for 9 mo | Craving score: NTX: −38.0; PLB: −12.9 UDS opioid positive: NTX: 10%; PLB: 33% SAE: none |
| Rawson122 | 132 (PCT) | NTX: 50 mg/day for 2 wk, then 50 mg/day on Monday–Friday and 100 mg on Saturday for 6 wk, then 100 mg on Monday and Wednesday and 150 mg on Friday for 16 wk | UDS opioid positive: NTX: 5.9%; PLB: 28% SAE: none |
| San124 | 50 (PCT) | NTX: 350 mg/wk for up to 1 yr | Treatment completion: NTX: 14.3%; PLB: 36.4% SAE: none |
| Lerner118 | 31 (PCT) | NTX: 350 mg/wk for 2 mo | Opioid free at 1 yr: NTX: 53%; PLB: 38% SAE: none |
| Shufman119 | 32 (PCT) | NTX: 25 mg 2 times a wk for 2 wk, then 50 mg 3 times a wk for 10 wk | Opioid free at 12 wk: NTX: 36%; PLB: 19% Treatment completion: NTX: 50%; PLB: 56% SAE: none |
| Guo128 | 302 (PCT) | NTX: 50 mg/day for 6 mo | Abstinence rate: NTX: 28.6%; PLB: 7.1% SAE: none |
| Krupitsky129 | 52 (PCT) | NTX: 50 mg/day for 6 mo | Relapse rate: NTX: 30%; PLB: 72% Freedom from relapse at 6 mo: NTX: 44%; PLB: 16% SAE: none |
| Krupitsky130 | 280 (PCT) | NTX: 50 mg/day for 6 mo, coadministered with FXT | Relapse rate: NTX + FXT: 30%; NTX: 31%; PLB: 60% SAE: none |
| Stella131 | 56, 4 arms: (PLB, NTX, NTX + PLB, NTX + PZP) | NTX: 50 mg/day ± 10 mg, coadministered PZP for 6 mo | Opioid free at 6 mo: NTX: 43%; NTX + PLB: 43%; NTX + PZM: 86%; PLB: 21% SAE: none |
| Schottenfeld132 | 126 (PCT) | NTX: 350 mg/wk or BPN up to 84 mg/wk or PLB for 24 wk | Freedom from heroin relapse, days (range): BPN: 79 (61–98); NTX: 64 (44–84); PLB: 39 (25–53) SAE: none |
| Krupitsky133 | 250 (PCT) | XR-NTX IM: 380 mg monthly for 24 wk | Abstinent rate (range): XR-NTX: 90% (70%–92%); PLB: 35% (11%–64%) SAE: none |
| Sullivan134 | 60 (ROL) | XR-NTX IM: 380 mg monthly for 24 wk NTX PO: 50 mg/day for 24 wk | Treatment retention rate: XR-NTX: 57%; NTX: 28% SAE: none |
BPN, buprenorphine; FXT, fluoxetine; IM, intramuscular; PCT, placebo-controlled trial; PLB, placebo; PO, orally; PZP, prazepam; ROL, randomized, open label; SAE, serious adverse event; UDS, urine drug screen; XR-NTX, naltrexone intramuscular depot injection