Table 5.
Summary of Naltrexone (NTX) Efficacy and Safety in Adult Trials for Self-injurious Behavior (SIB)
| Reference | Sample Size (Study Design) | Disease: Dosing and Duration | Outcomes |
|---|---|---|---|
| Sandman153 | 24 (randomized) | SIB – NTX: 0.5, 1, and 2 mg/kg | SIB: − >50% in >50% participants SAE: none |
| Sonne154 | 5 (open-label) | Females with borderline personality disorder – Wk 1: baseline; Wk 2: NTX 50–100 mg/day; Wk 3: post-NTX | YBOCS (modified for SIB): −48% (CV = 48%) SAE: none |
| Willemsen-Swinkels155 | 33 (PCT with crossover) | Adolescents and adults with intellectual disability – NTX: Titrate up to 150 mg/day for 4 wk | Stereotypic behavior: autistic +3% (CV = 47%); non-autistic +35% (37%) Global function: 50 mg +28%; 150 mg +21% SAE: none |
| Sandman156 | 4 (DB, PCT with crossover) | Males – NTX: 0, 25, 50, 100 mg twice weekly for 4 wk | SIB: −50%; No SIB at 100 mg in 75% SAE: none |
| Kars157 | 6 (PCT with crossover) | Males with intellectual disability – NTX: 50 mg/day for 3 wk | SIB: 40% experienced reduction SAE: none |
| Symons158 | 4 PCT with crossover) | Adults with intellectual disability – NTX: 1.5 mg/kg for 2 wk | SIB: reduction of ≥33% in 75% of participants SAE: none |
| Roth159 | 7 (open-label) | Females with SIB – NTX: 50 mg/day | SIB: cessation in 85% of participants SAE: none |
| Zingarelli160 | 8 (PCT with crossover) | Adults with autism – NTX: 50 mg/day for 3 wk | SIB: +22% over baseline SAE: none |
| Symons161 | 4 (PCT with crossover) | Adult males with intellectual disability – NTX: 1.5 mg/kg/day for 10 wk | SIB: −33% to −54% SAE: none |
| Thompson162 | 8 (PCT with crossover) | Adults with intellectual disability – NTX: 50 mg/day and 100 mg/day x for wk | Head-banging: 67%–77% of participants had reduction Self-biting: 100% of participants had reduction SAE: none |
| Sandman109 | 31 (PCT with crossover) | Adults with intellectual disability – NTX: 0.5, 1.0, 2.0 mg/kg/wk | SIB: participants experiencing ≥25% reduction: 0.5 mg/kg: 47.4% ≥1 mg/kg: 52.6% SAE: none |
PCT, placebo-controlled trial; PLB, placebo; SAE, serious adverse event; SIB, self-injurious behavior; YBOCS, Yale-Brown Obsessive Compulsive Scale