. 2021 Sep 24;26(7):675–695. doi: 10.5863/1551-6776-26.7.675

Table 8.

Summary of Naltrexone (NTX) Efficacy and Safety in Pediatric Trials Involving Substance and Sexual Addiction.

Reference	Sample Size (Study Design)	Dosing and Duration	Outcome
Miranda¹⁷⁹	22 (PCT with crossover)	15- to 19-yr–old adolescents with problem drinking – NTX: 50 mg/day for 8–10 days	Drinking days: NTX: 2.4 (CV = 58%); PLB: 3.1 Heavy drinking days: NTX: 1.1 (CV = 90%); PLB: 1.6 SAE: none
Deas¹⁹	5 (open-label)	Treatment-seeking adolescents with alcohol dependence – NTX: 50 mg/day up to 6 wk	Drinks per drinking days compared with baseline: −7.61 (CV = 13%) SAE: none
Hulse¹⁸⁰	8 (retrospectivecase series)	15- to 19-yr–old opioid dependent – NTX: 50 mg/day oral followed by NTX implant	Opioid overdose/yr: Implant: 0.19 (SE = 0.13); Oral: 1.9 (SE = 0.74) Baseline: 8.9 SAE: none
Fishman¹⁸¹	16 (Retrospective case series)	Opioid-dependent adolescents and young adults – NTX: implant	Retained in treatment ≥4 mo: 63% “good” outcome defined as substantially decreased opioid use: 56% SAE: none
Ryback¹⁸³	21 (open-label)	13- to 17-yr adolescents with sexual addiction – NTX: up to 200 mg/day for an average of 12 months (range 4.5–21 months)	Responders: 71% Relapse: occurred in n=13 when NTX tapered ≤50 mg/day

CV, coefficient of variation; PCT, placebo-controlled trial; PLB, placebo; SAE, serious adverse event