OBJECTIVE: To assess critically the short-term efficacy and safety of naltrexone in autistic children and its effects on discrimination learning in the laboratory. METHOD: A parallel group design was employed. After a 2-week placebo baseline period, children were randomly assigned either to naltrexone or to placebo for a period of 3 weeks followed by a one-week posttreatment placebo period. Multiple raters and rating scales were employed in a variety of conditions. Forty-one children, all inpatients, ages 2.9 to 7.8 years, completed the study. Naltrexone reduced hyperactivity and had no effect on discrimination learning in the laboratory. There was a suggestion that it had a beneficial effect on decreasing self-injurious behavior. Untoward effects were mild and transient. CONCLUSION: In the present study, naltrexone significantly reduced only hyperactivity, and no serious untoward effects were observed. The effectiveness of naltrexone in the treatment of autism and self-injurious behavior requires additional assessment in a sample of children with moderate to severe self-injurious behavior.
RCT Entities:
OBJECTIVE: To assess critically the short-term efficacy and safety of naltrexone in autisticchildren and its effects on discrimination learning in the laboratory. METHOD: A parallel group design was employed. After a 2-week placebo baseline period, children were randomly assigned either to naltrexone or to placebo for a period of 3 weeks followed by a one-week posttreatment placebo period. Multiple raters and rating scales were employed in a variety of conditions. Forty-one children, all inpatients, ages 2.9 to 7.8 years, completed the study. Naltrexone reduced hyperactivity and had no effect on discrimination learning in the laboratory. There was a suggestion that it had a beneficial effect on decreasing self-injurious behavior. Untoward effects were mild and transient. CONCLUSION: In the present study, naltrexone significantly reduced only hyperactivity, and no serious untoward effects were observed. The effectiveness of naltrexone in the treatment of autism and self-injurious behavior requires additional assessment in a sample of children with moderate to severe self-injurious behavior.
Authors: L E Arnold; M G Aman; A Martin; A Collier-Crespin; B Vitiello; E Tierney; R Asarnow; F Bell-Bradshaw; B J Freeman; P Gates-Ulanet; A Klin; J T McCracken; C J McDougle; J J McGough; D J Posey; L Scahill; N B Swiezy; L Ritz; F Volkmar Journal: J Autism Dev Disord Date: 2000-04
Authors: Emma G Duerden; Hannah K Oatley; Kathleen M Mak-Fan; Patricia A McGrath; Margot J Taylor; Peter Szatmari; S Wendy Roberts Journal: J Autism Dev Disord Date: 2012-11