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Naltrexone in young autistic children: a double-blind, placebo-controlled crossover study.
J Am Acad Child Adolesc Psychiatry. 1995 Feb; 34(2):223-31.JA

Abstract

OBJECTIVE

This study evaluated the efficacy and safety of naltrexone, an opiate blocker, in the treatment of autism.

METHOD

Thirteen children with autistic disorder, aged 3.4 to 8.3 years (mean 5.4), were studied in home, school, and outpatient laboratory. Naltrexone, 1.0 mg/kg, was given daily in a randomized, double-blind, placebo-controlled crossover design. Dependent measures included parent and teacher Clinical Global Impressions (CGI), Conners Rating Scales, and Naltrexone Side-Effects (SE) Rating Scale; laboratory CGI, movement actometer readings, and a 10-second interval recording system analysis of on-task, communication initiations, disruptive behavior, and self-stimulation.

RESULTS

Eight of 13 subjects improved in two or more settings. Changes in parent measures (CGI, Conners Impulsivity-Hyperactivity Factor, and SE-Restlessness) and Teacher CGI achieved statistical significance. Teacher SE-Restlessness and initiation of communication in the clinic showed a trend toward improvement. Actometer readings improved in two children who were very active at baseline. Adverse side effects were behavioral, mild, and transient. Administering the bitter tablet was a challenge.

CONCLUSIONS

Naltrexone offers promise as an agent for modest improvement of behavior and social communication in young children with autism. Parent and teacher measures can be useful in outpatient trials to evaluate change.

Authors+Show Affiliations

Child Development Unit, Children's Hospital of Pittsburgh.No affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Research Support, U.S. Gov't, P.H.S.

Language

eng

PubMed ID

7896655

Citation

Kolmen, B K., et al. "Naltrexone in Young Autistic Children: a Double-blind, Placebo-controlled Crossover Study." Journal of the American Academy of Child and Adolescent Psychiatry, vol. 34, no. 2, 1995, pp. 223-31.
Kolmen BK, Feldman HM, Handen BL, et al. Naltrexone in young autistic children: a double-blind, placebo-controlled crossover study. J Am Acad Child Adolesc Psychiatry. 1995;34(2):223-31.
Kolmen, B. K., Feldman, H. M., Handen, B. L., & Janosky, J. E. (1995). Naltrexone in young autistic children: a double-blind, placebo-controlled crossover study. Journal of the American Academy of Child and Adolescent Psychiatry, 34(2), 223-31.
Kolmen BK, et al. Naltrexone in Young Autistic Children: a Double-blind, Placebo-controlled Crossover Study. J Am Acad Child Adolesc Psychiatry. 1995;34(2):223-31. PubMed PMID: 7896655.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Naltrexone in young autistic children: a double-blind, placebo-controlled crossover study. AU - Kolmen,B K, AU - Feldman,H M, AU - Handen,B L, AU - Janosky,J E, PY - 1995/2/1/pubmed PY - 1995/2/1/medline PY - 1995/2/1/entrez SP - 223 EP - 31 JF - Journal of the American Academy of Child and Adolescent Psychiatry JO - J Am Acad Child Adolesc Psychiatry VL - 34 IS - 2 N2 - OBJECTIVE: This study evaluated the efficacy and safety of naltrexone, an opiate blocker, in the treatment of autism. METHOD: Thirteen children with autistic disorder, aged 3.4 to 8.3 years (mean 5.4), were studied in home, school, and outpatient laboratory. Naltrexone, 1.0 mg/kg, was given daily in a randomized, double-blind, placebo-controlled crossover design. Dependent measures included parent and teacher Clinical Global Impressions (CGI), Conners Rating Scales, and Naltrexone Side-Effects (SE) Rating Scale; laboratory CGI, movement actometer readings, and a 10-second interval recording system analysis of on-task, communication initiations, disruptive behavior, and self-stimulation. RESULTS: Eight of 13 subjects improved in two or more settings. Changes in parent measures (CGI, Conners Impulsivity-Hyperactivity Factor, and SE-Restlessness) and Teacher CGI achieved statistical significance. Teacher SE-Restlessness and initiation of communication in the clinic showed a trend toward improvement. Actometer readings improved in two children who were very active at baseline. Adverse side effects were behavioral, mild, and transient. Administering the bitter tablet was a challenge. CONCLUSIONS: Naltrexone offers promise as an agent for modest improvement of behavior and social communication in young children with autism. Parent and teacher measures can be useful in outpatient trials to evaluate change. SN - 0890-8567 UR - https://www.unboundmedicine.com/medline/citation/7896655/Naltrexone_in_young_autistic_children:_a_double_blind_placebo_controlled_crossover_study_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0890-8567(09)63761-8 DB - PRIME DP - Unbound Medicine ER -