title: Low-dose naltrexone effects on plasma chemistries and clinical symptoms in autism: a double-blind, placebo-controlled study.
abstract: The effect of month-long naltrexone (NTX) treatment at a daily oral dose of 0.5 mg/kg/day was contrasted with placebo (PLC) in a double-blind study with conjoint clinical and biochemical evaluations of therapeutic effects. Modest clinical benefits were achieved with both PLC and NTX, with marginally better overall results following NTX, and degree of improvement appeared to be related to plasma chemical profiles. Massively elevated levels of beta-endorphin were observed in all children with assays using C-terminal antibody but not with an N-terminal antibody assay. In addition, 70% of the children exhibited abnormally low levels of adrenocorticotropic hormone, and smaller subsets exhibited elevated norepinephrine (60%), arginine-vasopressin (50%), and serotonin (20%). The best clinical responders exhibited the clearest normalization of the elevated plasma chemistries, especially in C-terminal-beta-endorphin and serotonin. There was some evidence of therapeutic carry-over effects in both clinical and biochemical measures in those children who received NTX before PLC. The results suggest that NTX only benefits a subgroup of autistic children, who may be identified by the presence of certain plasma abnormalities. These results suggest a possible linkage between abnormal plasma chemistries, especially those related to the pro-opiomelanocortin system, and autistic symptoms.
authors.affiliation: Service de Psychopathologie de l'Enfant et de l'Adolescent, Hôpital Robert Debré, Paris, France.
authors.forename: M P
authors.initials: MP
authors.lastname: Bouvard
authors.forename: M
authors.initials: M
authors.lastname: Leboyer
authors.forename: J M
authors.initials: JM
authors.lastname: Launay
authors.forename: C
authors.initials: C
authors.lastname: Recasens
authors.forename: M H
authors.initials: MH
authors.lastname: Plumet
authors.forename: D
authors.initials: D
authors.lastname: Waller-Perotte
authors.forename: F
authors.initials: F
authors.lastname: Tabuteau
authors.forename: D
authors.initials: D
authors.lastname: Bondoux
authors.forename: M
authors.initials: M
authors.lastname: Dugas
authors.forename: P
authors.initials: P
authors.lastname: Lensing
mesh_terms: D000293:Adolescent; D001321:Autistic Disorder / Q000097:blood / Q000188:drug therapy* / Q000523:psychology; D002648:Child; D002675:Child, Preschool; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008297:Male; D009271:Naltrexone / Q000008:administration & dosage* / Q000009:adverse effects; D009292:Narcotic Antagonists / Q000008:administration & dosage* / Q000009:adverse effects; D018377:Neurotransmitter Agents / Q000097:blood*; D010552:Personality Assessment; D001615:beta-Endorphin / Q000097:blood*
chemical_list: D009292:Narcotic Antagonists; D018377:Neurotransmitter Agents; D009271:Naltrexone; D001615:beta-Endorphin