82906
document
Naltrexone in young autistic children : a double-blind , placebo-controlled crossover study . 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 .
82907
Intervention_Pharmacological
Naltrexone
82908
Intervention_Control
placebo-controlled
82909
Intervention_Pharmacological
naltrexone
82910
Intervention_Pharmacological
Naltrexone , 1.0 mg/kg
82911
Intervention_Physical
placebo-controlled crossover design
82912
Intervention_Educational
communication initiations
82913
Intervention_Other
,
82914
Intervention_Educational
disruptive behavior ,
82915
Intervention_Other
and
82916
Intervention_Educational
self-stimulation
82917
Intervention_Pharmacological
Naltrexone
82918
Outcome_Other
efficacy and safety
82919
Outcome_Mental
Clinical Global Impressions ( CGI )
82920
Outcome_Mental
Conners Rating Scales
82921
Outcome_Other
Naltrexone Side-Effects ( SE ) Rating Scale
82922
Outcome_Mental
laboratory CGI
82923
Outcome_Mental
movement actometer readings
82924
Outcome_Mental
a 10-second interval recording system analysis of on-task
82925
Outcome_Mental
communication initiations
82926
Outcome_Mental
disruptive behavior
82927
Outcome_Mental
self-stimulation
82928
Outcome_Mental
parent measures ( CGI
82929
Outcome_Mental
Conners Impulsivity-Hyperactivity Factor
82930
Outcome_Mental
SE-Restlessness
82931
Outcome_Mental
Teacher CGI
82932
Outcome_Mental
Teacher SE-Restlessness
82933
Outcome_Mental
initiation of communication
82934
Outcome_Physical
Actometer readings
82935
Outcome_Adverse-effects
Adverse side effects
82936
Outcome_Mental
social communication
82937
Participant_Age
young
82938
Participant_Condition
autistic children
82939
Participant_Condition
autism .
82940
Participant_Sample-size
Thirteen
82941
Participant_Condition
autistic disorder
82942
Participant_Age
aged 3.4 to 8.3 years
82943
Participant_Age
young children
82944
Participant_Condition
autism