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document
Naltrexone plasma levels , clinical response and effect on weight in autistic children . This research measured naltrexone levels in plasma , to assess the relationship between behavioral response to naltrexone and plasma levels , and the effects of naltrexone on weight in hospitalized autistic children ( n = 41 ) . A double-blind , placebo-controlled , parallel groups design with fixed dose was used , with random assignment to naltrexone or placebo . Drug plasma levels were analyzed by gas chromatography/mass spectrometry , and weights were obtained weekly . Naltrexone levels measured in 17 children ranged from 0.12 to 5.60 ng/mL ( mean = 0.71 , standard error of the mean = 0.32 ) . There was no relationship between plasma levels and age , level of intellectual functioning , scores on the 14 selected Children 's Psychiatric Rating Scale ( CPRS ) items , Clinical Global Impressions , Global Clinical Consensus , and the CPRS hyperactivity factor . There was a trend ( p = .06 ) for children receiving naltrexone in the highest weight percentile ( > or = 90th ) to lose weight ( mean = -0.42 kg ) but this was not the case for those in the lower weight percentiles ( mean = +0.03 kg ) .
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Intervention_Pharmacological
Naltrexone
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Intervention_Pharmacological
naltrexone
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Intervention_Pharmacological
naltrexone
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Intervention_Pharmacological
naltrexone
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Intervention_Control
placebo-controlled
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Intervention_Control
placebo
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Intervention_Physical
gas chromatography/mass spectrometry
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Intervention_Psychological
, and
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Intervention_Physical
weights were obtained weekly
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Intervention_Pharmacological
Naltrexone
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Outcome_Physical
Drug plasma levels
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Outcome_Mental
Children 's Psychiatric Rating Scale ( CPRS ) items , Clinical Global Impressions , Global Clinical Consensus , and the CPRS hyperactivity factor .
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Participant_Condition
autistic children .
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Participant_Condition
hospitalized autistic children ( n = 41 ) .
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Participant_Sample-size
17
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Participant_Age
children
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Participant_Sample-size
14 selected