Conditioned placebo dose reduction: a new treatment in attention-deficit hyperactivity disorder?
OBJECTIVE
This study examined if pairing a placebo with stimulant medication produces a placebo response that allows children with attention-deficit hyperactivity disorder (ADHD) to be maintained on a lower dose of stimulant medication. The primary aim was to determine the efficacy, side effects, and acceptability of a novel conditioned placebo dose reduction procedure.


METHODS
Participants included 99 children ages 6 to 12 years with ADHD. After an initial double-blind dose finding to identify optimal dose of mixed amphetamine salts, subjects were randomly assigned to 1 of 3 treatments of 8-week duration: (a) conditioned placebo dose reduction condition (50% reduced dose/placebo [RD/P]) or (b) a dose reduction only condition (RD) or (c) a no reduction condition (full dose). The innovative conditioned placebo dose reduction procedure involved daily pairing of mixed amphetamine salts dose with a visually distinctive placebo capsule administered in open label, with full disclosure of placebo use to subjects and parents.


RESULTS
Seventy children completed the study. There were no differences in subject retention among the 3 groups. Most subjects in the RD/P group remained stable during the treatment phase, whereas most in the RD group deteriorated. There was no difference in control of ADHD symptoms between the RD/P group and the full dose group, and both RD/P and full dose groups showed better ADHD control than the RD group. Treatment emergent side effects were lowest in the RD/P group.


CONCLUSIONS
Pairing placebos with stimulant medication elicits a placebo response that allows children with ADHD to be effectively treated on 50% of their optimal stimulant dose.
Sandler
Adrian D
AD
Olson Huff Center, Mission Children's Hospital, Asheville, NC 28803, USA. adsandler@pol.net
Glesne
Corrine E
CE
Bodfish
James W
JW
D000662:Amphetamines / Q000008:administration & dosage* / Q000627:therapeutic use; D001289:Attention Deficit Disorder with Hyperactivity / Q000188:drug therapy*; D000697:Central Nervous System Stimulants / Q000008:administration & dosage* / Q000627:therapeutic use; D002648:Child; D018592:Cross-Over Studies; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D008297:Male; D015990:Placebo Effect; D010919:Placebos / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome
D000662:Amphetamines; D000697:Central Nervous System Stimulants; D010919:Placebos