Clinical trial NCT00573534
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: Attention Deficit Hyperactivity Disorder ADHD ADD Prevention Substance use Adolescent
Sponsor: New York State Psychiatric Institute
Start date: 2008-03-01; Completion date: 2010-03-01
Enrollment: 8 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is an open label pilot study to obtain information on the best way to study young adolescents with Attention Deficit Hyperactivity Disorder (ADHD)who may also be at risk of developing substance abuse, in part because of their ADHD. The plan is to recruit older children/young adolescents (age 11-15) who have ADHD and also have an older sibling with substance abuse. The treatment for ADHD in the 11-15 year old will be Vyvanse, a novel preparation of dextroamphetamine in which the molecule is inactivated and only becomes activated when it is digested. This preparation is felt to be safer from diversion while at the same time providing treatment for the younger siblings in which a bad outcome has already occurred in the family, namely the older sibling's substance abuse. As mentioned, this is an open-label study, a feasibility study to see if we can use this approach to study and treat high risk youth before they develop substance abuse.

Detailed description:
The study is a six month open-label treatment with Vyvanse, a novel preparation of the Attention Deficit Hyperactivity Disorder (ADHD) medication dextroamphetamine in which the drug is inactivated and only becomes reactivated when digested. Vyvanse is thought to be safer in youth at risk for substance use disorder because it is harder to abuse and divert. It is FDA approved to treat ADHD in children age 6 through 12. Although there are no negative studies in adolescents 13-15, efficacy has not been established in the latter age group.

In this study 30 adolescents (ages 11-15) will be identified who have Attention Deficit Disorder and are at risk for alcohol and substance use problems. We propose to treat their Attention Deficit Hyperactivity Disorder with Vyvanse in the hope that it may prevent ADHD from promoting the development of alcohol and substance abuse problems. Our main goal is to see if we can identify children who are at risk because they have an older sibling who already has a substance abuse problem and Attention Deficit Hyperactivity Disorder. This is dubbed "the younger sibling design." Families will be recruited via contacts in adolescent substance abuse treatment centers (e.g. Phoenix House, Odyssey House). Participating substance abuse treatment centers will inform families of our study. We will conduct two phone screens followed by an in person evaluation to determine eligibility. Relevant information includes family history with special emphasis on the growth and development of both children, as well as the results of a comprehensive clinical evaluation of the younger child. Subjects will therefore be the younger siblings of substance abusers in which both sibs have ADHD but only the older sib uses drugs or alcohol regularly. All subjects will receive active medication and all will be assessed weekly for the first three months of the study and monthly for three months thereafter. The assessments will focus on ADHD symptoms, substance use, and overall adolescent problem behaviors.

Arms: arm 1: Open Label Vyvanse (lisdexamphetamine) in doses of 30-70 mgs over 8 weeks in younger siblings of substance abusing older siblings with a history of treatment for ADHD
Interventions: intervention 1: Vyvanse
Intervention descriptions: intervention 1: Patients will be titrated from 30 mgs to 50 mgs to 70 mgs over four weeks, as tolerated and as needed to control ADHD symptoms

Protocol documents: