Pilot Study of Vyvanse™ In ADHD Adolescents at Risk for Substance Abuse
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): Vyvanse
Intervention type(s): Drug
Intervention description(s): 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
Other intervention name(s): Lisdexamphetamine is marketed as Vyvanse
Intervention MeSH terms: Lisdexamfetamine Dimesylate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Attention Deficit Hyperactivity Disorder; ADHD; ADD; Prevention; Substance use; Adolescent