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
Intervention: Vyvanse
Intervention description: 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
Intervention MeSH terms: Lisdexamfetamine Dimesylate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Minimum age: 11 Years
Maximum age: 15 Years
Healthy volunteers: No
Keywords: Attention Deficit Hyperactivity Disorder; ADHD; ADD; Prevention; Substance use; Adolescent

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Meets DSM-IV-TR criteria for ADHD

          -  Has a Gender-Matched older sibling with ADHD and substance dependence

          -  Medically healthy

          -  Parents give informed consent

          -  Child gives assent

        Exclusion Criteria:

          -  Significant use of alcohol or marijuana (more than ten episodes) in the past 30 days
             or any use of cocaine or opiates in the past 30 days; significant nicotine use is not
             an exclusion

          -  History of cardiac abnormality, past cardiac problems or family history of the same,
             history of fainting, open-heart surgery, and arrhythmia

          -  History of paranoia on stimulant medication

          -  Seizure or other neurological disturbance

          -  Pregnancy

          -  Moderate to severe mental deficiency as determined by IQ <60 or placement in special
             education for mental deficiency

          -  Physical exam or laboratory results with significant abnormalities

          -  Active suicidal or homicidal ideation or history of suicide attempts

          -  Unequivocal manic or hypomanic episode

          -  Sexually active females who are unwilling to use effective methods of contraception

          -  Psychosis or psychosis in a first degree relative

          -  Current Major Depression

          -  Individuals who have previously seen a cardiologist until reevaluated by a
             cardiologist

          -  Individuals for whom the current cardiac evaluation is not definitive until seen by a
             cardiologist and given an echocardiogram

          -  Individuals with Tic disorder

          -  Significant co-morbid anxiety disorders (i.e., OCD, Panic, PTSD)

          -  ADHD in remission on another psychostimulant or not in remission but in the context of
             inadequate dosing of a currently prescribed and administered other psychostimulant