Pilot Study of Vyvanse™ In ADHD Adolescents at Risk for Substance Abuse

• Status: Completed
• Trial end date: 2010-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: New York State Psychiatric Institute
• Treatments: Lisdexamfetamine Dimesylate

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