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

NCT ID: NCT00573534

Last Updated: 2017-02-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-03-31
• Study Completion Date: 2010-03-31

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.

Conditions

Attention Deficit Hyperactivity Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Open Label Vyvanse

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

Group Type: EXPERIMENTAL

Vyvanse

Intervention Type: DRUG

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

Interventions

Vyvanse

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 Type: DRUG

Other Intervention Names

Lisdexamphetamine is marketed as Vyvanse

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

• Minimum Eligible Age: 11 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

New York State Psychiatric Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephen J Donovan, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University / New York State Psychiatric Institute

Other Identifiers

5522

Identifier Type: -

Identifier Source: org_study_id