Study to Evaluate the Likeability, Safety, and Abuse Potential of NRP 104 in Adults With Histories of Stimulant Abuse
Condition: Attention Deficit Disorder With Hyperactivity; Amphetamine-Related Disorders; Substance-Related Disorders
MeSH terms: Hyperkinesis; Substance-Related Disorders; Amphetamine-Related Disorders; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This research is being done to evaluate if NRP104 is a safe drug. The other purpose is to
      learn if NRP104 produces a high and any other effects like amphetamine and other stimulant
      drugs that are abused. This information will give some indication if NRP104 can be abused.
      NRP104 is an investigational drug. This means that it has not been approved by the U.S. Food
      and Drug Administration (FDA). Healthy people, between the ages of 18 and 55 with histories
      of substance abuse that include stimulant drugs, may join. Amphetamines are drugs that are
      used most often to treat attention deficit hyperactivity disorder (ADHD) in children, to
      treat narcolepsy (excessive sleepiness) and for weight loss.
    

Detailed description: 
      There is a need for a less abusable stimulant medication that can provide symptom control for
      children with ADHD as compared to the conventional stimulant products.

      Currently, the top line amphetamine product Adderall XR(R) for the treatment of children with
      ADHD involves a once-a-day morning dosing of up to 30 mg per day per Adderall XR(R) Package
      Insert. Adderall XR(R) has potential for abuse and is hence is classified as a schedule II
      product.

      As part of the development of NRP104 for treatment of children with ADHD, it is important to
      evaluate the abuse potential of NRP104 in comparison to immediate release d-amphetamine. A
      previous exploratory dose ranging study (NRP104.A01) with NRP104 demonstrated that doses of
      NRP104 up to 150 mg are safe and produce effects equal to or less than 40 mg of immediate
      release d-amphetamine. When compared with those of d-amphetamine, diethylproion produced
      effects qualitatively similar to those of d-amphetamine but were significantly less potent.
      Intravenous and subcutaneous routes diethylpropion was less potent as compared to oral route
      (Jasinski et al; 1974). This larger study is designed to compare the abuse potential of
      NRP104 with the Schedule II d-amphetamine sulfate and the Schedule IV diethylpropion
      hydrochloride. Data collected from this study will be used to evaluate the abuse potential of
      NRP104.
    

Intervention name(s): NRP104
Intervention type(s): Drug
Intervention MeSH terms: Lisdexamfetamine Dimesylate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: d-Amphetamine; Diethylpropion; Diethylpropion Hydrochloride; Attention Deficit Hyperactivity Disorder; Attention Deficit Disorders with Hyperactivity; Attention Deficit Hyperactivity Disorders; Amphetamine Abuse; Amphetamine Dependence; Amphetamine Addiction; Amphetamine Users; Drug Abuse; Drug Addiction; Drug Dependence; Drug Habituation; Drug Use Disorders; Substance Abuse; Substance Dependence; Substance Use Disorders; Drug Usage; Substance Addiction