NCT00247572

Safety, Tolerability and Abuse Liability Study of Intravenous NRP104 in Adults With Stimulant Abuse Histories

A Double-Blind Placebo- and Active-Controlled, Single-Dose Crossover PD and PK Study to Evaluate the Safety, Tolerability and Abuse Liability of IV Administered NRP104 25 mg and 50 mg in Adult Volunteers With Histories of Stimulant Abuse

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (planned)
• Sponsor: New River Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This research is being done to evaluate if NRP 104 is a safe drug. The other purpose is to learn if NRP104, when injected into a vein, 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. 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 non-scheduled stimulant medication that can provide symptom control for children with ADHD as the conventional stimulant products do. 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. New River Pharmaceuticals has developed three NRP104 dose strengths of 30 mg, 50 mg, and 70 mg to provide amphetamine base equivalent to Adderall XR (R) 10 mg, 20 mg, and 30 mg, respectively. Adderall XR (R) and other amphetamine and methylphenidate containing preparations are liable to intravenous abuse. As part of the development of NRP104 for treatment of children with ADHD, it is important to evaluate the abuse potential of NRP104 given intravenously in comparison to immediate release d-amphetamine. This study will conduct relevant information to address appropriately the objectives of determining abuse potential of intravenously administered NRP104.

Conditions

• Attention Deficit Disorder With Hyperactivity
• Amphetamine-Related Disorders
• Substance-Related Disorders

Interventions

Type	Name	Description
DRUG	NRP104

Timeline

• Start date: 2005-09-01
• Completion: 2005-11-01
• First posted: 2005-11-02
• Last updated: 2007-11-05

Locations

1 site across 1 country: United States