Substance-Related Disorders Clinical Trial
Official title:
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
| NCT number | NCT00247572 |
| Study type | Interventional |
| Source | New River Pharmaceuticals |
| Contact | |
| Status | Completed |
| Phase | Phase 2 |
| Start date | September 2005 |
| Completion date | November 2005 |
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.
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.
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
