Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
New River Pharmaceuticals |
---|---|
Information provided by: | New River Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00247572 |
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.
Condition | Intervention | Phase |
---|---|---|
Attention Deficit Disorder With Hyperactivity Amphetamine-Related Disorders Substance-Related Disorders |
Drug: NRP104 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Dose Comparison, Crossover Assignment, Pharmacokinetics/Dynamics Study |
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 |
Estimated Enrollment: | 12 |
Study Start Date: | September 2005 |
Study Completion Date: | November 2005 |
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.
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Acceptable contraceptives include double barrier method (such as condom with spermicidal gel or diaphragm with spermicidal gel), IUDs and hormonal contraceptives which must be pharmacologically effective prior to study drug exposure.
Exclusion Criteria:
United States, Maryland | |
Johns Hopkins Bayview Medical Center, Clinical Studies Program | |
Baltimore, Maryland, United States, 21224 |
Principal Investigator: | Donald Jasinski, MD | Johns Hopkins University |
Study ID Numbers: | NRP104.A02, WIRB(R) Protocol #20051316 |
Study First Received: | October 31, 2005 |
Last Updated: | November 1, 2007 |
ClinicalTrials.gov Identifier: | NCT00247572 History of Changes |
Health Authority: | United States: Food and Drug Administration |
d-Amphetamine 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 Drug Abuse, Intravenous Intravenous Drug Abuse |
Behavior, Addictive Attention Deficit and Disruptive Behavior Disorders Disorders of Environmental Origin Dyskinesias Signs and Symptoms Methamphetamine Attention Deficit Disorder with Hyperactivity Amphetamine-Related Disorders |
Mental Disorders Dextroamphetamine Mental Disorders Diagnosed in Childhood Substance-Related Disorders Hyperkinesis Neurologic Manifestations Amphetamine |
Disease Nervous System Diseases Attention Deficit and Disruptive Behavior Disorders Disorders of Environmental Origin Dyskinesias Signs and Symptoms Pathologic Processes |
Attention Deficit Disorder with Hyperactivity Amphetamine-Related Disorders Mental Disorders Mental Disorders Diagnosed in Childhood Substance-Related Disorders Hyperkinesis Neurologic Manifestations |