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Sponsored by: |
New River Pharmaceuticals |
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Information provided by: | New River Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00248092 |
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.
Condition | Intervention | Phase |
---|---|---|
Attention Deficit Disorder With Hyperactivity Amphetamine-Related Disorders Substance-Related Disorders |
Drug: NRP104 |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Dose Comparison, Crossover Assignment, Pharmacodynamics Study |
Official Title: | A Double-Blind, Randomized, Placebo and Active-Controlled, Six-Period Crossover Study to Evaluate the Likeability, Safety, and Abuse Liability of NRP104 in Healthy Adult Volunteers With Histories of Stimulant Abuse |
Estimated Enrollment: | 36 |
Study Start Date: | January 2006 |
Study Completion Date: | May 2006 |
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.
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Maryland | |
Johns Hopkins Bayview Medical Center, Clinical Studies Program | |
Baltimore, Maryland, United States, 21224 |
Principal Investigator: | Donald R. Jasinski, MD | Johns Hopkins University |
Study ID Numbers: | NRP104.A03 |
Study First Received: | November 1, 2005 |
Last Updated: | November 1, 2007 |
ClinicalTrials.gov Identifier: | NCT00248092 |
Health Authority: | United States: Food and Drug Administration |
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 |
Behavior, Addictive Diethylpropion Attention Deficit and Disruptive Behavior Disorders Disorders of Environmental Origin Healthy Dyskinesias Diphenoxylate 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 |
Anti-Obesity Agents Pathologic Processes Disease Therapeutic Uses |
Nervous System Diseases Appetite Depressants Central Nervous System Agents Pharmacologic Actions |