Ignite Creation Date:
2025-12-24 @ 3:16 PM
Ignite Modification Date:
2025-12-26 @ 1:22 AM
Study NCT ID:
NCT00248092
Status:
COMPLETED
Last Update Posted:
2007-11-05
First Post:
2005-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Evaluate the Likeability, Safety, and Abuse Potential of NRP 104 in Adults With Histories of Stimulant Abuse
Sponsor:
New River Pharmaceuticals
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2007-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: