Ignite Creation Date:
2024-05-05 @ 12:07 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00247572
Status:
COMPLETED
Last Update Posted:
2007-11-04
First Post:
2005-10-31
Brief Title:
Safety Tolerability and Abuse Liability Study of Intravenous NRP104 in Adults With Stimulant Abuse Histories
Sponsor:
New River Pharmaceuticals
Organization:
New River Pharmaceuticals
Study Overview
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
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 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| WIRBR Protocol 20051316 | None | None | None |