Safety, Tolerability and Abuse Liability Study of Intravenous NRP104 in Adults With Stimulant Abuse Histories
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|ClinicalTrials.gov Identifier: NCT00247572|
Recruitment Status : Completed
First Posted : November 2, 2005
Last Update Posted : November 5, 2007
|Condition or disease||Intervention/treatment||Phase|
|Attention Deficit Disorder With Hyperactivity Amphetamine-Related Disorders Substance-Related Disorders||Drug: NRP104||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||12 participants|
|Intervention Model:||Crossover Assignment|
|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|
|Study Start Date :||September 2005|
|Actual Study Completion Date :||November 2005|
- Pharmacodynamic (PD) Parameters:
- The following parameters will be measured at fixed time intervals post drug and used to compare the
- effects of various doses of NRP104 with placebo and d-amphetamine sulfate for pharmacodynamic
- (1) Maximum liking scale scores for euphoria measured by DRQS and DRQO
- (2) Maximum disliking scale scores for dysphoria measured by DRQS and DRQO
- (3) Maximum scores on the MBG, BG and Amphetamine scales of the ARCI
- (4) Maximum supine systolic and diastolic blood pressure changes from baseline
- (5) Maximum orthostatic pulse increases from baseline
- (6) Spontaneous reports of discomforting subjective effects
- (7) Adverse events, laboratory tests, physical examination, vital signs and ECG will be collected to
- assess the safety and tolerability of NRP104.
- Pharmacokinetic (PK) Parameters
- The following parameters will be calculated using non-compartmental analysis for d-amphetamine and
- NRP104: AUC0-24, Cmax , Tmax.
- • AUC0-24: Area under the drug concentration-time curve from time zero to 24 hours post dose.
- • Cmax: Maximum observed drug concentration from zero hour to 24 hours post dose.
- • Tmax: Time at which Cmax occurs.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00247572
|United States, Maryland|
|Johns Hopkins Bayview Medical Center, Clinical Studies Program|
|Baltimore, Maryland, United States, 21224|
|Principal Investigator:||Donald Jasinski, MD||Johns Hopkins University|