Study to Evaluate the Likeability, Safety, and Abuse Potential of NRP 104 in Adults With Histories of Stimulant Abuse
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|ClinicalTrials.gov Identifier: NCT00248092|
Recruitment Status : Completed
First Posted : November 3, 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 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||36 participants|
|Intervention Model:||Crossover Assignment|
|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|
|Study Start Date :||January 2006|
|Actual Study Completion Date :||May 2006|
- The difference in the time to maximum change from baseline in the Liking scale score (Question 2) from the Drug Rating Questionnaire - Subject (DRQS).
- Maximum Liking score (Question 2 from DRQS) change from baseline
- Question 1 and 3 from the DRQS
- Question 1, 2 and 3 from the Drug Rating Questionnaire- Observer (DRQO)
- Subscale of the ARCI (MBG, Amphetamine, BG, LSD and PCAG) (subject)
- Street Value assessment Questionnaire (subject)
- Treatment Enjoyment assessment Questionnaire (TEAQ) (subject)
- Adverse events, laboratory tests, physical examination, vital signs and ECG will be collected to
- assess the safety and tolerability of NRP104.
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): NCT00248092
|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|