Study to Evaluate the Likeability, Safety, and Abuse Potential of NRP 104 in Adults With Histories of Stimulant Abuse
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.
Attention Deficit Disorder With Hyperactivity
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Primary Purpose: Treatment
|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|
- 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.
|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.
|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|