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.
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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
equivalence:
(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
intact
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.