CompletedPhase 2

Safety, Tolerability and Abuse Liability Study of Intravenous NRP104 in Adults With Stimulant Abuse Histories

United States12 participantsStarted 2005-09

Plain-language 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.

Who can participate

Age range

18 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Male or female subject is 18 to 55 years of age, inclusive. * Except for women who are post menopausal or surgically sterile, all female subjects must have a negative urine pregnancy test at screening and at admission to the research unit. They must abstain from sexual activity, or use acceptable contraceptives throughout the study, and for 30 days after the last dose of study drug. Acceptable contraceptives include double barrier method (such as condom with spermicidal gel or diaphragm with spermicidal gel), IUDs and hormonal contraceptives which must be pharmacologically effective prior to study drug exposure. * Meet DSM-IV criteria for the diagnosis of substance abuse. * Have a history of IV drug use. * Subject must be in good health and have venous access sufficient for (1) IV drug administration and (2) blood collection, as determined by medical history, physical exam, and clinical labs. * Agree to be admitted to the inpatient research unit for a minimum of 8 days, and be able to complete all protocol-specified assessments. * Able to understand that they can withdraw from the study at any time. * Minimum reading level of Grade Six as determined by the REALM test, at the investigator's discretion. * Subject must voluntarily consent to participate in this study. Exclusion Criteria: * History of clinically significant gastrointestinal, renal, hepatic, endocrine, oncologic, hematologic, neurologic, psychologic, immunologic or pulmonary disorders; or …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Trial details

NCT IDNCT00247572

SponsorNew River Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

View on ClinicalTrials.gov More Attention Deficit Disorder With Hyperactivity trials