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Attention Deficit Disorder With HyperactivityPhase 1/2NCT00248092

Study to Evaluate the Likeability, Safety, and Abuse Potential of NRP 104 in Adults With Histories of Stimulant Abuse

A Phase 1/2 study testing NRP104 in people with Attention Deficit Disorder With Hyperactivity and Amphetamine-Related Disorders, run by New River Pharmaceuticals at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
What is being tested?
NRP104
How many people
36 participants
Where
1 siteUnited States
Study dates
Jan 2006to May 2006
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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. 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.
  • Subject must be in good health and have venous access sufficient for 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 14 days, and will be able to complete all protocol-specified assessments.
  • Able to understand that they can withdraw from the study at any time.
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  • 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.
  • Able to swallow the study medication whole.

Who cannot join

  • History of clinically significant gastrointestinal, renal, hepatic, endocrine, oncologic, hematologic, neurologic, psychologic, immunologic or pulmonary disorders; or cardiovascular disease, tuberculosis, epilepsy, diabetes, psychosis, glaucoma, or any condition which in the opinion of the Investigator would jeopardize the safety of the subject or impact study results or prevent the subject from completing the study.
  • Presence or history of any medically diagnosed, clinically significant Axis I psychiatric disorders other than substance abuse (including bipolar disorder, any psychotic disorder, and Tourette's disorder or family history of Tourette's).
  • Serious suicidal risk determined by the investigator.
  • Presence of a severe learning difficulty or mental retardation, or any condition that would interfere with participation or completion of the study.
  • History of allergic or adverse response or hypersensitivity to d-amphetamine or NRP104.
  • Participation in a previous clinical trial within 30 days prior to study initiation.
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  • Blood loss, donation of one pint or more, or plasma donation within 60 days prior to study initiation.
  • Clinically significant abnormalities at screening or admission on results of ECG or lab tests, including lab deviations requiring acute medical intervention or further medical attention.
  • Treated with a monoamine oxidase inhibitor, currently or within 13 days of initiation of the study medication.
  • Require any of the following medications: clonidine or other alpha-2 adrenergic receptor agonists, tricyclic antidepressants, selective serotonin reuptake inhibitors (SSRIs) theophylline, coumarin anticoagulants, or anticonvulsants; or have taken an SSRI in the 35 days before initiation of the study medication.
  • Currently physically dependent on benzodiazepines as determined by clinical evaluation and/or urine drug screen at screening.
  • Currently physically dependent on opiates as determined by naloxone challenge.
  • Currently physically dependent on alcohol as determined by clinical evaluation or has a confirmed positive Breathalyzer test at screening or admission.
  • Preexisting severe gastrointestinal narrowing.
  • Use of any prescription medications (except birth control) within 14 days of admission, or will require any prescription medications, or any over-the-counter (OTC) medications (other than acetaminophen), or herbal supplements or vitamins during the study.
  • Positive urine pregnancy test at screening or admission.
  • Female subject is pregnant or lactating.
  • Related to any person directly or indirectly involved with the conduct of the study or currently participating in the study.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Johns Hopkins Bayview Medical Center, Clinical Studies Program

    Baltimore, Maryland, 21224

Other trials in United States

About this study

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

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.

Read the detailed description

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.

Being tested
NRP104
Keywords
d-Amphetamine, Diethylpropion, Diethylpropion Hydrochloride, Attention Deficit Hyperactivity Disorder, Attention Deficit Disorders with Hyperactivity, Attention Deficit Hyperactivity Disorders, Amphetamine Abuse, Amphetamine Dependence, Amphetamine Addiction, Amphetamine Users, Drug Abuse, Drug Addiction, Drug Dependence, Drug Habituation, Drug Use Disorders, Substance Abuse, Substance Dependence, Substance Use Disorders, Drug Usage, Substance Addiction
Medical subject headings
Attention Deficit Disorder with Hyperactivity, Amphetamine-Related Disorders, Substance-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NRP104Drug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The difference in the time to maximum change from baseline in the Liking scale score (Question 2) from the Drug Rating Questionnaire - Subject (DRQS).

Secondary outcomes (9)

  1. Maximum Liking score (Question 2 from DRQS) change from baseline

  2. Question 1 and 3 from the DRQS

  3. Question 1, 2 and 3 from the Drug Rating Questionnaire- Observer (DRQO)

  4. Subscale of the ARCI (MBG, Amphetamine, BG, LSD and PCAG) (subject)

  5. Street Value assessment Questionnaire (subject)

  6. Treatment Enjoyment assessment Questionnaire (TEAQ) (subject)

  7. Safety

  8. Adverse events, laboratory tests, physical examination, vital signs and ECG will be collected to

  9. assess the safety and tolerability of NRP104.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Nov 2005 (estimated)
  2. Study startJan 2006
  3. Study completionMay 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Enrolment
36 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00248092
Sponsor's protocol ID
NRP104.A03
Status last verified
Nov 2007
First submitted
1 Nov 2005
Last updated
5 Nov 2007
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing NRP104 in people with Attention Deficit Disorder With Hyperactivity and Amphetamine-Related Disorders, run by New River Pharmaceuticals at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Nov 2007. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The difference in the time to maximum change from baseline in the Liking scale score (Question 2) from the Drug Rating Questionnaire - Subject (DRQS).. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00248092.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2007.

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