Attention Deficit Disorder With HyperactivityPhase 2NCT00247572
Safety, Tolerability and Abuse Liability Study of Intravenous NRP104 in Adults With Stimulant Abuse Histories
A Phase 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.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Attention Deficit Disorder With Hyperactivity, Amphetamine-Related Disorders, Substance-Related Disorders
- What is being tested?
- NRP104
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2005to Nov 2005
- Phase
- Phase 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 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.
Show all 9Show fewer
- 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.
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.
Show all 18Show fewer
- 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 positive Breathalyzer test at screening or admission and confirmed by a second reading.
- Preexisting severe gastrointestinal narrowing.
- Use of any prescription medications (except birth control methods) 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.
- Another member of the subject's household 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
About this study
Official title: A Double-Blind Placebo- and Active-Controlled, Single-Dose Crossover PD and PK Study to Evaluate the Safety, Tolerability and Abuse Liability of IV Administered NRP104 25 mg and 50 mg in Adult Volunteers With Histories of Stimulant Abuse
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.
Read the detailed description
There is a need for a non-scheduled stimulant medication that can provide symptom control for children with ADHD as the conventional stimulant products do.
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. New River Pharmaceuticals has developed three NRP104 dose strengths of 30 mg, 50 mg, and 70 mg to provide amphetamine base equivalent to Adderall XR (R) 10 mg, 20 mg, and 30 mg, respectively. Adderall XR (R) and other amphetamine and methylphenidate containing preparations are liable to intravenous abuse.
As part of the development of NRP104 for treatment of children with ADHD, it is important to evaluate the abuse potential of NRP104 given intravenously in comparison to immediate release d-amphetamine. This study will conduct relevant information to address appropriately the objectives of determining abuse potential of intravenously administered NRP104.
- Conditions
- Attention Deficit Disorder With Hyperactivity, Amphetamine-Related Disorders, Substance-Related Disorders
- Being tested
- NRP104
- Keywords
- d-Amphetamine, 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, Drug Abuse, Intravenous, Intravenous Drug Abuse
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Amphetamine-Related Disorders, Substance-Related Disorders, Substance Abuse, Intravenous
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.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2005 (estimated)
- Study startSep 2005
- Study completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Disorder With HyperactivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 12 participants
Sponsor and investigators
- Lead sponsor
- New River Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Donald Jasinski, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00247572
- Sponsor's protocol ID
- NRP104.A02
- Other IDs
- WIRB(R) Protocol #20051316
- Status last verified
- Nov 2007
- First submitted
- 31 Oct 2005
- Last updated
- 5 Nov 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind Placebo- and Active-Controlled, Single-Dose Crossover PD and PK Study to Evaluate the Safety, Tolerability and Abuse Liability of IV Administered NRP104 25 mg and 50 mg in Adult Volunteers With Histories of Stimulant Abuse
- ClinicalTrials.gov ID
- NCT00247572
- Acronym / sponsor ID
- NRP104.A02
- Conditions
- Attention Deficit Disorder With Hyperactivity, Amphetamine-Related Disorders, Substance-Related Disorders
- Keywords
- d-Amphetamine, Attention Deficit Hyperactivity Disorder, Attention Deficit Disorders with Hyperactivity, Attention Deficit Hyperactivity Disorders, Amphetamine Abuse, Amphetamine Dependence, Amphetamine Addiction, Amphetamine Users
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants
- Lead sponsor
- New River PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Sep 2005
- Study completion
- Nov 2005 (actual)
- First posted
- 2 Nov 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
There is a need for a non-scheduled stimulant medication that can provide symptom control for children with ADHD as the conventional stimulant products do.
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. New River Pharmaceuticals has developed three NRP104 dose strengths of 30 mg, 50 mg, and 70 mg to provide amphetamine base equivalent to Adderall XR (R) 10 mg, 20 mg, and 30 mg, respectively. Adderall XR (R) and other amphetamine and methylphenidate containing preparations are liable to intravenous abuse.
As part of the development of NRP104 for treatment of children with ADHD, it is important to evaluate the abuse potential of NRP104 given intravenously in comparison to immediate release d-amphetamine. This study will conduct relevant information to address appropriately the objectives of determining abuse potential of intravenously administered NRP104.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NRP104 | Drug | – |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2007.
Related trials for Attention Deficit Disorder With Hyperactivity
Enrolling by invitationPhase 3
An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
ADHD
RecruitingObservational study
Augmenting Parent Management Training for Child Temper Outbursts Using a Digital Tool
Disruptive Behavior Disorders, Conduct Disorder
Recruiting
Micronutrient Supplementation and Chronotherapy in Children With ADHD
Attention Deficit Hyperactivity Disorder (ADHD)
RecruitingPhase 3
Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol (FOCUS-2)
ADHD
RecruitingPhase 3
A Study to Test the Effects of Centanafadine in Adults With Attention-deficit/Hyperactivity Disorder and Emotional Dysregulation
Attention-deficit/Hyperactivity Disorder, Emotional Dysregulation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Donald Jasinski, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 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 phase mean?
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?
Pharmacodynamic (PD) Parameters:. The study lists 19 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.