PHASE IIA: Trial of a Novel Ondansetron Formulation (OND-PR002) and Immediate-Release Methylphenidate (Ritalin®)(OND003IND)

September 27, 2014 updated by: Tong Lee

PHASE IIA: Randomized, Double Blind, Placebo Controlled, Single Center Clinical Trial of a Combination of a Novel Ondansetron Formulation (OND-PR002) and Immediate-Release Methylphenidate (Ritalin®)

The main purpose of this study is to determine the outcome of a drug combination treatment on detoxified and stabilized methamphetamine (METH) and/or cocaine (COC) dependent users. The combination regimen consists of oral administration of a generic immediate-release methylphenidate (MPh-IR) formulation (e.g., Ritalin®) and a novel delayed, pulsatile-release formulation of the antiemetic ondansetron (Ond-PR002). Various psychological assessment tools and functional magnetic resonance imaging (fMRI) will be used to assess the treatment outcome. In addition to the treatment outcome measures, we will determine whether the 14-day, once-a-day treatment leads to significant changes in the pharmacokinetic/pharmacodynamic (PK/PD), safety and tolerability parameters of MPh-IR and/or Ond-PR002 formulations and drug-drug interactions between the two drugs.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke Clinical Research Unit
      • Durham, North Carolina, United States, 27705
        • Duke Addictions Clinic
      • Raleigh, North Carolina, United States, 27610
        • SouthLight

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects must give written informed consent.
  • Detoxified METH/COC-dependent male and/or female subjects between 18 and 45.
  • Females with Body Mass Index (BMI) of 18-36 kg/m2. Males with BMI of 20-36 kg/m2.
  • Subjects in good health determined by screening examination.
  • Subject must have adequate veins for intravenous site.
  • Subjects must be mentally stable for minimum of 3 months.
  • Non-clinically significant hematology clinical laboratory results.
  • Subjects must have hematocrit of greater than or equal to 33%.
  • Non-clinically significant screening 12-lead ECG and QT interval (time for ventricular depolarization and repolarization to occur) corrected by Fridericia formula (QTcF) of < 440 msec for male and < 460 msec for females.
  • Subjects must be right-handed (control for handed-related differences) in lateralized patterns of brain function.
  • Ability to identify visual cues during fMRI.
  • Subjects' VAS score must be above 20.

Exclusion Criteria:

  • Subjects who consume more than 28 units of alcohol per week.
  • Subjects who test positive for drugs of abuse or alcohol.
  • Current use of nicotine replacement therapy or other smoking cessation treatment.
  • Use of other investigational drugs within 30 days, or at least 5 half-lives of a study medication prior to enrollment.
  • Subjects being treated with other psychotropic drug will be excluded based on PI's clinical judgment and potential drug-drug adverse reactions with study drugs.
  • Subjects on prescribed, over-the-counter (OTC) or nutraceutical drugs that may influence the PK, safety or efficacy profiles of MPh-IR and/or Ond-PR002 will be excluded, or receive a washout prior to study enrollment. Subjects on drugs or substances known to be strong inhibitors or strong inducers of CYP 3A4/5 enzymes (enzymes involved in the metabolism of xenobiotics) or P-glycoprotein (P-gp) will be excluded in a similar manner.
  • Subjects with heart disease or uncontrolled high blood pressure.
  • Donation of any blood or plasma in the last month, or donation of >500mL of blood within the 3 months preceding study drug administration.
  • History of serious adverse reaction or allergies to any drug or any other products used in the study.
  • Allergies or intolerance to any of the products used in this study.
  • Subjects who have allergies to pork-derived medications or those that contain pork-derived products.
  • Inability to give informed consent or high likelihood of being unable to complete the necessary confinement.
  • Subjects deemed inappropriate for this study by the Principal Investigator.
  • Subjects with a documented brain abnormality, history of unexplained loss of consciousness, seizures, history of unexplained syncope, or history of transient ischemic attack or stroke within the past 6 months.
  • History of concurrent illness that required hospitalization within 14 days prior to Day 1 or a clinically significant illness within 4 weeks prior to Day 1.
  • History of clinically significant cardiovascular illness within the past 6 months.
  • History of clinically significant hepatic, renal, pulmonary, metabolic, endocrine, infectious, gastrointestinal, hematologic, oncologic, retinopathy, or other medical disorders.
  • History of unstable psychiatric illness requiring hospitalization within previous 6 months.
  • Subjects with history of glaucoma, color blindness or other uncorrected vision problem.
  • Subjects with QTcF interval duration greater than or equal to 440 msec (males) or greater than or equal to 460 msec (females) obtained from the 12-lead ECG recorder's measurements on the screening ECG.
  • Individuals with a major condition that would make fMRI participation unsafe or uncomfortable.
  • Females who are pregnant, breast-feeding or plan on becoming pregnant.
  • Subjects who have a hematocrit < 33% or hemoglobin < 12.0 g/dL.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Other: Placebo: Two dextrose capsules for Ond-PR002 and MPh-IR
Single daily oral doses
Other Names:
  • Placebo
Experimental: OND-PR002 and MPh-IR
Drug: OND-PR002 and MPh-IR

Drug: OND-PR002

Single daily oral doses of 8 mg Ond-PR002

Drug: MPh-IR

Single daily oral doses of 20 mg MPh-IR

Other Names:
  • Ritalin®
  • Methylphenidate
  • Zofran®
  • Ondanasetron

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Efficacy of combined Ond-PR002 and MPh-IR treatment
Time Frame: 15 days
Efficacy of combined Ond-PR002 and MPh-IR treatment in reducing the Visual Analogue Scale (VAS), Cocaine Selective Severity Assessment (CSSA) and Amphetamine Cessation Symptom Assessment (ACSA) craving scores in abstinent METH/COC abusers. Changes in cue-reactivity and inhibitory control deficits will be also assessed using functional magnetic resonance imaging (fMRI).
15 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Safety of combined MPh-IR + Ond-PR002 treatment
Time Frame: 15 days
Number of subjects with clinically significant changes in vital signs, electrocardiogram (ECG), hematology or chemistry panel measurements and number of subjects with self-reported or observed adverse events or serious adverse events will be recorded.
15 days
Changes in the PK parameters of Ond-PR002 PK after 14-day treatment
Time Frame: 15 days
Standard PK parameters of Ond-PR002 (e.g., maximum serum concentrations, time to reach max. concentration, apparent volume of distribution, etc.) will be calculated based on the serum drug concentrations, and statistical differences between Day 1 and Day 14 will be determined.
15 days
Changes in the PK parameters of MPh-IR PK after 14-day treatment
Time Frame: 15 days
Standard PK parameters of MPh-IR on Day 1 and Day 14 will be calculated and statistically compared as described for Ond-PR002.
15 days
Tolerability of combined MPh-IR + Ond-PR002 treatment
Time Frame: 15 days
Number of subjects with clinically significant changes in vital signs, electrocardiogram (ECG), hematology or chemistry panel measurements and number of subjects with self-reported or observed adverse events or serious adverse events will be recorded.
15 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tong Lee

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Drug Abuse (NIDA)
National Institutes of Health (NIH)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Robert J Noveck, MD,PhD, Duke Clinical Research Unit
  • Principal Investigator: Ashwin A Patkar, MD, Psychiatry and Behavioral Sciences
  • Principal Investigator: Tong Lee, MD, PhD, Associate Professor Psychiatry and Behavorial Science, Duke University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 12, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 20, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 21, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 7, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 27, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Pro00030921
  • 1RC2DA028905-01 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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