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

NCT01377662 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2014-10-07

No results posted yet for this study

Summary

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.

Conditions

  • Methamphetamine Dependence
  • Cocaine Dependence

Interventions

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

Placebo: Two dextrose capsules for Ond-PR002 and MPh-IR

Single daily oral doses

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • National Institutes of Health (NIH)

    collaborator NIH

  • Tong Lee

    lead OTHER

Principal Investigators

  • Robert J Noveck, MD,PhD · Duke Clinical Research Unit

  • Ashwin A Patkar, MD · Psychiatry and Behavioral Sciences

  • Tong Lee, MD, PhD · Associate Professor Psychiatry and Behavorial Science, Duke University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2013-05-31
Completion
2013-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01377662 on ClinicalTrials.gov