PHASE IIA: Trial of a Novel Ondansetron Formulation (OND-PR002) and Immediate-Release Methylphenidate (Ritalin®)(OND003IND)
Status:
Completed
Trial end date:
2013-05-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
Tong Lee
Collaborators:
National Institute on Drug Abuse (NIDA) National Institutes of Health (NIH)