NCT01377662

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

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®)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Tong Lee · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2011-08-01
• Primary completion: 2013-05-01
• Completion: 2013-05-01
• First posted: 2011-06-21
• Last updated: 2014-10-07

Locations

3 sites across 1 country: United States