NCT01377662View on ClinicalTrials.gov

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

PHASE2CompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

August 31, 2011

Primary Completion Date

May 31, 2013

Study Completion Date

May 31, 2013

Conditions
Methamphetamine DependenceCocaine 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

Trial Locations (3)

27610

SouthLight, Raleigh

27705

Duke Addictions Clinic, Durham

27710

Duke Clinical Research Unit, Durham

All Listed Sponsors
collaborator

National Institutes of Health (NIH)

NIH

collaborator

National Institute on Drug Abuse (NIDA)

NIH

lead

Tong Lee

OTHER

NCT01377662 - PHASE IIA: Trial of a Novel Ondansetron Formulation (OND-PR002) and Immediate-Release Methylphenidate (Ritalin®)(OND003IND) | Biotech Hunter | Biotech Hunter