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NCT01377662 · ClinicalTrials.gov registry record · Phase 2
PHASE IIA: Trial of a Novel Ondansetron Formulation (OND-PR002) and Immediate-Release Methylphenidate (Ritalin®)(OND003IND)
A Phase 2 study of Cocaine Dependence and Methamphetamine-dependence, sponsored by Tong Lee.
- Completed
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
- 3
- Study locations
NCT01377662 is a Phase 2 study of Cocaine Dependence and Methamphetamine-dependence that has completed, run by Tong Lee. The registered enrollment target is 30 participants, below the 298-participant average among 38 other Cocaine Dependence trials with a reported enrollment target (90% lower). The trial reports 3 study locations across 1 state.
The verdict
NCT01377662, a Phase 2 study of Cocaine Dependence and Methamphetamine-dependence, has completed, sponsored by Tong Lee.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
- 3
- Study locations
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 Studied
Interventions
- DRUG OND-PR002 and MPh-IR
- OTHER Placebo: Two dextrose capsules for Ond-PR002 and MPh-IR
Study Locations (3)
North Carolina
- Duke Addictions Clinic - Durham
- Duke Clinical Research Unit - Durham
- SouthLight - Raleigh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2011-08 |
| Est. Completion | 2013-05 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01377662
The ClinicalTrials.gov registry entry for NCT01377662 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 298-participant average among 38 other Cocaine Dependence trials with a reported enrollment target (90% lower). The listed sponsor is Tong Lee, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Cocaine Dependence appearing as the primary indexed condition, and to 2 interventions - of which OND-PR002 and MPh-IR is the first listed.
NCT01377662 reports 3 study locations spanning 1 distinct geographic area - top geographies include North Carolina.
Frequently Asked Questions
What is clinical trial NCT01377662 about?
NCT01377662 is a clinical study titled "PHASE IIA: Trial of a Novel Ondansetron Formulation (OND-PR002) and Immediate-Release Methylphenidate (Ritalin®)(OND003IND)". 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) formula...
What is the current status of trial NCT01377662?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2011-08. Estimated completion is 2013-05.
What conditions does trial NCT01377662 study?
This clinical trial studies the following conditions: Cocaine Dependence, Methamphetamine-dependence.
What interventions are being tested in trial NCT01377662?
The interventions under investigation include: OND-PR002 and MPh-IR (DRUG), Placebo: Two dextrose capsules for Ond-PR002 and MPh-IR (OTHER).
Who is sponsoring clinical trial NCT01377662?
This trial is sponsored by Tong Lee, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01377662 being conducted?
This trial has 3 study locations across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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