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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: Completed Phase 2 study of Cocaine Dependence and Methamphetamine-dependence, sponsored by Tong Lee.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Efficacy of combined Ond-PR002 and MPh-IR treatment in reducing the Visual Analogue Scale (VAS), Cocaine Selective Severity Assessment (CSSA) and Amphetamine Cessation Symptom Assessment (ACSA) craving scores in abstinent METH/COC abusers. Changes in cue-reactivity and inhibitory control deficits will be also assessed using functional magnetic resonance imaging (fMRI).
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 |
What the finished NCT01377662 record still lists
NCT01377662 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 298-participant average among 38 other Cocaine Dependence trials with a reported enrollment target (90% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT01377662's enrollment target sits among peer trials
30 31st of 38 higher than 8 of 38 other Cocaine Dependence trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cocaine Dependence trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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