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NCT01596673 · ClinicalTrials.gov registry record · Phase 1
A Study to Assess the Abuse Potential of Hydrocodone Extended-Release Tablet in Recreational Opioid Users
A Phase 1 study, sponsored by Cephalon.
- Completed
- Registry status
- Phase 1
- Development phase
- 100
- Enrollment target
NCT01596673: Completed Phase 1 study, sponsored by Cephalon.
NCT01596673 is a Phase 1 study that has completed, run by Cephalon. The registered enrollment target is 100 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01596673, a Phase 1 study, has completed, sponsored by Cephalon.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 100 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the relative abuse potential of the hydrocodone bitartrate extended-release tablet compared to immediate-release hydrocodone bitartrate.
Primary Outcome
The DLEQ measures positive, negative, and any drug effects using bipolar and unipolar VAS. Bipolar VAS range from a strong negative response (score of 0) to a strong positive response (score of 100) with a neutral midpoint (score of 50). Unipolar VAS range from a response of 'none' (score of 0) to 'extremely' (score of 100). Questions include assessments of liking, drowsiness, good effects, bad effects, nausea,and any effects. The primary outcome is question 1 which states: "My liking for this d
Interventions
- DRUG Placebo
- DRUG 45-mg hydrocodone bitartrate extended-release tablet (crushed or intact)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2012-03 |
| Est. Completion | 2012-05 |
| Phase | Phase 1 |
What the finished NCT01596673 record still lists
NCT01596673 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01596673 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01596673 about?
NCT01596673 is a clinical study titled "A Study to Assess the Abuse Potential of Hydrocodone Extended-Release Tablet in Recreational Opioid Users". The purpose of this study is to assess the relative abuse potential of the hydrocodone bitartrate extended-release tablet compared to immediate-release hydrocodone bitartrate.
What is the current status of trial NCT01596673?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 100 participants. The study started on 2012-03. Estimated completion is 2012-05.
What interventions are being tested in trial NCT01596673?
The interventions under investigation include: Placebo (DRUG), 45-mg hydrocodone bitartrate extended-release tablet (crushed or intact) (DRUG).
Who is sponsoring clinical trial NCT01596673?
This trial is sponsored by Cephalon, which has 64 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01596673's enrollment target sits among peer trials
100 546th of 2000 higher than 1,411 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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