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NCT01380093 · ClinicalTrials.gov registry record · Phase 1
Abuse Potential of Orally Administered Crushed Embeda Compared to Crushed Controlled-Release Morphine and Placebo in Non-Dependent Recreational Opioid Users
A Phase 1 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 1
- Development phase
- 80
- Enrollment target
NCT01380093: Completed Phase 1 study, sponsored by Pfizer.
NCT01380093 is a Phase 1 study that has completed, run by Pfizer. The registered enrollment target is 80 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01380093, a Phase 1 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 80 participants
- Enrollment target
Study Summary
The primary purpose of this study is to determine the abuse potential of EMBEDA compared to controlled release morphine when crushed and taken orally by non-dependent recreational opioid users; secondary purposes include to determine the abuse potential of crushed EMBEDA relative to placebo and and to compare the pharmacokinetics and safety of crushed EMBEDA with crushed controlled-release morphine and crushed placebo.
Primary Outcome
Drug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 millimeter (mm) bipolar visual analogue scale (VAS) anchored in the center with a neutral anchor of "neither like nor dislike" (score of 50 mm), on the left with "strong disliking" (score of 0 mm) and on the right with "strong liking" (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hours (hrs) (0-
Interventions
- DRUG Placebo
- DRUG MS Contin (morphine sulfate, controlled release)
- DRUG EMBEDA (morphine sulfate / naltrexone hydrochloride)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2011-02 |
| Est. Completion | 2011-05 |
| Phase | Phase 1 |
What the finished NCT01380093 record still lists
NCT01380093 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01380093 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01380093 about?
NCT01380093 is a clinical study titled "Abuse Potential of Orally Administered Crushed Embeda Compared to Crushed Controlled-Release Morphine and Placebo in Non-Dependent Recreational Opioid Users". The primary purpose of this study is to determine the abuse potential of EMBEDA compared to controlled release morphine when crushed and taken orally by non-dependent recreational opioid users; secondary purposes include to determine the abuse potential of crushed EMBEDA relative to placebo and and ...
What is the current status of trial NCT01380093?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 80 participants. The study started on 2011-02. Estimated completion is 2011-05.
What interventions are being tested in trial NCT01380093?
The interventions under investigation include: Placebo (DRUG), MS Contin (morphine sulfate, controlled release) (DRUG), EMBEDA (morphine sulfate / naltrexone hydrochloride) (DRUG).
Who is sponsoring clinical trial NCT01380093?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01380093's enrollment target sits among peer trials
80 672nd of 2000 higher than 1,305 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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