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NCT01759446 · ClinicalTrials.gov registry record · Phase 2
Abuse Potential of Intranasal VYCAVERT Tablets (Hydrocodone Bitartrate/Acetaminophen) in Recreational Opioid Users
A Phase 2 study of Opioid-Related Disorders, sponsored by Acura Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 44
- Enrollment target
- 1
- Study location
NCT01759446: Completed Phase 2 study of Opioid-Related Disorders, sponsored by Acura Pharmaceuticals.
NCT01759446 is a Phase 2 study of Opioid-Related Disorders that has completed, run by Acura Pharmaceuticals. The registered enrollment target is 44 participants, below the 346-participant average among 47 other Opioid-Related Disorders trials with a reported enrollment target (87% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01759446, a Phase 2 study of Opioid-Related Disorders, has completed, sponsored by Acura Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 44 participants
- Enrollment target
- 1
- Study location
Study Summary
To determine the relative abuse potential of VYCAVERT (hydrocodone bitartrate and acetaminophen) compared to GENERIC H/A (hydrocodone bitartrate and acetaminophen) when crushed and administered intranasally to non dependent, recreational opioid users.
Primary Outcome
"Do you dislike or like the drug effect you are feeling now?" The question is scored using a 100-point bipolar visual analog scale (VAS) anchored in the center with "neither like nor dislike" (score of 50), on the left with "Strong Disliking" (score of 0) and on the right with "Strong Liking" (score of 100). Maximum Score. Assessment were made at 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, and 8 hours post-dosing.
Conditions Studied
Interventions
- DRUG Placebo taken first
- DRUG Generic H/A taken first
- DRUG Vycavert taken first
- DRUG Generic H/A plus i taken first
- DRUG Generic H/A plus p taken first
Study Locations (1)
Utah
- Lifetree Clinical Research - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2013-02 |
| Est. Completion | 2013-04 |
| Phase | Phase 2 |
What the finished NCT01759446 record still lists
NCT01759446 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 346-participant average among 47 other Opioid-Related Disorders trials with a reported enrollment target (87% lower).
The record links to 1 condition, with Opioid-Related Disorders appearing as the primary indexed condition, and to 5 interventions - of which Placebo taken first is the first listed.
NCT01759446 reports a single indexed study location in Utah.
Frequently Asked Questions
What is clinical trial NCT01759446 about?
NCT01759446 is a clinical study titled "Abuse Potential of Intranasal VYCAVERT Tablets (Hydrocodone Bitartrate/Acetaminophen) in Recreational Opioid Users". To determine the relative abuse potential of VYCAVERT (hydrocodone bitartrate and acetaminophen) compared to GENERIC H/A (hydrocodone bitartrate and acetaminophen) when crushed and administered intranasally to non dependent, recreational opioid users.
What is the current status of trial NCT01759446?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 44 participants. The study started on 2013-02. Estimated completion is 2013-04.
What conditions does trial NCT01759446 study?
This clinical trial studies the following conditions: Opioid-Related Disorders.
What interventions are being tested in trial NCT01759446?
The interventions under investigation include: Placebo taken first (DRUG), Generic H/A taken first (DRUG), Vycavert taken first (DRUG), Generic H/A plus i taken first (DRUG), Generic H/A plus p taken first (DRUG).
Who is sponsoring clinical trial NCT01759446?
This trial is sponsored by Acura Pharmaceuticals, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01759446 being conducted?
This trial has 1 study location across Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Opioid-Related Disorders
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01759446's enrollment target sits among peer trials
44 34th of 47 higher than 14 of 47 other Opioid-Related Disorders trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Opioid-Related Disorders 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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