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NCT05319756 · ClinicalTrials.gov registry record · Phase 4
Study Evaluating the Abuse Potential of NEURONTIN® in Healthy Non-drug Dependent, Recreational Opioid Users
A Phase 4 study, sponsored by Viatris Specialty.
- Completed
- Registry status
- Phase 4
- Development phase
- 54
- Enrollment target
NCT05319756: Completed Phase 4 study, sponsored by Viatris Specialty.
NCT05319756 is a Phase 4 study that has completed, run by Viatris Specialty. The registered enrollment target is 54 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05319756, a Phase 4 study, has completed, sponsored by Viatris Specialty.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 54 participants
- Enrollment target
Study Summary
This will be a randomized, double-blind, double-dummy, placebo- and active-controlled, 6 treatment, 6-period crossover single-dose, Williams square design study in healthy male and/or female adult, non-drug-dependent recreational opioid users.
Primary Outcome
Drug liking assesses how much a participant likes or dislikes a drug effect at the time the question ("at this moment, my liking this drug is") is being asked. It is scored using a 100 mm visual analogue scale (VAS), where 0 mm = "Strong Disliking", 50 mm = "Neither Like nor Dislike", and 100 mm = "Strong Liking"
Interventions
- DRUG gabapentin 600 mg
- DRUG gabapentin 1200 mg
- DRUG gabapentin 600 mg and oxycodone HCl 20 mg
- DRUG gabapentin 1200 mg and oxycodone HCl 20 mg
- DRUG oxycodone HCl 20 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2021-04-30 |
| Est. Completion | 2021-12-31 |
| Phase | Phase 4 |
What the finished NCT05319756 record still lists
NCT05319756 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 54 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 5 interventions - of which gabapentin 600 mg is the first listed.
NCT05319756 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05319756 about?
NCT05319756 is a clinical study titled "Study Evaluating the Abuse Potential of NEURONTIN® in Healthy Non-drug Dependent, Recreational Opioid Users". This will be a randomized, double-blind, double-dummy, placebo- and active-controlled, 6 treatment, 6-period crossover single-dose, Williams square design study in healthy male and/or female adult, non-drug-dependent recreational opioid users.
What is the current status of trial NCT05319756?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 54 participants. The study started on 2021-04-30. Estimated completion is 2021-12-31.
What interventions are being tested in trial NCT05319756?
The interventions under investigation include: gabapentin 600 mg (DRUG), gabapentin 1200 mg (DRUG), gabapentin 600 mg and oxycodone HCl 20 mg (DRUG), gabapentin 1200 mg and oxycodone HCl 20 mg (DRUG), oxycodone HCl 20 mg (DRUG).
Who is sponsoring clinical trial NCT05319756?
This trial is sponsored by Viatris Specialty, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05319756's enrollment target sits among peer trials
54 1223rd of 2000 higher than 772 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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