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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 is a Phase 4 study that has completed, run by Viatris Specialty. The registered enrollment target is 54 participants.

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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.

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

FieldValue
Enrollment Target 54 participants
Start Date 2021-04-30
Est. Completion 2021-12-31
Phase Phase 4

Sponsor

Viatris Specialty

5 total trials

What the Registry Record Tells You About NCT05319756

The ClinicalTrials.gov registry entry for NCT05319756 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 54 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Viatris Specialty, which has 5 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 5 interventions - of which gabapentin 600 mg is the first listed.

NCT05319756 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.