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Study Evaluating the Abuse Potential of NEURONTIN® in Healthy Non-drug Dependent, Recreational Opioid Users

NCT05319756 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2023-08-14

Study results available
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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.

Conditions

  • Abuse Potential

Interventions

DRUG

gabapentin 600 mg

Participants will receive a single oral dose of gabapentin 600 mg and a placebo that looks like oxycodone HCl

DRUG

gabapentin 1200 mg

Participants will receive a single oral dose of gabapentin 1200 mg and a placebo that looks like oxycodone HCl

DRUG

gabapentin 600 mg and oxycodone HCl 20 mg

Participants will receive a single oral dose of gabapentin 600 mg and oxycodone HCl 20 mg

DRUG

gabapentin 1200 mg and oxycodone HCl 20 mg

Participants will receive a single oral dose of gabapentin 1200 mg and oxycodone HCl 20 mg

DRUG

oxycodone HCl 20 mg

Participants will receive a single oral dose of oxycodone HCl 20 mg and a placebo that looks like gabapentin

DRUG

placebo

Participants will receive a single oral dose of a placebo that looks like gabapentin and a placebo that looks like oxycodone HCl

Sponsors & Collaborators

  • Viatris Specialty LLC

    lead INDUSTRY

Principal Investigators

  • Dik WH NG, PhD · Viatris Inc.

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-04-30
Primary Completion
2021-12-31
Completion
2021-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05319756 on ClinicalTrials.gov