MedTrace Logo

Evaluating the Abuse Potential of NEURONTIN® When Taken Orally in Healthy Non-drug Dependent Participants With Sedative Drug Abuse Experience

NCT04570436 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2024-07-24

Study results available
· View outcomes & findings →

Summary

This will be a randomized, double-blind, double-dummy, placebo- and active controlled, 5 treatment, 10 sequence, 5 period crossover single dose, Williams square design study in healthy adult, non drug dependent male and female participants with drug abuse experience with sedative drugs.

Conditions

  • Abuse Potential

Interventions

DRUG

gabapentin 600 mg

participants will receive an oral dose of gabapentin 600 mg

DRUG

gabapentin 1200 mg

participants will receive an oral dose of gabapentin 1200 mg

DRUG

gabapentin 1800 mg

participants will receive an oral dose of gabapentin 1800 mg

DRUG

diazepam 20 mg

participants will receive an oral dose of 20 mg dose of diazepam

OTHER

placebo

participants will receive an oral dose of placebo

Sponsors & Collaborators

  • Viatris Specialty LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2021-03-29
Primary Completion
2022-11-10
Completion
2022-11-10
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT04570436 on ClinicalTrials.gov