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An Abuse Potential Study of Orally Administered HORIZANT in Healthy, Non-dependent, Recreational Drug Users

NCT06097676 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2024-08-12

Study results available
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Summary

The purpose of this study is to assess the abuse potential of gabapentin enacarbil in healthy adult, non-dependent, recreational drug users.

Conditions

  • Abuse Potential

Interventions

DRUG

Placebo

Placebo

DRUG

Alprazolam 2 mg

Oral dose of alprazolam 2 mg

DRUG

Gabapentin Enacarbil Immediate Release (GE-IR) 200 mg

Oral dose of GE-IR 200 mg

DRUG

Gabapentin Enacarbil Immediate Release (GE-IR) 450 mg

Oral dose of GE-IR 450 mg

DRUG

Gabapentin Enacarbil Immediate Release (GE-IR) 700 mg

Oral dose of GE-IR 700 mg

Sponsors & Collaborators

  • Arbor Pharmaceuticals, Inc.

    lead INDUSTRY

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
2021-09-28
Primary Completion
2022-06-30
Completion
2022-06-30
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 NCT06097676 on ClinicalTrials.gov