Abuse Potential of Gabapentin Taken Orally Concomitantly With Oxycodone Hydrochloride in Healthy, Non-Drug-Dependent, Recreational Opioid Users

Part of paid clinical trials in Overland Park, Kansas.

Sponsor
Viatris Inc.
Study ID
NCT07813026
Phase
PHASE4
Status
Recruiting

Conditions

  • Healthy, Non-Drug- Dependent, Recreational Opioid Users

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Placebo — DRUG
    Placebo
  • Oxycodone 20mg — DRUG
    oxycodone 20mg
  • gabapentin 600 mg — DRUG
    Gabapentin 600 mg
  • Gabapentin 1200mg — DRUG
    Gabapentin 1200mg
  • Gabapentin 600 mg + Oxycodone 20 mg — DRUG
    Gabapentin 600 mg + Oxycodone 20 mg
  • Gabapentin 1200 mg + Oxycodone 20 mg — DRUG
    Gabapentin 1200 mg + Oxycodone 20 mg

Study Details

The purpose of the present study is to assess prospectively the abuse potential of gabapentin when taken with and without oxycodone compared to placebo in healthy non-drug-dependent recreational opioid drug users under fasted condition.

Key Dates

First listed
Sep 10, 2026
Start date
Aug 3, 2026
Status verified
Sep 2026
Primary completion
Jan 31, 2027
Completion
Feb 14, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER

Arms

  • Placebo Comparator: Treatment Phase A
  • Active Comparator: Treatment Phase B
  • Active Comparator: Treatment Phase C
  • Active Comparator: Treatment Phase D
  • Active Comparator: Treatment Phase E
  • Active Comparator: Treatment Phase F

Primary Outcome Measure

Bipolar Visual Analog Scale (VAS) for "Drug Liking" Maximum Effect (Emax) [ Time Frame: Up to 24 hours after treatments ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Dr. Vince Clinical ResearchOverland ParkKansas66212
William Lavery
(913) 333-3000

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