Search > Recreational Opioid Use
60 Participants NeededMy employer runs this trial

Gabapentin + Oxycodone for Recreational Opioid Use

DN
Overseen ByDik Ng
Age: 18 - 65
Sex: Any
Trial Phase: Phase 4
Sponsor: Viatris Inc.
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

This trial is for healthy adults who occasionally use opioids recreationally but are not dependent on drugs. Participants must be in good health and able to safely take the study medications.

Inclusion Criteria

Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures
Body mass index (BMI) of 17.5 to 34 kg/m2, inclusive, and a total body weight ≥50 kg (110 lb)
Participants must have drug abuse experience with opioids, having used opioids for non-therapeutic purposes on at least 10 occasions within the last year and at least once in the 12 weeks before the Screening Visit
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Exclusion Criteria

Active suicidal ideation or behavior within 5 years prior to Screening or active ideation at Screening or Day -1
Baseline 12 lead ECG with clinically relevant abnormalities affecting safety or study interpretation
Abnormal baseline end-tidal carbon dioxide (EtCO2) <35 mm Hg or >45 mm Hg
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What Are the Treatments Tested in This Trial?

Interventions

  • Gabapentin
  • Oxycodone

Trial Overview

The study tests how likely people are to misuse gabapentin alone, oxycodone alone, or both together compared to a placebo. Different doses of gabapentin (600mg and 1200mg) with or without oxycodone (20mg) are given by mouth under controlled conditions.

How Is the Trial Designed?

6

Treatment groups

Active Control

Placebo Group

Group I: Treatment Phase BActive Control1 Intervention
Group II: Treatment Phase CActive Control1 Intervention
Group III: Treatment Phase DActive Control1 Intervention
Group IV: Treatment Phase EActive Control1 Intervention
Group V: Treatment Phase FActive Control1 Intervention
Group VI: Treatment Phase APlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Viatris Inc.

Lead Sponsor

Trials
11
Recruited
5,600+

Dr. Vince Clinical Research

Collaborator

Trials
3
Recruited
80+

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