Does gabapentin make oxycodone more likable? a trial asks
NCT ID NCT07813026
First seen Sep 10, 2026 · Last updated Sep 11, 2026 · Updated 1 time
Summary
Researchers are studying whether gabapentin, a drug used for nerve pain and seizures, changes how much people like the effects of oxycodone, a prescription opioid. The trial enrolls healthy adults aged 18 to 55 who have used opioids recreationally but are not dependent on drugs. In a six-way crossover design, participants receive single doses of placebo, oxycodone alone, gabapentin alone at two doses, and gabapentin combined with oxycodone, then rate their drug liking on a visual scale.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- gabapentin, alone and combined with oxycodone
- What this could lead to
- If gabapentin raises the abuse potential of oxycodone, regulators and doctors could tighten prescribing advice for the combination. If it does not, the findings could ease concerns about mixing the two drugs.
- What could go wrong
- The study is small, with about 60 participants, and tests single doses in healthy recreational opioid users. Its results may not reflect how people who take these drugs long-term for pain respond.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2026
- Expected to finish
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Feb 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 55 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Male and female participants must be 18 to 55 years of age, inclusive, at the time of screening. Participants must meet reproductive criteria as outlined in the protocol. 2. Male and female participants who are overtly healthy. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, complete physical examination, vital signs, 12-lead ECG, and/or clinical laboratory tests. 3. Participants must have drug abuse experience with opioids; ie, must have used opioids for non-therapeutic purposes (ie, for psychoactive effects) on at least 10 occasions within the last year and at least once in the 12 weeks before the Screening Visit (Visit 1). 4. Participants must satisfactorily complete both the Naloxone Challenge and the Drug Discrimination. 5. Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures. 6. Body mass index (BMI) of 17.5 to 34 kg/m2, inclusive; and a total body weight ≥50 kg (110 lb). 7. Capable of giving signed informed consent as described in the protocol, which includes compliance with the requirements and restrictions listed in the informed consent document (ICD) and in this protocol. Exclusion Criteria: 1. Participants with current or past diagnosis of any type of drug dependence within the past year. Diagnosis of substance and/or alcohol dependence (excluding caffeine and nicotine) will be assessed by the Investigator using the Diagnostic and Statistical Manual 5-Text Revision (DSM 5-TR) criteria performed at Screening. Current drug use will be allowed if the candidate can produce a negative urine sample excluding tetrahydrocannabinol (THC) prior to first dose and are free of any signs/symptoms of withdrawal. The candidate will be informed if they have a positive breathalyzer test or urine ethanol test. 2. Participants who are heavy smokers (\>20 cigarettes equivalents per day). 3. Participants who are unable to abstain from smoking for at least 2 hours before and at least 8 hours after study drug administration. 4. Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing). 5. Patients with any history of sleep apnea, myasthenia gravis and glaucoma. 6. Any condition or surgery possibly affecting drug absorption (e.g., gastrectomy) excluding cholecystectomy. 7. Abnormal baseline end-tidal carbon dioxide (EtCO2) \<35mm Hg or \>45 mm Hg. 8. Participants with a positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibody (HCVab). 9. Participants with active suicidal ideation or suicidal behavior within 5 years prior to Screening as determined through the use of the Columbia Suicide Severity Rating Scale (C SSRS) or active ideation identified at Screening or on Day -1. 10. Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study. 11. Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half lives (whichever is longer) prior to the first dose of investigational product. (Refer to Section 6.8 for additional details). 12. Herbal supplements and herbal medications must be discontinued at least 14 days prior to the first dose of study medication. 13. Previous administration with an investigational drug within 30 days (or as determined by the local requirement) or 5 half lives (whichever is longer) prior to screening. 14. Positive urine drug screen (UDS) for substances of abuse at admission to the Qualification Phase, excluding tetrahydrocannabinol (THC). 15. Participants who are unable to abstain from using THC during the inpatient stays in the Qualification and Treatment Phases of the study. 16. Has participated in, is currently participating in, or is seeking treatment for substance and/or alcohol related disorders (excluding nicotine and caffeine). If participation in a rehabilitation program was court-mandated as part of a plea agreement, entry may be permissible at the Investigator's discretion. 17. Has a positive urine ethanol test at Screening or upon admission to the study center. 18. Screening sitting blood pressure (BP) ≥145 mm Hg (systolic) or ≥95 mm Hg (diastolic), following at least 5 minutes rest. 19. Baseline (screening) 12 lead ECG that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results. 20. Participants with abnormalities in clinical laboratory tests for liver function tests at screening if deemed to be clinically significant in the opinion of the investigator. 21. Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 56 days prior to dosing. 22. History of sensitivity to heparin or heparin induced thrombocytopenia. 23. History of hypersensitivity to gabapentin or oxycodone or any of the components in the formulation of the study products.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Dr. Vince Clinical Research
RECRUITINGOverland Park, Kansas, 66212, United States