HealthyPhase 4NCT07813026
Abuse Potential of Gabapentin Taken Orally Concomitantly With Oxycodone Hydrochloride in Healthy, Non-Drug-Dependent, Recreational Opioid Users
A Phase 4 study testing Oxycodone 20mg, gabapentin 600 mg and Gabapentin 1200mg in people with Healthy, run by Viatris Inc. at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Oxycodone 20mg, gabapentin 600 mg and Gabapentin 1200mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Aug 2026to 14 Feb 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
- 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.
- 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).
- Participants must satisfactorily complete both the Naloxone Challenge and the Drug Discrimination.
- 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).
- 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.
Who cannot join
- 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.
- Participants who are heavy smokers (>20 cigarettes equivalents per day).
- Participants who are unable to abstain from smoking for at least 2 hours before and at least 8 hours after study drug administration.
- 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).
- Patients with any history of sleep apnea, myasthenia gravis and glaucoma.
- Any condition or surgery possibly affecting drug absorption (e.g., gastrectomy) excluding cholecystectomy.
Show all 23Show fewer
- Abnormal baseline end-tidal carbon dioxide (EtCO2) <35mm Hg or >45 mm Hg.
- Participants with a positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibody (HCVab).
- 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.
- 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.
- 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).
- Herbal supplements and herbal medications must be discontinued at least 14 days prior to the first dose of study medication.
- 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.
- Positive urine drug screen (UDS) for substances of abuse at admission to the Qualification Phase, excluding tetrahydrocannabinol (THC).
- Participants who are unable to abstain from using THC during the inpatient stays in the Qualification and Treatment Phases of the study.
- 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.
- Has a positive urine ethanol test at Screening or upon admission to the study center.
- Screening sitting blood pressure (BP) ≥145 mm Hg (systolic) or ≥95 mm Hg (diastolic), following at least 5 minutes rest.
- Baseline (screening) 12 lead ECG that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results.
- 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.
- Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 56 days prior to dosing.
- History of sensitivity to heparin or heparin induced thrombocytopenia.
- History of hypersensitivity to gabapentin or oxycodone or any of the components in the formulation of the study products.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Dr. Vince Clinical Research
Overland Park, Kansas, 66212
William Lavery, (913) 333-3000, wlavery@drvince.com
About this study
Official title: A Phase 4, Randomized, Double-Blind, Placebo and Active-Controlled, Single-Dose, Six-Way Crossover Study Evaluating the Abuse Potential of Gabapentin Taken Orally Concomitantly With Oxycodone Hydrochloride in Healthy, Non-Drug- Dependent, Recreational Opioid Users
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.
Read the detailed description
This study consists of a Screening Visit (Visit 1), followed within 28 days by a Qualification Phase (Visit 2) which will require inpatient stay at the clinical research unit (CRU) for 3 nights. After a washout of at least 4 days, eligible participants will enter the Treatment Phase which will include 6 treatment periods with each dosing day separated by a washout period of at least 4 days. Participants will remain residential at the CRU from admission to the Qualification Phase through to completion of the assessments of the last treatment period in the Treatment Phase (approximately 28 days). A follow-up visit (Visit 3) will be scheduled from 7 to 14 days after the administration of the final dose of investigational product.
- Conditions
- Healthy
- Being tested
- Placebo, Oxycodone 20mg, gabapentin 600 mg, Gabapentin 1200mg, Gabapentin 600 mg + Oxycodone 20 mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Placebo
Oxycodone 20mgDrug
oxycodone 20mg
gabapentin 600 mgDrug
Gabapentin 600 mg
Gabapentin 1200mgDrug
Gabapentin 1200mg
Gabapentin 600 mg + Oxycodone 20 mgDrug
Gabapentin 600 mg + Oxycodone 20 mg
Gabapentin 1200 mg + Oxycodone 20 mgDrug
Gabapentin 1200 mg + Oxycodone 20 mg
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Oxycodone 20mg | Active comparator | Not described Receives: Drug: Oxycodone 20mg |
| Gabapentin 600mg | Active comparator | Not described Receives: Drug: gabapentin 600 mg |
| Gabapentin 1200mg | Active comparator | Not described Receives: Drug: Gabapentin 1200mg |
| Gabapentin 600mg with Oxycodone 20mg | Active comparator | Not described Receives: Drug: Gabapentin 600 mg + Oxycodone 20 mg |
| Gabapentin 1200mg with Oxycodone 20mg | Active comparator | Not described Receives: Drug: Gabapentin 1200 mg + Oxycodone 20 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bipolar Visual Analog Scale (VAS) for "Drug Liking" Maximum Effect (Emax)
Drug Liking assesses how much a participant likes or dislikes a drug effect at the time the question is being asked. It is scored using a 100 mm visual analogue scale (VAS), where 0 mm = "Strong Disliking", 50 mm = "Neither Like nor Dislike", and 100 mm = "Strong Liking"
Measured: Up to 24 hours after treatments
Secondary outcomes (8)
Bipolar VAS for "Drug Liking" (Time for Emax [TEmax])
Time after dosing when the maximum effect for Drug Liking VAS is reached
Measured: Up to 24 hours after treatments
Bipolar VAS for "Drug Liking" (Area Under the Effect-time Profile From Time 0 to the Time of the Last Quantifiable Effect [AUEClast])
Area under the effect-time profile from time 0 to the time of the last available data for the "Drug liking" visual analog scale which assesses how much a participant likes or dislikes a drug effect at the time the question ("at this moment, my liking this drug is") is being asked. It is scored using a 100 mm visual analogue scale (VAS), where 0 mm = "Strong Disliking", 50 mm = "Neither Like nor Dislike", and 100 mm = "Strong Liking". The minimum and maximum possible scores are approximately 0 and 2400 if a subject scores 0 mm (strong disliking) and 100 mm (strong liking) respectively at every timepoint up to 24 hours.
Measured: Up to 24 hours after treatments (Assessments were made at the following timepoints after each treatment: 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12 and 24hours)
Unipolar VAS for "High" (Maximum Effect, Emax)
Maximum effect on the 100 mm visual analog scale for the question "I am feeling high" where 0 = "not at all" and 100 = "extremely"
Measured: Up to 24 hours after treatments
Unipolar VAS for "High" (Time for Emax [TEmax])
Time after dosing when the maximum effect for "High" VAS is reached
Measured: Up to 24 hours after treatments
Unipolar VAS for "High" (Area Under the Effect-time Profile From Time 0 to the Time of the Last Quantifiable Effect [AUEClast])
Area under the effect-time profile from time 0 to the time of the last available data for the "High" visual analog scale which measures on a 100 mm visual analog scale the subject's response to the question "I am feeling high" where 0
= "not at all" and 100 = "extremely". The minimum and maximum possible scores are 0 and approximately 2400 if a subject scores 0 mm (not at all) and 100 mm (extremely) respectively at every timepoint up to 24 hours.
Measured: Up to 24 hours after treatments (Assessments were made at the following timepoints after each treatment: 0, 0.25, 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12 and 24 hours)
Bipolar VAS for "Take Drug Again"
100 mm visual analog scale for the question "I would take this drug again" where 0 = "definitely not", 50 = "neutral", and 100 = "definitely so".
Measured: at 12 and 24 hours after treatments
Bipolar VAS for "Overall Drug Liking"
100 mm visual analog scale for the question "Overall, my liking for this drug is" where 0 = "definitely not", 50 = "neutral", and 100 = "definitely so".
Measured: at 12 and 24 hours after treatments
Pupil size (diameter) change for baseline from Maximum Effect
Measured: Up to 24 hours after treatments (Assessments were made at the following timepoints after each treatment: 0, 0.25, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12 and 24 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2026
- Study start3 Aug 2026
- Primary completion31 Jan 2027 (estimated)
- Study completion14 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Viatris Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Dr. Vince Clinical Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07813026
- Sponsor's protocol ID
- GABA-TBZ-4001
- Status last verified
- Oct 2026
- First submitted
- 4 Sep 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 4, Randomized, Double-Blind, Placebo and Active-Controlled, Single-Dose, Six-Way Crossover Study Evaluating the Abuse Potential of Gabapentin Taken Orally Concomitantly With Oxycodone Hydrochloride in Healthy, Non-Drug- Dependent, Recreational Opioid Users
- ClinicalTrials.gov ID
- NCT07813026
- Acronym / sponsor ID
- GABA-TBZ-4001
- Conditions
- Healthy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Viatris Inc.Industry (pharma, biotech, devices)
- Collaborators
- Dr. Vince Clinical Research
- Study start
- 3 Aug 2026 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 14 Feb 2027 (estimated)
- First posted
- 10 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study consists of a Screening Visit (Visit 1), followed within 28 days by a Qualification Phase (Visit 2) which will require inpatient stay at the clinical research unit (CRU) for 3 nights. After a washout of at least 4 days, eligible participants will enter the Treatment Phase which will include 6 treatment periods with each dosing day separated by a washout period of at least 4 days. Participants will remain residential at the CRU from admission to the Qualification Phase through to completion of the assessments of the last treatment period in the Treatment Phase (approximately 28 days). A follow-up visit (Visit 3) will be scheduled from 7 to 14 days after the administration of the final dose of investigational product.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| Oxycodone 20mg | Active comparator | Drug: Oxycodone 20mg |
| Gabapentin 600mg | Active comparator | Drug: gabapentin 600 mg |
| Gabapentin 1200mg | Active comparator | Drug: Gabapentin 1200mg |
| Gabapentin 600mg with Oxycodone 20mg | Active comparator | Drug: Gabapentin 600 mg + Oxycodone 20 mg |
| Gabapentin 1200mg with Oxycodone 20mg | Active comparator | Drug: Gabapentin 1200 mg + Oxycodone 20 mg |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
- 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.
- 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).
- Participants must satisfactorily complete both the Naloxone Challenge and the Drug Discrimination.
- Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
Key exclusion criteria (23 listed)
- 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.
- Participants who are heavy smokers (>20 cigarettes equivalents per day).
- Participants who are unable to abstain from smoking for at least 2 hours before and at least 8 hours after study drug administration.
- 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).
- Patients with any history of sleep apnea, myasthenia gravis and glaucoma.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboPlacebo | Drug | Placebo |
| Oxycodone 20mgoxycodone 20mg | Drug | Oxycodone 20mg |
| gabapentin 600 mgGabapentin 600 mg | Drug | Gabapentin 600mg |
| Gabapentin 1200mgGabapentin 1200mg | Drug | Gabapentin 1200mg |
| Gabapentin 600 mg + Oxycodone 20 mgGabapentin 600 mg + Oxycodone 20 mg | Drug | Gabapentin 600mg with Oxycodone 20mg |
| Gabapentin 1200 mg + Oxycodone 20 mgGabapentin 1200 mg + Oxycodone 20 mg | Drug | Gabapentin 1200mg with Oxycodone 20mg |
Primary outcome
Bipolar Visual Analog Scale (VAS) for "Drug Liking" Maximum Effect (Emax)
Time frame: Up to 24 hours after treatments
Drug Liking assesses how much a participant likes or dislikes a drug effect at the time the question is being asked. It is scored using a 100 mm visual analogue scale (VAS), where 0 mm = "Strong Disliking", 50 mm = "Neither Like nor Dislike", and 100 mm = "Strong Liking"
8 secondary outcomes
Bipolar VAS for "Drug Liking" (Time for Emax [TEmax])
Time frame: Up to 24 hours after treatments
Bipolar VAS for "Drug Liking" (Area Under the Effect-time Profile From Time 0 to the Time of the Last Quantifiable Effect [AUEClast])
Time frame: Up to 24 hours after treatments (Assessments were made at the following timepoints after each treatment: 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12 and 24hours)
Unipolar VAS for "High" (Maximum Effect, Emax)
Time frame: Up to 24 hours after treatments
Unipolar VAS for "High" (Time for Emax [TEmax])
Time frame: Up to 24 hours after treatments
Unipolar VAS for "High" (Area Under the Effect-time Profile From Time 0 to the Time of the Last Quantifiable Effect [AUEClast])
Time frame: Up to 24 hours after treatments (Assessments were made at the following timepoints after each treatment: 0, 0.25, 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12 and 24 hours)
Bipolar VAS for "Take Drug Again"
Time frame: at 12 and 24 hours after treatments
Bipolar VAS for "Overall Drug Liking"
Time frame: at 12 and 24 hours after treatments
Pupil size (diameter) change for baseline from Maximum Effect
Time frame: Up to 24 hours after treatments (Assessments were made at the following timepoints after each treatment: 0, 0.25, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12 and 24 hours)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Oxycodone 20mg, gabapentin 600 mg and Gabapentin 1200mg in people with Healthy, run by Viatris Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dik Ng ((+44) 1304626895, Dik.Ng@viatris.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bipolar Visual Analog Scale (VAS) for "Drug Liking" Maximum Effect (Emax) (time frame: Up to 24 hours after treatments). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.