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

NCT07813026 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: GABA-TBZ-4001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy, Non-Drug- Dependent, Recreational Opioid Users

Outcome Measures

Primary Outcomes (1)

• 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"

  Up to 24 hours after treatments

Secondary Outcomes (8)

• Bipolar VAS for "Drug Liking" (Time for Emax [TEmax])

  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])

  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)

  Up to 24 hours after treatments

• Unipolar VAS for "High" (Time for Emax [TEmax])

  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])

  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)

Study Arms (6)

Treatment Phase A

PLACEBO COMPARATOR

Drug: Placebo

Treatment Phase B

ACTIVE COMPARATOR

Drug: Oxycodone 20mg

Treatment Phase C

ACTIVE COMPARATOR

Drug: gabapentin 600 mg

Treatment Phase D

ACTIVE COMPARATOR

Drug: Gabapentin 1200mg

Treatment Phase E

ACTIVE COMPARATOR

Drug: Gabapentin 600 mg + Oxycodone 20 mg

Treatment Phase F

ACTIVE COMPARATOR

Drug: Gabapentin 1200 mg + Oxycodone 20 mg

Interventions

Gabapentin 1200mg DRUG

Gabapentin 1200mg

Treatment Phase D

Gabapentin 1200 mg + Oxycodone 20 mg DRUG

Gabapentin 1200 mg + Oxycodone 20 mg

Treatment Phase F

Placebo DRUG

Placebo

Treatment Phase A

Oxycodone 20mg DRUG

oxycodone 20mg

Treatment Phase B

gabapentin 600 mg DRUG

Gabapentin 600 mg

Treatment Phase C

Gabapentin 600 mg + Oxycodone 20 mg DRUG

Gabapentin 600 mg + Oxycodone 20 mg

Treatment Phase E

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Viatris Inc.: lead
• Dr. Vince Clinical Research: collaborator

Study Sites (1)

Dr. Vince Clinical Research

Overland Park, Kansas, 66212, United States

RECRUITING

MeSH Terms

Interventions

Oxycodone; Gabapentin

Intervention Hierarchy (Ancestors)

Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins

Central Study Contacts

Dik Ng

CONTACT

(+44) 1304626895; Dik.Ng@viatris.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2026
• First Posted: September 10, 2026
• Study Start: August 3, 2026
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): February 14, 2027
• Last Updated: September 10, 2026

Record last verified: 2026-09

Locations

US (1)