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.
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 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).
Crossover
Placebo
DrugPlacebo
Oxycodone 20mg
Drugoxycodone 20mg
gabapentin 600 mg
DrugGabapentin 600 mg
Gabapentin 1200mg
DrugGabapentin 1200mg
Gabapentin 600 mg + Oxycodone 20 mg
DrugGabapentin 600 mg + Oxycodone 20 mg
Gabapentin 1200 mg + Oxycodone 20 mg
DrugGabapentin 1200 mg + Oxycodone 20 mg
6
Treatment groupsSee each treatment group below.
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"
Bipolar VAS for "Drug Liking" (Time for Emax [TEmax])
Time after dosing when the maximum effect for Drug Liking VAS is reached
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.
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"
Unipolar VAS for "High" (Time for Emax [TEmax])
Time after dosing when the maximum effect for "High" VAS is reached
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Viatris Inc.
Lead sponsor
Dr. Vince Clinical Research
Collaborator
