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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
60
Dr. Vince Clinical Research
Overland Park, Kansas, United States
RECRUITINGBipolar 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"
Time frame: Up to 24 hours after treatments
Bipolar VAS for "Drug Liking" (Time for Emax [TEmax])
Time after dosing when the maximum effect for Drug Liking VAS is reached
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])
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.
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)
Maximum effect on the 100 mm visual analog scale for the question "I am feeling high" where 0 = "not at all" and 100 = "extremely"
Time frame: Up to 24 hours after treatments
Unipolar VAS for "High" (Time for Emax [TEmax])
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Gabapentin 1200mg
Gabapentin 600 mg + Oxycodone 20 mg
Gabapentin 1200 mg + Oxycodone 20 mg
Time after dosing when the maximum effect for "High" VAS is reached
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])
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.
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"
100 mm visual analog scale for the question "I would take this drug again" where 0 = "definitely not", 50 = "neutral", and 100 = "definitely so".
Time frame: 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".
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)