The purpose of the present study is to assess prospectively the abuse potential of gabapentin compared to placebo and alprazolam in healthy non-drug-dependent recreational sedative drug users under fasted condition.
The study includes Screening, a Qualification Phase consisting of a Naloxone Challenge and Drug Discrimination crossover study, a Treatment Phase and Follow-up. Following successful completion of the Qualification Phase the participants will be enrolled in the Treatment phase. The Treatment Phase is a randomized, double-blind, placebo- and active-controlled, 4 period crossover, single-dose, Williams square design study in healthy male and female adult, non-dependent, recreational sedative users. On Day 1 of each of the Treatment Phase 4 periods, which will be separated by a washout of at least 6 days, participants will receive an oral dose of either gabapentin 1800 mg or 1200 mg or 2 mg alprazolam, or placebo. Study treatments will be administered under fasted conditions (overnight fast and no food until 4 hours after dosing). Water will be allowed without restriction except from 1 hour prior to dosing until 1 hour after dosing.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
44
Dr. Vince Clinical Research
Overland Park, Kansas, United States
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"
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 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"
Time frame: Up to 24 hours after treatments
Unipolar VAS for "High" (Time for Emax [TEmax])
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1800mg
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" where0 = "definitely not", 50 = "neutral", and 100 = "definitely so".
Time frame: at 12 and 24 hours after treatments
Pharmacokinetics of gabapentin
Maximum plasma concentration (Cmax), time when the maximum concentration is reached (Tmax), and Area Under the concentration time profile from time 0 to the time of the last quantifiable concentration (AUClast) for gabapentin measured from blood samples
Time frame: Up to 24 hours after treatments (concentrations were measured at the following timepoints after each treatment for this outcome measure: 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12 and 24hours)