This will be a randomized, double-blind, double-dummy, placebo- and active controlled, 5 treatment, 10 sequence, 5 period crossover single dose, Williams square design study in healthy adult, non drug dependent male and female participants with drug abuse experience with sedative drugs.
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, double dummy, placebo- and active controlled, 5 treatment, 10-sequence, 5 period crossover, single-dose, Williams square design study in healthy male and/or female adult, non drug-dependent recreational users. On Day 1 of each of the Treatment Phase 5 periods, which will be separated by a washout of at least 14 days, participants will receive an oral dose of either NEURONTIN® 1800 mg, 1200 mg or 600 mg or 20 mg diazepam, 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 until 1 hour prior to dosing and 1 hour after dosing.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
52
participants will receive an oral dose of gabapentin 600 mg
participants will receive an oral dose of gabapentin 1200 mg
participants will receive an oral dose of gabapentin 1800 mg
Pharmaceutical Research Associates, Inc.
Salt Lake City, Utah, 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 72 hours after treatments
Bipolar VAS for "Drug Liking" (Time for Maximum Effect, Emax [TEmax])
Time after dosing when the maximum effect for Drug Liking VAS is reached
Time frame: up to 72 hours after treatments
Bipolar VAS for "Drug Liking" (Area Under the Effect-time Profile From Time 0 to the Time of the Last Quantifiable Concentration [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 7200 if a subject scores 0 mm (strong disliking) and 100 mm (strong liking) respectively at every timepoint up to 72 hours.
Time frame: Up to 72 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, 24, 36, 48, and 72 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 72 hours after treatments
Unipolar VAS for "High" (Time for Maximum Effect, Emax [TEmax])
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participants will receive an oral dose of 20 mg dose of diazepam
participants will receive an oral dose of placebo
Time after dosing when the maximum effect for "High" VAS is reached
Time frame: up to 72 hours after treatments
Unipolar VAS for "High" (Area Under the Effect-time Profile From Time 0 to the Time of the Last Quantifiable Concentration [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 7200 if a subject scores 0 mm (not at all) and 100 mm (extremely) respectively at every timepoint up to 72 hours.
Time frame: Up to 72 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, 24, 36, 48, and 72 hours)
Bipolar VAS for "Take Drug Again" at 24 Hour Post Dose
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 24 hours after treatment
Bipolar VAS for "Take Drug Again" at 36 Hour Post Dose
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 36 hours after treatment
Bipolar VAS for "Take Drug Again" at 48 Hour Post Dose
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 48 hours after treatment
Bipolar VAS for "Take Drug Again" at 72 Hour Post Dose
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 72 hours after treatment
Bipolar VAS for "Overall Drug Liking" at 24 Hour Post Dose
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 24 hours after treatment
Bipolar VAS for "Overall Drug Liking" at 36 Hour Post Dose
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 36 hours after treatment
Bipolar VAS for "Overall Drug Liking" at 48 Hour Post Dose
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 48 hours after treatment
Bipolar VAS for "Overall Drug Liking" at 72 Hour Post Dose
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 72 hours after treatment
Cmax of Gabapentin
Maximum plasma concentration (Cmax) of gabapentin
Time frame: Up to 72 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, 24, 36, 48, and 72 hours)
Tmax of Gabapentin
Time when the maximum concentration of gabapentin is reached
Time frame: Up to 72 hours after treatments (concentrations were measured at the following timepoints after each treatment for thisoutcome measure: 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48 and 72 hours)
AUClast of Gabapentin
Area under the effect time profile from time 0 to the time of the last quantifiable concentration (AUClast) of gabapentin
Time frame: up to 72 hours after treatment (concentrations were measured at the following timepoints after each treatment for thisoutcome measure: 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48 and 72 hours)
Terminal Half-life of Gabapentin
Terminal half-life (t½) of gabapentin
Time frame: up to 72 hours after treatment (concentrations were measured at the following timepoints after each treatment for thisoutcome measure: 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48 and 72 hours)