Study Evaluating the Abuse Potential of NEURONTIN® in Hea... | NCT05319756

Label	Type	Intervention Names
gabapentin 600 mg single dose	Experimental	Drug: gabapentin 600 mg
gabapentin 1200 mg single dose	Experimental	Drug: gabapentin 1200 mg
gabapentin 600 mg and oxycodone HCl 20 mg	Experimental	Drug: gabapentin 600 mg and oxycodone HCl 20 mg
gabapentin 1200 mg and oxycodone HCl 20 mg	Experimental	Drug: gabapentin 1200 mg and oxycodone HCl 20 mg
oxycodone HCl 20 mg single dose	Active Comparator	Drug: oxycodone HCl 20 mg
placebo single dose	Placebo Comparator	Drug: placebo

Name	Type	Description	Arm Group Labels	Other Names
gabapentin 600 mg	Drug	Participants will receive a single oral dose of gabapentin 600 mg and a placebo that looks like oxycodone HCl	gabapentin 600 mg single dose

Measure	Description	Time Frame
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 ("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"	up to 48 hours after treatments

Measure	Description	Time Frame
Bipolar VAS for "Drug Liking" - Time to Maximum Effect (TEmax)	Time after dosing when the maximum effect for Drug Liking VAS is reached	up to 48 hours after treatments
Bipolar VAS for "Drug Liking": Area Under the Effect Curve From Time 0 to the Last Available Data (AUEClast)

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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 8 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.

Exclusion Criteria:

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 of Mental Disorders-IV (DSM-IV) criteria performed at Screening. Current drug use will be allowed if the candidate can produce a negative urine sample and are free of any signs/symptoms of withdrawal. The candidate will be informed if they have a positive breathalyzer test.
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).
Any condition possibly affecting drug absorption (eg, gastrectomy) excluding cholecystectomy within 1 year prior to study.
Abnormal baseline EtCO2 <35mm Hg or >45 mm Hg.
Clinical or laboratory evidence of active hepatitis A infection or a history of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C, and/or positive testing for HIV, hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), 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 0.
Participants with any history of sleep apnea, myasthenia gravis or glaucoma.
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 6.5 for additional details).
Herbal supplements, herbal medications and hormone replacement therapy must be discontinued at least 28 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) preceding the first dose of investigational product used in this study.
Positive urine drug screen (UDS) for substances of abuse at each admission in Qualification and Treatment Phase, excluding tetrahydrocannabinol (THC). If a participant presents with a positive UDS excluding THC at any admission or any visit, the investigator, at his/her discretion, may reschedule a repeat of UDS until the UDS is negative, excluding THC, before the participate is permitted to participate in any phase of the study.
Unable to abstain from using THC during the Qualification and Treatment Phase of the study.
Has participated in, is currently participating in, or is seeking treatment for substance and/or alcohol related disorders (excluding nicotine and caffeine).
Has a positive alcohol breathalyzer or urine test at each admission to the study center during Qualification and Treatment Phases. Positive results may be repeated and/or participants re scheduled at the Investigator's discretions.
Participants are heavy smokers or users of other types of nicotine products (>20 cigarettes equivalents per day).
Participants are unable to abstain from smoking for at least 2 hours before and at least 8 hours after study drug administration.
Screening sitting blood pressure (BP) >=140 mm Hg (systolic) or >=90 mm Hg (diastolic), following at least 5 minutes rest. If BP is >=140 mm Hg (systolic) or >=90 mm Hg (diastolic), the BP should be repeated 2 more times and the average of the 3 BP values should be used to determine the participant's eligibility. Repeated BP tests should be spaced at least 5 minutes apart.
Baseline (screening) 12 lead electrocardiogram (ECG) that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results (eg, baseline corrected QT (QTc) interval as determined by the Fridericia method (QTcF) >450 msec, complete left bundle branch block [LBBB], signs of an acute or indeterminate age myocardial infarction, ST T interval changes suggestive of myocardial ischemia, second or third degree atrioventricular [AV] block, or serious bradyarrhythmias or tachyarrhythmias). If the baseline uncorrected QT interval is >450 msec, this interval should be rate corrected using the Fridericia method and the resulting QTcF should be used for decision making and reporting. If QTcF exceeds 450 msec, or QRS exceeds 120 msec, the ECG should be repeated 2 more times and the average of the 3 QTcF or QRS values should be used to determine the participant's eligibility. Computer interpreted ECGs should be overread by a physician experienced in reading ECGs before excluding participants.
Participants with ANY of the following abnormalities in clinical laboratory tests at screening, as assessed by the study specific laboratory and confirmed by a single repeat test, if deemed necessary:
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level >=1.5 × upper limit of normal (ULN);
- Total bilirubin level >=1.5 × ULN; participants with a history of Gilbert's syndrome may have direct bilirubin measured and would be eligible for this study provided the direct bilirubin level is <= ULN.
Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 60 days prior to dosing.
History of sensitivity to heparin or heparin induced thrombocytopenia.
Unwilling or unable to comply with the criteria in the Lifestyle Considerations section of this protocol.
History of hypersensitivity to gabapentin or oxycodone or any of the components in the formulation of the study products.
Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or Sponsor employees, including their family members, directly involved in the conduct of the study.

Name	Affiliation	Role
Dik WH NG, PhD	Viatris Inc.	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Hassman Research Institute		Marlton	New Jersey	080503	United States

ID	Title	Description
FG000	Sequence 1	Period 1: Oxycodone 20 mg; Period 2: Placebo; Period 3: Gabapentin 1200 mg plus Oxycodone 20 mg; Period 4: Gabapentin 600 mg; Period 5: Gabapentin 600 mg plus Oxycodone 20 mg; Period 6: Gabapentin 1200 mg
FG001	Sequence 2

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Mar 12, 2021	Apr 14, 2023

ID	Title	Description
BG000	Randomized Population	All participants who were randomized to a treatment sequence in the Treatment Phase.

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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 ("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 analysis population was the modified completer population which included subjects who completed all 6 treatment periods but excluded those identified during data review as having maximum Drug Liking scores that were similar for all 6 treatments or who had high placebo responses

Posted

Mean

Standard Error

Score on a 100 mm scale

up to 48 hours after treatments

ID	Title	Description
OG000	Placebo	Participants received a single oral dose of a placebo that looks like gabapentin and a placebo that looks like oxycodone HCl
OG001	Oxycodone HCl 20 mg Single Dose	Participants received a single oral dose of oxycodone HCl 20 mg and a placebo that looks like gabapentin
OG002	Gabapentin 600 mg Single Dose	Participants received a single oral dose of gabapentin 600 mg and a placebo that looks like oxycodone HCl
OG003	Gabapentin 1200 mg Single Dose	Participants received a single oral dose of gabapentin 1200 mg and a placebo that looks like oxycodone HCl
OG004	Gabapentin 600 mg and Oxycodone HCl 20 mg	Participants received a single oral dose of gabapentin 600 mg and oxycodone HCl 20 mg
OG005	Gabapentin 1200 mg and Oxycodone HCl 20 mg	Participants received a single oral dose of gabapentin 1200 mg and oxycodone HCl 20 mg

Units	Counts
Participants	OG00042 OG00142 OG00242 OG003

Title

Denominators

Categories

Title	Measurements
	OG00054.89± 2.116 OG00187.40± 3.156 OG00257.89± 3.142 OG003

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	The sensitivity and integrity of the study was validated by comparing the mean responses of oxycodone HCl, the positive control (C), to the placebo (P): H0: μC - μP ≤ δ1 versus Ha: μC - μP > δ1 where δ1 =15	Mixed Models Analysis		<.0001		Mean Difference (Final Values)	32.8	Standard Error of the Mean	4.00	1-Sided	95	26.1						Superiority

Secondary

Bipolar VAS for "Drug Liking" - Time to Maximum Effect (TEmax)

Time after dosing when the maximum effect for Drug Liking VAS is reached

Modified completer population

Posted

Median

Full Range

hours

up to 48 hours after treatments

ID	Title	Description
OG000	Placebo Single Dose	placebo: Participants will receive a single oral dose of a placebo that looks like gabapentin and a placebo that looks like oxycodone HCl
OG001	Oxycodone HCl 20 mg Single Dose	oxycodone HCl 20 mg: Participants will receive a single oral dose of oxycodone HCl 20 mg and a placebo that looks like gabapentin
OG002	Gabapentin 600 mg Single Dose	gabapentin 600 mg: Participants will receive a single oral dose of gabapentin 600 mg and a placebo that looks like oxycodone HCl
OG003	Gabapentin 1200 mg Single Dose	gabapentin 1200 mg: Participants will receive a single oral dose of gabapentin 1200 mg and a placebo that looks like oxycodone HCl

Secondary

Bipolar VAS for "Drug Liking": Area Under the Effect Curve From Time 0 to the Last Available Data (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"

Modified completer population

Posted

Mean

Standard Error

units on a scale * hour

Up to 48 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, and 48 hours)

ID	Title	Description
OG000	Placebo Single Dose	Participants will receive a single oral dose of a placebo that looks like gabapentin and a placebo that looks like oxycodone HCl
OG001	Oxycodone HCl 20 mg Single Dose	Participants will receive a single oral dose of oxycodone HCl 20 mg and a placebo that looks like gabapentin
OG002	Gabapentin 600 mg Single Dose	Participants will receive a single oral dose of gabapentin 600 mg and a placebo that looks like oxycodone HCl

Secondary

Bipolar VAS for "Drug Liking": Area Under the Effect Curve to 1 Hour (AUEC1)

Area under the effect-time profile from time 0 to 1 hour post-dose 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"

Modified completer population

Posted

Mean

Standard Error

units on a scale * hour

Up to 1 hour post-dose (Assessments were made at the following timepoints after each treatment for this outcome measure: 0, 0.25, 0.5, and 1 hour)

ID	Title	Description
OG000	Placebo	Participants received a single oral dose of a placebo that looks like gabapentin and a placebo that looks like oxycodone HCl
OG001	Oxycodone HCl 20 mg Single Dose	Participants received a single oral dose of oxycodone HCl 20 mg and a placebo that looks like gabapentin
OG002	Gabapentin 600 mg Single Dose	Participants received a single oral dose of gabapentin 600 mg and a placebo that looks like oxycodone HCl

Secondary

Bipolar VAS for "Drug Liking": Area Under the Effect Curve to 2 Hours (AUEC2)

Area under the effect-time profile from time 0 to 2 hours post-dose 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"

Modified completer population

Posted

Mean

Standard Error

units on a scale * hour

Up to 2 hours after treatments (Assessments were made at the following timepoints after each treatment for this outcome measure: 0, 0.25, 0.5, 1, 1.5, and 2 hours)

ID	Title	Description
OG000	Placebo	Participants received a single oral dose of a placebo that looks like gabapentin and a placebo that looks like oxycodone HCl
OG001	Oxycodone HCl 20 mg Single Dose	Participants received a single oral dose of oxycodone HCl 20 mg and a placebo that looks like gabapentin
OG002	Gabapentin 600 mg Single Dose	Participants received a single oral dose of gabapentin 600 mg and a placebo that looks like oxycodone HCl

Secondary

Bipolar VAS for "Drug Liking": Area Under the Effect Curve to 3 Hours (AUEC3)

Area under the effect-time profile from time 0 to 3 hours post-dose 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"

Modified completer population

Posted

Mean

Standard Error

units on a scale * hour

up to 3 hours after treatments (Assessments were made at the following timepoints after each treatment for this outcome measure: 0, 0.25, 0.5, 1, 1.5, 2, 2.5, and 3 hours)

ID	Title	Description
OG000	Placebo	Participants received a single oral dose of a placebo that looks like gabapentin and a placebo that looks like oxycodone HCl
OG001	Oxycodone HCl 20 mg Single Dose	Participants received a single oral dose of oxycodone HCl 20 mg and a placebo that looks like gabapentin
OG002	Gabapentin 600 mg Single Dose	Participants received a single oral dose of gabapentin 600 mg and a placebo that looks like oxycodone HCl

Secondary

Bipolar VAS for "Drug Liking": Area Under the Effect Curve to 4 Hours (AUEC4)

Area under the effect-time profile from time 0 to 4 hours post-dose 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"

Modified completer population

Posted

Mean

Standard Error

units on a scale * hour

Up to 4 hours after treatments (Assessments were made 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, and 4 hours)

ID	Title	Description
OG000	Placebo	Participants received a single oral dose of a placebo that looks like gabapentin and a placebo that looks like oxycodone HCl
OG001	Oxycodone HCl 20 mg Single Dose	Participants received a single oral dose of oxycodone HCl 20 mg and a placebo that looks like gabapentin
OG002	Gabapentin 600 mg Single Dose	Participants received a single oral dose of gabapentin 600 mg and a placebo that looks like oxycodone HCl

Secondary

Bipolar VAS for "Drug Liking": Area Under the Effect Curve to 8 Hours (AUEC8)

Area under the effect-time profile from time 0 to 8 hours post-dose 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"

Modified completer population

Posted

Mean

Standard Error

units on a scale * hour

Up to 8 hours after treatments (Assessments were made 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, and 8 hours)

ID	Title	Description
OG000	Placebo	Participants received a single oral dose of a placebo that looks like gabapentin and a placebo that looks like oxycodone HCl
OG001	Oxycodone HCl 20 mg Single Dose	Participants received a single oral dose of oxycodone HCl 20 mg and a placebo that looks like gabapentin
OG002	Gabapentin 600 mg Single Dose	Participants received a single oral dose of gabapentin 600 mg and a placebo that looks like oxycodone HCl

Secondary

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"

Modified completer population

Posted

Mean

Standard Error

Score on a 100 mm scale

up to 48 hours after treatments

ID	Title	Description
OG000	Placebo Single Dose	Participants will receive a single oral dose of a placebo that looks like gabapentin and a placebo that looks like oxycodone HCl
OG001	Oxycodone HCl 20 mg Single Dose	Participants will receive a single oral dose of oxycodone HCl 20 mg and a placebo that looks like gabapentin
OG002	Gabapentin 600 mg Single Dose	Participants will receive a single oral dose of gabapentin 600 mg and a placebo that looks like oxycodone HCl
OG003	Gabapentin 1200 mg Single Dose	Participants will receive a single oral dose of gabapentin 1200 mg and a placebo that looks like oxycodone HCl

Secondary

Unipolar VAS for "High": Time to Maximum Effect (TEmax)

Time after dosing when the maximum effect for "High" VAS is reached

Modified completer population

Posted

Median

Full Range

hours

up to 48 hours after treatments

ID	Title	Description
OG000	Placebo Single Dose	placebo: Participants will receive a single oral dose of a placebo that looks like gabapentin and a placebo that looks like oxycodone HCl
OG001	Oxycodone HCl 20 mg Single Dose	oxycodone HCl 20 mg: Participants will receive a single oral dose of oxycodone HCl 20 mg and a placebo that looks like gabapentin
OG002	Gabapentin 600 mg Single Dose	gabapentin 600 mg: Participants will receive a single oral dose of gabapentin 600 mg and a placebo that looks like oxycodone HCl
OG003	Gabapentin 1200 mg Single Dose	gabapentin 1200 mg: Participants will receive a single oral dose of gabapentin 1200 mg and a placebo that looks like oxycodone HCl

Secondary

Area Under the Effect Curve for "High" VAS (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"

Modified completer population

Posted

Mean

Standard Error

units on a scale * hour

Up to 48 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, and 48 hours)

ID	Title	Description
OG000	Placebo Single Dose	Participants will receive a single oral dose of a placebo that looks like gabapentin and a placebo that looks like oxycodone HCl
OG001	Oxycodone HCl 20 mg Single Dose	Participants will receive a single oral dose of oxycodone HCl 20 mg and a placebo that looks like gabapentin
OG002	Gabapentin 600 mg Single Dose	Participants will receive a single oral dose of gabapentin 600 mg and a placebo that looks like oxycodone HCl
OG003

Secondary

Bipolar VAS for "Take Drug Again"

100 mm visual analog scale at 24, 36, and 48 hours post-dose for the question "I would take this drug again" where 0 = "definitely not", 50 = "neutral", and 100 = "definitely so". The data from the 24, 36, and 48 hours postdose measurements were combined into a single overall model-adjusted value for 24 to 48 hours post-treatment timeframe by estimation from a mixed model with treatment, period, treatment sequence, time, and treatment*time as fixed effects, subject nested within sequence as a random effect. The compound symmetric covariance matrix was employed. Data from all time points were included

Modified completer population

Posted

Least Squares Mean

Standard Error

Score on a 100 mm scale

Up to 48 hours after treatments (Assessments were made at the following timepoints after each treatment for this outcome measure: 24, 36, and 48 hours)

ID	Title	Description
OG000	Placebo Single Dose	placebo: Participants will receive a single oral dose of a placebo that looks like gabapentin and a placebo that looks like oxycodone HCl
OG001	Oxycodone HCl 20 mg Single Dose	oxycodone HCl 20 mg: Participants will receive a single oral dose of oxycodone HCl 20 mg and a placebo that looks like gabapentin
OG002	Gabapentin 600 mg Single Dose

Secondary

Bipolar VAS for "Overall Drug Liking"

100 mm visual analog scale at 24, 36, and 48 hours post-dose for the question "Overall, my liking for this drug is" where 0 = "definitely not", 50 = "neutral", and 100 = "definitely so". The data from the 24, 36, and 48 hours postdose measurements were combined into a single overall model-adjusted value for 24 to 48 hours post-treatment timeframe by estimation from a mixed model with treatment, period, treatment sequence, time, and treatment*time as fixed effects, subject nested within sequence as a random effect. The compound symmetric covariance matrix was employed. Data from all time points were included

Modified completer population

Posted

Least Squares Mean

Standard Error

Score on a 100 mm scale

Up to 48 hours after treatments (Assessments were made at the following timepoints after each treatment for this outcome measure: 24, 36, and 48 hours)

ID	Title	Description
OG000	Placebo Single Dose	Participants will receive a single oral dose of a placebo that looks like gabapentin and a placebo that looks like oxycodone HCl
OG001	Oxycodone HCl 20 mg Single Dose	Participants will receive a single oral dose of oxycodone HCl 20 mg and a placebo that looks like gabapentin
OG002	Gabapentin 600 mg Single Dose

Secondary

Unipolar VAS for "Good Drug Effect"

100 mm visual analog scale for the question "At this moment, I can feel good drug effects" where 0 = "not at all" and 100 = "extremely"

Modified completer population

Posted

Least Squares Mean

Standard Error

Score on a 100 mm scale

up to 48 hours after treatments

ID	Title	Description
OG000	Placebo	Participants received a single oral dose of a placebo that looks like gabapentin and a placebo that looks like oxycodone HCl
OG001	Oxycodone HCl 20 mg Single Dose	Participants received a single oral dose of oxycodone HCl 20 mg and a placebo that looks like gabapentin
OG002	Gabapentin 600 mg Single Dose	Participants received a single oral dose of gabapentin 600 mg and a placebo that looks like oxycodone HCl
OG003	Gabapentin 1200 mg Single Dose	Participants received a single oral dose of gabapentin 1200 mg and a placebo that looks like oxycodone HCl

Secondary

Unipolar VAS for "Bad Drug Effect"

100 mm visual analog scale for the question "At this moment, I can feel bad drug effects" where 0 = "not at all" and 100 = "extremely"

Modified completer population

Posted

Least Squares Mean

Standard Error

Score on a 100 mm scale

up to 48 hours after treatments

ID	Title	Description
OG000	Placebo	Participants received a single oral dose of a placebo that looks like gabapentin and a placebo that looks like oxycodone HCl
OG001	Oxycodone HCl 20 mg Single Dose	Participants received a single oral dose of oxycodone HCl 20 mg and a placebo that looks like gabapentin
OG002	Gabapentin 600 mg Single Dose	Participants received a single oral dose of gabapentin 600 mg and a placebo that looks like oxycodone HCl
OG003	Gabapentin 1200 mg Single Dose	Participants received a single oral dose of gabapentin 1200 mg and a placebo that looks like oxycodone HCl

Secondary

Unipolar VAS for "Any Drug Effect"

100 mm visual analog scale for the question "At this moment, I can feel any drug effects" where 0 = "not at all" and 100 = "extremely"

Modified completer population

Posted

Least Squares Mean

Standard Error

Score on a 100 mm scale

up to 48 hours after treatments

ID	Title	Description
OG000	Placebo	Participants received a single oral dose of a placebo that looks like gabapentin and a placebo that looks like oxycodone HCl
OG001	Oxycodone HCl 20 mg Single Dose	Participants received a single oral dose of oxycodone HCl 20 mg and a placebo that looks like gabapentin
OG002	Gabapentin 600 mg Single Dose	Participants received a single oral dose of gabapentin 600 mg and a placebo that looks like oxycodone HCl
OG003	Gabapentin 1200 mg Single Dose	Participants received a single oral dose of gabapentin 1200 mg and a placebo that looks like oxycodone HCl

Secondary

Cmax of Gabapentin

Maximum plasma concentration of gabapentin

Pharmacokinetic population: all enrolled participants who received study medication and have pharmacokinetic data for the parameters of interest.

Posted

Mean

Standard Deviation

micrograms/milliliter

Up to 48 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, and 48 hours)

ID	Title	Description
OG000	Gabapentin 600 mg Single Dose	Participants received a single oral dose of gabapentin 600 mg and a placebo that looks like oxycodone HCl
OG001	Gabapentin 1200 mg Single Dose	Participants received a single oral dose of gabapentin 1200 mg and a placebo that looks like oxycodone HCl
OG002	Gabapentin 600 mg and Oxycodone HCl 20 mg	Participants received a single oral dose of gabapentin 600 mg and oxycodone HCl 20 mg
OG003	Gabapentin 1200 mg and Oxycodone HCl 20 mg

Secondary

Tmax of Gabapentin

Time when the maximum concentration of gabapentin is reached

Pharmacokinetic population: all enrolled participants who received study medication and have pharmacokinetic data for the parameters of interest

Posted

Median

Full Range

Hours

ID	Title	Description
OG000	Gabapentin 600 mg Single Dose	Participants received a single oral dose of gabapentin 600 mg and a placebo that looks like oxycodone HCl
OG001	Gabapentin 1200 mg Single Dose	Participants received a single oral dose of gabapentin 1200 mg and a placebo that looks like oxycodone HCl
OG002	Gabapentin 600 mg and Oxycodone HCl 20 mg	Participants received a single oral dose of gabapentin 600 mg and oxycodone HCl 20 mg
OG003	Gabapentin 1200 mg and Oxycodone HCl 20 mg

Secondary

AUCinf of Gabapentin

Area under the plasma concentration/time curve from time 0 extrapolated to infinity time of gabapentin

Pharmacokinetic population: all enrolled participants who received study medication and have pharmacokinetic data for the parameters of interest

Posted

Mean

Standard Deviation

micrograms*hour/milliliter

ID	Title	Description
OG000	Gabapentin 600 mg Single Dose	Participants received a single oral dose of gabapentin 600 mg and a placebo that looks like oxycodone HCl
OG001	Gabapentin 1200 mg Single Dose	Participants received a single oral dose of gabapentin 1200 mg and a placebo that looks like oxycodone HCl
OG002	Gabapentin 600 mg and Oxycodone HCl 20 mg	Participants received a single oral dose of gabapentin 600 mg and oxycodone HCl 20 mg
OG003	Gabapentin 1200 mg and Oxycodone HCl 20 mg

Secondary

AUClast of Gabapentin

Area under the plasma concentration/time profile from time 0 to the time of the last quantifiable concentration of gabapentin

Pharmacokinetic population: all enrolled participants who received study medication and have pharmacokinetic data for the parameters of interes

Posted

Mean

Standard Deviation

micrograms*hour/milliliter

Up to 48 hours after treatment (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, and 48 hours)

ID	Title	Description
OG000	Gabapentin 600 mg Single Dose	Participants received a single oral dose of gabapentin 600 mg and a placebo that looks like oxycodone HCl
OG001	Gabapentin 1200 mg Single Dose	Participants received a single oral dose of gabapentin 1200 mg and a placebo that looks like oxycodone HCl
OG002	Gabapentin 600 mg and Oxycodone HCl 20 mg	Participants received a single oral dose of gabapentin 600 mg and oxycodone HCl 20 mg
OG003	Gabapentin 1200 mg and Oxycodone HCl 20 mg

Secondary

Half-life (t½) of Gabapentin

Half-life (t½) of gabapentin

Pharmacokinetic population: all enrolled participants who received study medication and have pharmacokinetic data for the parameters of interest

Posted

Mean

Standard Deviation

Hours

ID	Title	Description
OG000	Gabapentin 600 mg Single Dose	Participants received a single oral dose of gabapentin 600 mg and a placebo that looks like oxycodone HCl
OG001	Gabapentin 1200 mg Single Dose	Participants received a single oral dose of gabapentin 1200 mg and a placebo that looks like oxycodone HCl
OG002	Gabapentin 600 mg and Oxycodone HCl 20 mg	Participants received a single oral dose of gabapentin 600 mg and oxycodone HCl 20 mg
OG003	Gabapentin 1200 mg and Oxycodone HCl 20 mg

Secondary

Cmax of Oxycodone

Maximum plasma concentration of Oxycodone

Pharmacokinetic population: all enrolled participants who received study medication and have pharmacokinetic data for the parameters of interest

Posted

Mean

Standard Deviation

nanograms/milliliter

ID	Title	Description
OG000	Oxycodone HCl 20 mg Single Dose	Participants received a single oral dose of oxycodone HCl 20 mg and a placebo that looks like gabapentin
OG001	Gabapentin 600 mg and Oxycodone HCl 20 mg	Participants received a single oral dose of gabapentin 600 mg and oxycodone HCl 20 mg
OG002	Gabapentin 1200 mg and Oxycodone HCl 20 mg	Participants received a single oral dose of gabapentin 1200 mg and oxycodone HCl 20 mg

Units	Counts

Secondary

Tmax of Oxycodone

Time when the maximum concentration of Oxycodone is reached

Pharmacokinetic population: all enrolled participants who received study medication and have pharmacokinetic data for the parameters of interest

Posted

Median

Full Range

hours

ID	Title	Description
OG000	Oxycodone HCl 20 mg Single Dose	Participants received a single oral dose of oxycodone HCl 20 mg and a placebo that looks like gabapentin
OG001	Gabapentin 600 mg and Oxycodone HCl 20 mg	Participants received a single oral dose of gabapentin 600 mg and oxycodone HCl 20 mg
OG002	Gabapentin 1200 mg and Oxycodone HCl 20 mg	Participants received a single oral dose of gabapentin 1200 mg and oxycodone HCl 20 mg

Units	Counts

Secondary

AUCinf of Oxycodone

Area under the plasma concentration/time curve from time 0 extrapolated to infinity time of Oxycodone

Pharmacokinetic population: all enrolled participants who received study medication and have pharmacokinetic data for the parameters of interest

Posted

Mean

Standard Deviation

nanograms*hour/milliliter

ID	Title	Description
OG000	Oxycodone HCl 20 mg Single Dose	Participants received a single oral dose of oxycodone HCl 20 mg and a placebo that looks like gabapentin
OG001	Gabapentin 600 mg and Oxycodone HCl 20 mg	Participants received a single oral dose of gabapentin 600 mg and oxycodone HCl 20 mg
OG002	Gabapentin 1200 mg and Oxycodone HCl 20 mg	Participants received a single oral dose of gabapentin 1200 mg and oxycodone HCl 20 mg

Secondary

AUClast of Oxycodone

Area under the plasma concentration/time profile from time 0 to the time of the last quantifiable concentration of Oxycodone

Pharmacokinetic population: all enrolled participants who received study medication and have pharmacokinetic data for the parameters of interest

Posted

Mean

Standard Deviation

nanograms*hour/milliliter

ID	Title	Description
OG000	Oxycodone HCl 20 mg Single Dose	Participants received a single oral dose of oxycodone HCl 20 mg and a placebo that looks like gabapentin
OG001	Gabapentin 600 mg and Oxycodone HCl 20 mg	Participants received a single oral dose of gabapentin 600 mg and oxycodone HCl 20 mg
OG002	Gabapentin 1200 mg and Oxycodone HCl 20 mg	Participants received a single oral dose of gabapentin 1200 mg and oxycodone HCl 20 mg

Secondary

Half-life (t½) of Oxycodone

Pharmacokinetic population: all enrolled participants who received study medication and have pharmacokinetic data for the parameters of interest

Posted

Median

Full Range

hours

ID	Title	Description
OG000	Oxycodone HCl 20 mg Single Dose	Participants received a single oral dose of oxycodone HCl 20 mg and a placebo that looks like gabapentin
OG001	Gabapentin 600 mg and Oxycodone HCl 20 mg	Participants received a single oral dose of gabapentin 600 mg and oxycodone HCl 20 mg
OG002	Gabapentin 1200 mg and Oxycodone HCl 20 mg	Participants received a single oral dose of gabapentin 1200 mg and oxycodone HCl 20 mg

Units	Counts

ID	Title	Description	Deaths (At Risk)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	Participants received a single oral dose of a placebo that looks like gabapentin and a placebo that looks like oxycodone HCl	53	53	0	53
EG001	Oxycodone HCl 20 mg Single Dose	Participants received a single oral dose of oxycodone HCl 20 mg and a placebo that looks like gabapentin	52	52	4	52
EG002	Gabapentin 600 mg Single Dose	Participants received a single oral dose of gabapentin 600 mg and a placebo that looks like oxycodone HCl	51	51	0	51
EG003	Gabapentin 1200 mg Single Dose	Participants received a single oral dose of gabapentin 1200 mg and a placebo that looks like oxycodone HCl	52	52	2	52
EG004	Gabapentin 600 mg and Oxycodone HCl 20 mg	Participants received a single oral dose of gabapentin 600 mg and oxycodone HCl 20 mg	52	52	4	52
EG005	Gabapentin 1200 mg and Oxycodone HCl 20 mg	Participants received a single oral dose of gabapentin 1200 mg and oxycodone HCl 20 mg	52	52	2	52

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Nausea	Gastrointestinal disorders	MedDRA (24.1)	Non-systematic Assessment	EG0000 events0 affected53 at risk EG0014 events4 affected52 at risk EG0020 events0 affected51 at risk EG0030 events0 affected52 at risk EG0044 events4 affected52 at risk EG0052 events2 affected52 at risk
Vomiting	Gastrointestinal disorders	MedDRA (24.1)	Non-systematic Assessment	EG0000 events0 affected53 at risk EG0010 events0 affected52 at risk EG0020 events0 affected51 at risk EG003
Muscle strain	Injury, poisoning and procedural complications	MedDRA (24.1)	Non-systematic Assessment	EG0000 events0 affected53 at risk EG0010 events0 affected52 at risk EG0020 events0 affected51 at risk EG003

ID	Term
D000588	Amines
D009930	Organic Chemicals
D005680	gamma-Aminobutyric Acid
D000613	Aminobutyrates
D002087	Butyrates
D000144	Acids, Acyclic
D002264	Carboxylic Acids
D003509	Cyclohexanecarboxylic Acids
D000146	Acids, Carbocyclic
D003510	Cyclohexanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D000596	Amino Acids
D000602	Amino Acids, Peptides, and Proteins
D003061	Codeine
D009022	Morphine Derivatives
D009019	Morphinans
D053610	Opiate Alkaloids
D000470	Alkaloids
D006571	Heterocyclic Compounds
D006572	Heterocyclic Compounds, Bridged-Ring
D006576	Heterocyclic Compounds, 4 or More Rings
D000072471	Heterocyclic Compounds, Fused-Ring
D010616	Phenanthrenes
D011084	Polycyclic Aromatic Hydrocarbons
D011083	Polycyclic Compounds