Adults 18 to 55, any sex, with Abuse Potential. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Bipolar Visual Analog Scale (VAS) for "Drug Liking" Maximum Effect (Emax).Primary· up to 48 hours after treatments
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"
Group
Value
95% CI
Placebo
54.89
± 2.116
Oxycodone HCl 20 mg Single Dose
87.40
± 3.156
Gabapentin 600 mg Single Dose
57.89
± 3.142
Gabapentin 1200 mg Single Dose
63.62
± 3.334
Gabapentin 600 mg and Oxycodone HCl 20 mg
88.43
± 3.216
Gabapentin 1200 mg and Oxycodone HCl 20 mg
92.17
± 2.713
Bipolar VAS for "Drug Liking" - Time to Maximum Effect (TEmax)Secondary· up to 48 hours after treatments
Time after dosing when the maximum effect for Drug Liking VAS is reached
Group
Value
95% CI
Placebo Single Dose
0.25
0.2 – 24.0
Oxycodone HCl 20 mg Single Dose
1.00
0.2 – 3.5
Gabapentin 600 mg Single Dose
0.25
0.25 – 2.5
Gabapentin 1200 mg Single Dose
0.28
0.1 – 12.1
Gabapentin 600 mg and Oxycodone HCl 20 mg
1.00
0.2 – 12.0
Gabapentin 1200 mg and Oxycodone HCl 20 mg
1.50
0.2 – 4.0
Bipolar VAS for "Drug Liking": Area Under the Effect Curve From Time 0 to the Last Available Data (AUEClast)Secondary· 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)
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"
Group
Value
95% CI
Placebo Single Dose
2394.21
± 65.274
Oxycodone HCl 20 mg Single Dose
2661.43
± 84.274
Gabapentin 600 mg Single Dose
2422.37
± 85.855
Gabapentin 1200 mg Single Dose
2444.4
± 83.580
Gabapentin 600 mg and Oxycodone HCl 20 mg
2744.86
± 76.342
Gabapentin 1200 mg and Oxycodone HCl 20 mg
2759.57
± 74.589
Bipolar VAS for "Drug Liking": Area Under the Effect Curve to 1 Hour (AUEC1)Secondary· 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)
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"
Group
Value
95% CI
Placebo
50.17
± 0.317
Oxycodone HCl 20 mg Single Dose
58.86
± 1.478
Gabapentin 600 mg Single Dose
51.28
± 1.440
Gabapentin 1200 mg Single Dose
50.61
± 0.568
Gabapentin 600 mg and Oxycodone HCl 20 mg
57.02
± 1.771
Gabapentin 1200 mg and Oxycodone HCl 20 mg
55.76
± 1.390
Bipolar VAS for "Drug Liking": Area Under the Effect Curve to 2 Hours (AUEC2)Secondary· 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)
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"
Group
Value
95% CI
Placebo
102.62
± 1.791
Oxycodone HCl 20 mg Single Dose
140.44
± 4.434
Gabapentin 600 mg Single Dose
105.20
± 4.017
Gabapentin 1200 mg Single Dose
107.19
± 2.449
Gabapentin 600 mg and Oxycodone HCl 20 mg
138.72
± 4.340
Gabapentin 1200 mg and Oxycodone HCl 20 mg
133.84
± 4.010
Bipolar VAS for "Drug Liking": Area Under the Effect Curve to 3 Hours (AUEC3)Secondary· 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)
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"
Group
Value
95% CI
Placebo
155.48
± 3.651
Oxycodone HCl 20 mg Single Dose
219.31
± 7.614
Gabapentin 600 mg Single Dose
161.07
± 6.535
Gabapentin 1200 mg Single Dose
164.03
± 4.819
Gabapentin 600 mg and Oxycodone HCl 20 mg
223.22
± 7.326
Gabapentin 1200 mg and Oxycodone HCl 20 mg
214.99
± 6.567
Bipolar VAS for "Drug Liking": Area Under the Effect Curve to 4 Hours (AUEC4)Secondary· 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)
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"
Group
Value
95% CI
Placebo
208.32
± 5.171
Oxycodone HCl 20 mg Single Dose
294.28
± 10.329
Gabapentin 600 mg Single Dose
214.53
± 8.878
Gabapentin 1200 mg Single Dose
220.08
± 6.896
Gabapentin 600 mg and Oxycodone HCl 20 mg
305.08
± 10.423
Gabapentin 1200 mg and Oxycodone HCl 20 mg
293.99
± 8.810
Bipolar VAS for "Drug Liking": Area Under the Effect Curve to 8 Hours (AUEC8)Secondary· 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)
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"
Group
Value
95% CI
Placebo
411.58
± 12.224
Oxycodone HCl 20 mg Single Dose
551.53
± 19.517
Gabapentin 600 mg Single Dose
421.12
± 17.144
Gabapentin 1200 mg Single Dose
438.30
± 13.862
Gabapentin 600 mg and Oxycodone HCl 20 mg
599.96
± 22.312
Gabapentin 1200 mg and Oxycodone HCl 20 mg
574.98
± 18.952
Unipolar VAS for "High" - Maximum Effect (Emax)Secondary· up to 48 hours after treatments
Maximum effect on the 100 mm visual analog scale for the question "I am feeling high" where 0 = "not at all" and 100 = "extremely"
Group
Value
95% CI
Placebo Single Dose
13.45
± 4.854
Oxycodone HCl 20 mg Single Dose
77.36
± 5.8160
Gabapentin 600 mg Single Dose
28.61
± 6.551
Gabapentin 1200 mg Single Dose
25.21
± 6.412
Gabapentin 600 mg and Oxycodone HCl 20 mg
81.86
± 5.620
Gabapentin 1200 mg and Oxycodone HCl 20 mg
88.74
± 4.210
Unipolar VAS for "High": Time to Maximum Effect (TEmax)Secondary· up to 48 hours after treatments
Time after dosing when the maximum effect for "High" VAS is reached
Group
Value
95% CI
Placebo Single Dose
0.25
0.2 – 8.0
Oxycodone HCl 20 mg Single Dose
1.00
0.3 – 4.0
Gabapentin 600 mg Single Dose
0.26
0.2 – 8.0
Gabapentin 1200 mg Single Dose
0.27
0.1 – 144.9
Gabapentin 600 mg and Oxycodone HCl 20 mg
1.00
0.2 – 48.1
Gabapentin 1200 mg and Oxycodone HCl 20 mg
1.50
0.2 – 4.1
Area Under the Effect Curve for "High" VAS (AUEClast)Secondary· 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)
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"
Group
Value
95% CI
Placebo Single Dose
33.45
± 14.904
Oxycodone HCl 20 mg Single Dose
321.75
± 46.346
Gabapentin 600 mg Single Dose
86.41
± 31.541
Gabapentin 1200 mg Single Dose
123.74
± 50.060
Gabapentin 600 mg and Oxycodone HCl 20 mg
512.08
± 66.299
Gabapentin 1200 mg and Oxycodone HCl 20 mg
425.01
± 52.651
Bipolar VAS for "Take Drug Again"Secondary· 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)
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
Group
Value
95% CI
Placebo Single Dose
53.43
± 2.928
Oxycodone HCl 20 mg Single Dose
72.16
± 2.918
Gabapentin 600 mg Single Dose
55.19
± 2.942
Gabapentin 1200 mg Single Dose
58.05
± 2.935
Gabapentin 600 mg and Oxycodone HCl 20 mg
79.16
± 2.940
Gabapentin 1200 mg and Oxycodone HCl 20 mg
77.85
± 2.910
Adverse events — posted to ClinicalTrials.gov
Time frame: During the entire Treatment Phase of the study, which encompassed the time interval from admission of the subject to their first Treatment Period until 28 days after study drug dosing in their last (6th) Treatment Period, including the washout in between Treatment Periods. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed all 6 treatment periods, and it lasted up to approximately 13 weeks..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This will be a randomized, double-blind, double-dummy, placebo- and active-controlled, 6 treatment, 6-period crossover single-dose, Williams square design study in healthy male and/or female adult, non-drug-dependent recreational opioid users.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Viatris Specialty LLC
Last refreshed: 14 August 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05319756.