This is a Phase 4 clinical study in healthy non-drug dependent recreational opioid users to assess the abuse potential of Lyrica when taken alone or in combination with oxycodone.
This is a randomized, double-blind, double-dummy, placebo- and active-controlled, 6-treatment, 6-period crossover, single-dose study in healthy male and/or female adult, non drug-dependent recreational opioid users. The study includes Screening, a Qualification Phase, a Treatment Phase and Follow-up. This study will randomize approximately 60 adult male and female (at least 20% female) participants (10 participants in each sequence) in the Treatment Phase to ensure at least 48 participants complete the Treatment Phase of the study. There will be 8 visits to the clinic in total and a follow-up telephone call at the end of the study. The duration of participation will be approximately 16 weeks and 7 of the visits will involve clinic stays of 4 days/3 nights.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
60
Participant will receive an oral dose of pregabalin 300 mg
Participant will receive an oral dose of pregabalin 450 mg
Participant will receive an oral dose of pregabalin 300 mg and oxycodone 20 mg
Hassman Research Institute
Marlton, New Jersey, 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 ("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"
Time frame: up to 48 hours after treatment
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 48 hours after treatment
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
Time frame: Up to 48 hours after treatment (assessments were made at the following timepoints after each treatment for this outcome measure: 24, 36, and 48 hours)
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Participant will receive an oral dose of pregabalin 450 mg and oxycodone 20 mg
Participant will receive an oral dose of oxycodone 20 mg
Participant will receive an oral dose of placebo
Time frame: Up to 48 hours after treatment (assessments were made at the following timepoints after each treatment for this outcome measure: 24, 36, and 48 hours)
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"
Time frame: up to 48 hours after treatment