Study Evaluating Abuse Potential of Lyrica® in Healthy Non-Drug Dependent Recreational Opioid Users
Condition: Abuse Potential
Intervention: Pregabalin 300mg; pregabalin 450 mg; Pregabalin 300 mg with oxycodone 20 mg; pregabalin 450 mg with oxycodone 20 mg; oxycodone 20 mg; Placebo
Intervention description: 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; 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
Intervention MeSH terms: Pregabalin; Oxycodone
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: 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.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Lyrica; Pregabalin; Oxycodone; Opioid; Abuse liability

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male and female participants must be 18 to 55 years of age, inclusive, at the time of
             screening. There must be no less than 20% female participants in the Treatment Phase.

          2. Male and female participants who are overtly healthy. Healthy is defined as no
             clinically relevant abnormalities identified by a detailed medical history, full
             physical examination, vital signs, 12-lead ECG, and/or clinical laboratory tests.

          3. 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).

          4. Participants must satisfactorily complete both the Naloxone Challenge and the Drug
             Discrimination.

          5. Participants who are willing and able to comply with all scheduled visits, treatment
             plan, laboratory tests, lifestyle considerations, and other study procedures.

          6. Body mass index (BMI) of 17.5 to 34 kg/m2, inclusive; and a total body weight

             ≥50 kg (110 lb).

          7. Capable of giving signed informed consent, which includes compliance with the
             requirements and restrictions listed in the informed consent document (ICD).

        Exclusion Criteria:

          1. 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-4
             (DSM-4) 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.

          2. 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).

          3. Any condition possibly affecting drug absorption (eg, gastrectomy) excluding
             cholecystectomy within 1 year prior to study.

          4. Abnormal baseline EtCO2 <35mm Hg or >45 mm Hg.

          5. 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).

          6. Participants with active suicidal ideation or suicidal behavior within 5 year 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.

          7. 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.

          8. Patients with: sleep apnea, myasthenia gravis and glaucoma.

          9. 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.

         10. Herbal supplements and herbal medications must be discontinued at least 28 days prior
             to the first dose of study medication.

         11. 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.

         12. Positive urine drug screen (UDS) for substances of abuse at each admission in the
             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 participant is permitted to participate in any
             phase of the study.

         13. Unable to abstain from using THC during the Qualification and Treatment Phase of the
             study.

         14. Has participated in, is currently participating in, or is seeking treatment for
             substance-and/or alcohol-related disorders (excluding nicotine and caffeine).

         15. Has a positive alcohol breathalyzer or urine test at each admission to the study
             center during qualification and treatment phase. Positive results may be repeated
             and/or participants re-scheduled at the Investigator's discretions.

         16. Participants are heavy smokers or users of other types of nicotine products (>20
             cigarettes equivalents per day).

         17. Participants are unable to abstain from smoking for at least 2 hours before and at
             least 8 hours after study drug administration.

         18. 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.

         19. 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.

         20. 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.

         21. Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more
             within 60 days prior to dosing.

         22. History of sensitivity to heparin or heparin-induced thrombocytopenia.

         23. Unwilling or unable to comply with the criteria in the Lifestyle Considerations
             section of this protocol.

         24. History of hypersensitivity to pregabalin or oxycodone or any of the components in the
             formulation of the study products.

         25. 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.