Study Evaluating the Abuse Potential of NEURONTIN® in Healthy Non-drug Dependent, Recreational Opioid Users
Condition: Abuse Potential
Intervention: gabapentin 600 mg; gabapentin 1200 mg; gabapentin 600 mg and oxycodone HCl 20 mg; gabapentin 1200 mg and oxycodone HCl 20 mg; oxycodone HCl 20 mg; placebo
Intervention description: Participants will receive a single oral dose of gabapentin 600 mg and a placebo that looks like oxycodone HCl; Participants will receive a single oral dose of gabapentin 1200 mg and a placebo that looks like oxycodone HCl; Participants will receive a single oral dose of gabapentin 600 mg and oxycodone HCl 20 mg; Participants will receive a single oral dose of gabapentin 1200 mg and oxycodone HCl 20 mg; Participants will receive a single oral dose of oxycodone HCl 20 mg and a placebo that looks like gabapentin; Participants will receive a single oral dose of a placebo that looks like gabapentin and a placebo that looks like oxycodone HCl
Intervention MeSH terms: Oxycodone; Gabapentin
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 54.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Neurontin; Oxycodone; Abuse Liability; Gabapentin

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. 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.

          2. 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.

          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 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:

          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 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.

          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 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.

          7. Participants with any history of sleep apnea, myasthenia gravis or glaucoma.

          8. 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.

          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.
             (Refer to Section 6.5 for additional details).

         10. Herbal supplements, herbal medications and hormone replacement therapy 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
             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.

         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 Phases. 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 gabapentin 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.