A Randomized, Double Blind, Active and Placebo Controlled, 5 Way Crossover Study to Determine the Abuse Potential of Orally Administered Gabapentin Enacarbil Immediate Release Capsules in Healthy, Nondependent Recreational Drug Users With Sedative Experience
Overview
- Phase
- Phase 4
- Intervention
- Gabapentin Enacarbil Immediate Release (GE-IR) 700 mg
- Conditions
- Abuse Potential
- Sponsor
- Arbor Pharmaceuticals, Inc.
- Enrollment
- 86
- Locations
- 1
- Primary Endpoint
- Drug Liking "at This Moment" Visual Analog Scale (VAS)
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
The purpose of this study is to assess the abuse potential of gabapentin enacarbil in healthy adult, non-dependent, recreational drug users.
Detailed Description
The primary purpose of this study is to evaluate the abuse potential of gabapentin enacarbil immediate-release (GE-IR), the active moiety in Horizant in comparison to placebo and an active control with known abuse potential (i.e., alprazolam). This study will be a randomized, double-blind, active- and placebo-controlled, 5-way crossover study to determine the abuse potential of gabapentin enacarbil immediate release (GE-IR) relative to alprazolam (active control) and placebo, in nondependent, recreational drug users with sedative drug use experience. This study will consist of 3 phases: screening, qualification, and treatment.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Provision of signed and dated informed consent form (ICF),
- •Stated willingness to comply with all study procedures and availability for the duration of the study,
- •Male or female, between 18 and 55 years of age, inclusive,
- •Current nondependent, recreational drug user who has used sedative drugs for recreational (nontherapeutic) purposes (i.e., for psychoactive effects) at least 10 times in the subject's lifetime and at least once in the 12 weeks before screening,
- •Body mass index (BMI) within 18.0 kg/m\^2 to 36.0 kg/m\^2, inclusive,
- •If female, meets 1 of the following criteria:
- •If of childbearing potential agrees to use 1 of the accepted contraceptive regimens from at least 30 days prior to the first study drug administration, during the study, and for at least 30 days after the last dose of the study drug. An acceptable method of contraception includes 1 of the following:
- •Abstinence from heterosexual intercourse,
- •Hormonal contraceptives (birth control pills, injectable/implantable/insertable hormonal birth control products, transdermal patch),
- •Intrauterine device (IUD; with or without hormones), Or
Exclusion Criteria
- •History of significant hepatic, renal, cardiovascular, pulmonary, hematologic, neurological, psychiatric, gastrointestinal, endocrine, immunologic, ophthalmologic, or dermatologic disease of any etiology (including infections),
- •Presence or history of significant gastrointestinal, liver or kidney disease, or surgery that may affect drug bioavailability with the exception that cholecystectomy is permitted at the discretion of an investigator,
- •Presence of any significant respiratory illness or presence or history of chronic respiratory disease (e.g., upper respiratory illness, sleep apnea, emphysema, asthma) at screening (subjects with acute respiratory illness may be rescheduled upon resolution at the discretion of an investigator),
- •Personal or family history (first degree relatives) of allergy, hypersensitivity, or drug rash with eosinophilia and systemic symptoms (DRESS) syndrome to gabapentin enacarbil, gabapentin or any drug product including anti-convulsants (e.g., alprazolam, carbamazepine) or related drugs (e.g., other benzodiazepines) or known excipients of any of the drug products in this study (e.g., lactose),
- •History of sensitivity to or poor tolerance of gabapentin enacarbil, gabapentin, pregabalin, or alprazolam,
- •Female who is lactating at screening,
- •Female who is pregnant according to the pregnancy test at screening or prior to the first study drug administration or planning to become pregnant within 30 days following the last study drug administration,
- •History of substance or alcohol dependence (excluding nicotine and caffeine) within the past 2 years, as defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV), and/or subject has been in a drug or alcohol rehabilitation program within the last 2 years,
- •Subjects with positive urine drug screen (UDS) results at screening and admission will be assessed for inclusion at the discretion of an Investigator. If tetrahydrocannabinol (THC) is positive at admission to the Qualification phase and Treatment phase, as applicable, a cannabis intoxication evaluation will be done by an investigator and subjects may be permitted to continue in the study, rescheduled, or discontinued at the discretion of an investigator. Other positive test results should be reviewed to determine if the subject may be rescheduled, in the opinion of the investigator,
- •Is a heavy smoker (\>20 cigarettes per day or nicotine-equivalent) and/or is unable to abstain from smoking or unable to abstain from the use of prohibited nicotine-containing products for at least 1 hour before and 6 hours after study drug administration (including e-cigarettes, pipes, cigars, chewing tobacco, nicotine topical patches, nicotine gum, or nicotine lozenges),
Arms & Interventions
GE-IR 700 mg
* Single oral dose * Drug: GE-IR 700 mg capsule
Intervention: Gabapentin Enacarbil Immediate Release (GE-IR) 700 mg
Placebo
- Single oral dose
Intervention: Placebo
Alprazolam 2 mg
* Single oral dose * Drug: Alprazolam 2 mg capsule
Intervention: Alprazolam 2 mg
GE-IR 200 mg
* Single oral dose * Drug: GE-IR 200 mg capsule
Intervention: Gabapentin Enacarbil Immediate Release (GE-IR) 200 mg
GE-IR 450 mg
* Single oral dose * Drug: GE-IR 450 mg capsule
Intervention: Gabapentin Enacarbil Immediate Release (GE-IR) 450 mg
Outcomes
Primary Outcomes
Drug Liking "at This Moment" Visual Analog Scale (VAS)
Time Frame: approximately 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, and 24 hours postdose in the treatment phase and per period of the treatment phase
Mean difference in Drug Liking Emax over 24 hours for Drug Liking ("At this moment, my liking for this drug is"), assessed on a bipolar (0 to 100 points; 0: Strong disliking, 50: Neither like nor dislike, 100: Strong liking) VAS.
Secondary Outcomes
- Take Drug Again VAS(approximately 12 and 24 hours postdose in the treatment phase and per period of the treatment phase)
- Overall Drug Liking VAS(approximately 12 and 24 hours postdose in the treatment phase and per period of the treatment phase)
- High VAS(within 1 hour prior to and approximately 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, and 24 hours postdose in the treatment phase and per period of the treatment phase)