Abuse Potential of HORIZANT With and Without Oxycodone in Healthy, Nondependent Recreational Opio… (NCT06247488) | Clinical Trial Compass
CompletedPhase 4
Abuse Potential of HORIZANT With and Without Oxycodone in Healthy, Nondependent Recreational Opioid Users
United States110 participantsStarted 2022-01-31
Plain-language summary
The purpose of this study is to assess the abuse potential of gabapentin enacarbil immediate release capsules taken alone and in combination with oxycodone in healthy adult, non-dependent, recreational opioid users.
Who can participate
Age range
18 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 opioid user who has used opioid drugs for recreational (nontherapeutic) purposes (i.e., for psychoactive effects) at least 5 times in the subject's lifetime and at least once in the last 12 weeks,
. Body mass index (BMI) within 18.0 kg/m2 to 36.0 kg/m2, 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 treatment administration, during the study, and for at least 30 days after the last dose of the study treatment. An acceptable method of contraception includes 1 of the following:
. If of childbearing potential agrees to use a double barrier method (e.g., condom and spermicide) during the study and for at least 30 days after the last dose of study treatment.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Drug Liking Visual Analog Scale (VAS)
Timeframe: 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
. 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 naloxone, opioids (e.g., oxycodone), or related drugs 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, naloxone, or oxycodone,
. Female who is lactating at screening,
. Female who is pregnant according to the pregnancy test at screening or prior to the first study treatment administration or planning to become pregnant within 30 days following the last study treatment 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 ever been in a drug or alcohol rehabilitation program within the last 2 years,