A Study of the Abuse Liability Potential of Cenobamate in Recreational Drug Users (NCT03509285) | Clinical Trial Compass
CompletedPhase 1
A Study of the Abuse Liability Potential of Cenobamate in Recreational Drug Users
United States, Canada53 participantsStarted 2017-03-08
Plain-language summary
This randomized, single-dose, placebo- and active-controlled, crossover study will evaluate the abuse liability potential of cenobamate in recreational drug users with sedative drug use experience.
In the Qualification phase, subjects will receive a single dose of either alprazolam or placebo in a crossover design, with a wash-out period of at least 24 hours between treatments. Subjects who are clearly able to distinguish the positive control from placebo will be enrolled in the Treatment phase and will be randomized to single oral doses of cenobamate (2 dose levels), alprazolam (2 dose levels), and placebo in a double-blind, double-dummy, 5-way crossover design. Washout-periods between the 5 treatment periods in the Treatment phase will be at least 16 days.
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
. Healthy male or female subjects 18 to 55 years of age, inclusive.
. Body mass index (BMI) within the range of 19.0 to 32.0 kg/m2, inclusive, and a minimum weight of 50.0 kg.
. Current recreational drug users who have used benzodiazepines for recreational (non-therapeutic) purposes (i.e., for psychoactive effects) at least 5 times in the past year and used benzodiazepines at least once in the 12 weeks before Screening.
. Female subjects of childbearing potential with male sexual partners must be using and willing to continue using medically acceptable contraception (as specified in Section 4.5.2) for at least 1 month prior to Screening (at least 3 months for oral and transdermal contraceptives) and for at least 30 days after the last study drug administration.
. Female subjects of non-childbearing potential must meet the criteria specified in Section 4.5.2.
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
Pharmacodynamics using Visual Analogue Scales (VAS)
Timeframe: Measured for 24 hrs in each Treatment Period
. Male subjects with female sexual partners of childbearing potential must be using and willing to continue using medically acceptable contraception (as specified in Section 4.5.2) from Screening and for at least 30 days after the last study drug administration.
. Able to speak, read, and understand English sufficiently to allow completion of all study assessments.
. Must understand and provide written informed consent, prior to the initiation of any protocol-specific procedures.
Exclusion criteria
. Substance or alcohol dependence within the past 2 years, as defined by the Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition - Text Revision (DSM IV-TR), and/or has ever participated or plans to participate in a substance or alcohol rehabilitation program to treat their substance or alcohol dependence (excluding nicotine and caffeine).
. Heavy smoker (\>20 cigarettes per day) and/or is unable to abstain from smoking or unable to abstain from the use of prohibited nicotine-containing products for at least 10 hours during the in-clinic periods (including e-cigarettes, pipes, cigars, chewing tobacco, nicotine-topical patches, nicotine gum, or nicotine lozenges).
. History or presence of clinically significant abnormality as assessed by physical examination, medical history (including cholecystectomy), ECGs, vital signs, or laboratory values, which in the opinion of the investigator would jeopardize the safety of the subject or the validity of the study results.
. History or presence of myasthenia gravis, severe hepatic insufficiency, severe respiratory insufficiency, sleep apnea syndrome, or acute narrow angle glaucoma.
. Positive for hepatitis B, hepatitis C, or human immunodeficiency virus (HIV).
. Evidence of clinically significant hepatic or renal impairment including alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>1.5× the upper limit of normal (ULN), or bilirubin \>1× ULN. Repeat safety laboratory tests are allowed once for Screening, unless the principal investigator and sponsor agree to an additional repeat.
. Donation or loss of more than 500 mL whole blood within 30 days preceding entry into the Treatment Phase.
. Difficulty with venous access or unsuitable or unwilling to undergo catheter insertion.