CompletedPhase 1

A Study of the Abuse Potential of Lasmiditan in Participants Who Are Recreational Drug Users

United States96 participantsStarted 2017-09-15

Plain-language summary

The purpose of this study is to assess the abuse potential of study drug lasmiditan. Lasmiditan will be compared to a marketed benzodiazepine, alprazolam (positive control), as well as to placebo (dummy substance that looks like lasmiditan or alprazolam without any active drug) to determine the potential for drug abuse. The dosages will be in tablet form and will be taken orally (by mouth). This study will last about 55 days, including screening. Screening will occur within 28 days prior to qualification phase.

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: * Are overtly healthy males or females, as determined by medical history and physical examination. * Have a body mass index (BMI) of 18 to 32 kilograms per meter squared (kg/m²) inclusive, at the time of screening. * Must be recreational drug user and agree not to consume any recreational drugs during the study. Exclusion Criteria: * Have known allergies to lasmiditan, alprazolam, related compounds, or any components of the formulation, or a history of significant atopy. * Are currently seeking or participating in treatment for addiction or substance-related disorders, or have recovered from substance abuse disorder. * Are currently taking excluded prescription or over-the-counter (OTC) medications. * Have a history of significant sleep disorder, including sleep apnea or narcolepsy. * Have a history of orthostatic hypotension, vertigo, syncope, or presyncope. * Have a history of brain injury, including a history of concussions.

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

Pharmacodynamics (PD): Maximal Effect Score (Emax) of Bipolar Drug Liking Visual Analog Scale (VAS) Scores

Timeframe: Each Phase: 24 Hours

Trial details

NCT IDNCT03286218

SponsorEli Lilly and Company

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-11-20

Results submitted2019-11-08

View on ClinicalTrials.gov More Recreational Drug Use trials