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



Status:Completed
Conditions:Psychiatric
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - 55
Updated:12/15/2017
Start Date:September 15, 2017
End Date:November 20, 2017

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A Randomized, Subject- and Investigator-Blind, Placebo and Active-Controlled Study to Assess the Abuse Potential of Lasmiditan

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.


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, syncopy, or presyncopy.

- Have a history of brain injury, including a history of concussions.
We found this trial at
1
site
Overland Park, Kansas 23112
Principal Investigator: Debra Kelsh, MD
Phone: 913-696-1601
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from
Overland Park, KS
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