NCT03286218

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Recreational Drug Use
• Prescription Drug Abuse (Not Dependent)

Interventions

Type	Name	Description
DRUG	Lasmiditan	Administered orally
DRUG	Alprazolam	Administered orally
DRUG	Placebo	Administered orally

Timeline

• Start date: 2017-09-15
• Primary completion: 2017-11-20
• Completion: 2017-11-20
• First posted: 2017-09-18
• Last updated: 2020-01-10
• Results posted: 2020-01-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study