Status:
COMPLETED
A Study of the Abuse Potential of Lasmiditan in Participants Who Are Recreational Drug Users
Lead Sponsor:
Eli Lilly and Company
Conditions:
Recreational Drug Use
Prescription Drug Abuse (Not Dependent)
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief 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 (du...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 15 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 20 2017
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT03286218
Start Date
September 15 2017
End Date
November 20 2017
Last Update
January 10 2020
Active Locations (1)
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1
Vince & Associates Clinical Research, Inc.
Overland Park, Kansas, United States, 66212