Recreational Drug UsePhase 1NCT03286218

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

A Phase 1 study testing Lasmiditan and Alprazolam in people with Recreational Drug Use and Prescription Drug Abuse (Not Dependent), run by Eli Lilly and Company at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Recreational Drug Use, Prescription Drug Abuse (Not Dependent)
What is being tested?: Lasmiditan and Alprazolam
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 96 participants
Where: 1 siteUnited States
Study dates: 15 Sep 2017to 20 Nov 2017
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Vince & Associates Clinical Research, Inc.
Overland Park, Kansas, 66212

Other trials in United States

About this study

Official title: 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.

Conditions: Recreational Drug Use, Prescription Drug Abuse (Not Dependent)
Being tested: Lasmiditan, Alprazolam, Placebo
Medical subject headings: Recreational Drug Use, Substance-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LasmiditanDrug
Also called LY573144
Administered orally
AlprazolamDrug
Administered orally
PlaceboDrug
Administered orally

Study groups in NCT03286218
Study group	Role	What they receive
Placebo	Placebo comparator	Placebo was administered orally in one of five treatment periods Receives: Drug: Placebo
Alprazolam 2 milligram (mg)	Active comparator	2 mg of alprazolam was administered orally in one of five treatment periods Receives: Drug: Alprazolam
Lasmiditan 100 mg	Experimental	100 mg of lasmiditan was administered orally in one of five treatment periods Receives: Drug: Lasmiditan
Lasmiditan 200 mg	Experimental	200 mg of lasmiditan was administered orally in one of five treatment periods Receives: Drug: Lasmiditan
Lasmiditan 400 mg	Experimental	400 mg of lasmiditan was administered orally in one of five treatment periods Receives: Drug: Lasmiditan

What is being measured

The primary outcome is the main question the study is designed to answer.

Pharmacodynamics (PD): Maximal Effect Score (Emax) of Bipolar Drug Liking Visual Analog Scale (VAS) Scores
The Emax of Bipolar Drug Liking VAS Scores were derived as the maximum at-the-moment Drug Liking VAS score where the time to Emax was the corresponding time point at which the maximum score occurred. The bipolar Drug Liking VAS is consistent with FDA Guidance (January 2017) such that placebo should produce a score between 40 and 60 representing neutral drug-liking (ie, neither like nor dislike); a score ranging from 0 to 100 and a score of 0 indicates strong disliking, and a score of 100 indicates strong liking. Least squares mean (LS mean) was calculated using a linear mixed-effects model, including period, sequence, and treatment as fixed effects, and subject as a random effect, was used to evaluate the hypothesis tests of primary interest (at-the-moment Drug Liking) at the Emax.
Measured: Each Phase: 24 Hours

Secondary outcomes (6)

Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Lasmiditan
Pharmacokinetics (PK) defined as the maximum observed drug concentration (Cmax) of lasmiditan
Measured: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours Post Dose
PK: Area Under the Curve of Lasmiditan From Zero to Infinity (AUC[0-∞])
PK defined as the area under the curve of lasmiditan from zero to infinity (AUC[0-∞])
Measured: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours Post Dose
PD: Maximal Drug Effects (Emax) Visual Analog Scale (VAS)
Drug Effects VAS Battery lists a series of measures that evaluate different effects of the abuse potential of the study drug. Scales include: Overall drug liking (overall, my liking for this drug is) and ranges from 0 definitely not to 100 definitely so. Take Drug Again (I would take this drug again) and ranges from 0 definitely not to 100 definitely so. Good effects (I can feel good drug effects) and ranges from 0 definitely not to 100 definitely so. Bad effects (I can feel bad drug effects) and ranges from 0 definitely not to 100 definitely so. High (I am feeling) and ranges from 0 not at all high to 100 extremely high. Emax is derived as the maximum score across all postdose time points for each participant. Least Square (LS) Mean is calculated using the linear mixed-effects model with period, sequence and treatment as fixed effects and participant as a random effect.
Measured: Each Phase: Predose, 0.25, 0.5, 1, 1.5, 2, 2.5,3, 3.5, 4, 4.5, 5, 6, 8, 12, 24 Hours Post Dose
PD: Maximal Drug Effects (Emax) VAS (Hallucinations)
Drug Effects VAS Battery lists a series of measures that evaluate different effects of the abuse potential of the study drug. The hallucinations scale is presented meaning (I am hallucinating) and ranges from 0 not at all to 100 extremely. Emax is derived as the maximum score across all postdose time points for each participant. Median and interquartile range are reported for each treatment group.
Measured: Each Phase: Predose, 0.25, 0.5, 1, 1.5, 2, 2.5,3, 3.5, 4, 4.5, 5, 6, 8, 12, 24 Hours Post Dose
PD: Minimum Drug Effects (Emin) Visual Analog Scale (VAS)
Drug Effects VAS Battery lists a series of measures that evaluate different effects of the abuse potential of the study drug. The scales included: Alertness/Drowsiness (I am feeling) ranges from 0 very drowsy to 100 very alert. Agitation/Relaxation (my mood is) and ranges from 0 very relaxed to 100 very agitated. Emin is derived across all postdose time points for each participant. LS Mean was calculated using the linear mixed-effects model with period, sequence and treatment as fixed effects and participant as a random effect.
Measured: Each Phase:Predose, 0.25, 0.5, 1, 1.5, 2, 2.5,3, 3.5, 4, 4.5, 5, 6, 8, 12, 24 Hours Post Dose
PD: Mean Scores on Drug Similarity VAS Measures
Participants marked a point on a 100-mm horizontal line that best represented their response to the given question. The endpoints of each electronic scale were marked with descriptive anchors on a scale from 0 to 100 (Fraser et al. 1961; Bond and Lader 1974; Bigelow 1991; Shram et al. 2010). In the "How similar" questions, ranges from 0 to 100 and a score of 0 indicates definitely not similar, and a score of 100 indicates definitely similar.
Measured: Each Phase: 24 Hours Post Dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Sep 201720 Nov 2017

First posted18 Sep 2017
Study start15 Sep 2017
Primary completion20 Nov 2017
Study completion20 Nov 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Recreational Drug UseStudies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 96 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03286218
Sponsor's protocol ID: 16853
Other IDs: H8H-MC-LAHB
Status last verified: Dec 2017
First submitted: 15 Sep 2017
Last updated: 10 Jan 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 10 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Subject- and Investigator-Blind, Placebo and Active-Controlled Study to Assess the Abuse Potential of Lasmiditan
ClinicalTrials.gov ID: NCT03286218
Acronym / sponsor ID: 16853
Conditions: Recreational Drug Use, Prescription Drug Abuse (Not Dependent)
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 96 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: 15 Sep 2017 (actual)
Primary completion: 20 Nov 2017 (actual)
Study completion: 20 Nov 2017 (actual)
First posted: 18 Sep 2017 (actual)
Results: Posted 10 Jan 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to assess the abuse potential of study drug lasmiditan.

This study will last about 55 days, including screening. Screening will occur within 28 days prior to qualification phase.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 5

Arm	Type	Receives
Placebo	Placebo comparator	Drug: PlaceboPlacebo was administered orally in one of five treatment periods
Alprazolam 2 milligram (mg)	Active comparator	Drug: Alprazolam2 mg of alprazolam was administered orally in one of five treatment periods
Lasmiditan 100 mg	Experimental	Drug: Lasmiditan100 mg of lasmiditan was administered orally in one of five treatment periods
Lasmiditan 200 mg	Experimental	Drug: Lasmiditan200 mg of lasmiditan was administered orally in one of five treatment periods
Lasmiditan 400 mg	Experimental	Drug: Lasmiditan400 mg of lasmiditan was administered orally in one of five treatment periods

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (6 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LasmiditanAlso: LY573144Administered orally	Drug	Lasmiditan 100 mg, Lasmiditan 200 mg, Lasmiditan 400 mg
AlprazolamAdministered orally	Drug	Alprazolam 2 milligram (mg)
PlaceboAdministered orally	Drug	Placebo

Primary outcome

Pharmacodynamics (PD): Maximal Effect Score (Emax) of Bipolar Drug Liking Visual Analog Scale (VAS) Scores
Time frame: Each Phase: 24 Hours
The Emax of Bipolar Drug Liking VAS Scores were derived as the maximum at-the-moment Drug Liking VAS score where the time to Emax was the corresponding time point at which the maximum score occurred. The bipolar Drug Liking VAS is consistent with FDA Guidance (January 2017) such that placebo should produce a score between 40 and 60 representing neutral drug-liking (ie, neither like nor dislike); a score ranging from 0 to 100 and a score of 0 indicates strong disliking, and a score of 100 indicates strong liking. Least squares mean (LS mean) was calculated using a linear mixed-effects model, including period, sequence, and treatment as fixed effects, and subject as a random effect, was used to evaluate the hypothesis tests of primary interest (at-the-moment Drug Liking) at the Emax.

6 secondary outcomes

Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Lasmiditan
Time frame: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours Post Dose
PK: Area Under the Curve of Lasmiditan From Zero to Infinity (AUC[0-∞])
Time frame: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours Post Dose
PD: Maximal Drug Effects (Emax) Visual Analog Scale (VAS)
Time frame: Each Phase: Predose, 0.25, 0.5, 1, 1.5, 2, 2.5,3, 3.5, 4, 4.5, 5, 6, 8, 12, 24 Hours Post Dose
PD: Maximal Drug Effects (Emax) VAS (Hallucinations)
Time frame: Each Phase: Predose, 0.25, 0.5, 1, 1.5, 2, 2.5,3, 3.5, 4, 4.5, 5, 6, 8, 12, 24 Hours Post Dose
PD: Minimum Drug Effects (Emin) Visual Analog Scale (VAS)
Time frame: Each Phase:Predose, 0.25, 0.5, 1, 1.5, 2, 2.5,3, 3.5, 4, 4.5, 5, 6, 8, 12, 24 Hours Post Dose
PD: Mean Scores on Drug Similarity VAS Measures
Time frame: Each Phase: 24 Hours Post Dose

Results and safety

Results posted to the registry on 10 Jan 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Qualification Phase - Alprazolam Then Placebo Sequence 1	48	47
Qualification Phase - Placebo Then Alprazolam (Alp) Sequence 2	48	47
Sequence 1	0	0
Sequence 2	0	0
Sequence 3	0	0
Sequence 4	0	0
Sequence 5	0	0
Sequence 6	0	0
Sequence 7	0	0
Sequence 8	0	0
Sequence 9	0	0
Sequence 10	0	0

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

Time frame: Each Phase: 24 Hours. Least squares mean (Standard Error). Unit: millimeter (mm)

Measure	Placebo n = 53	Alprazolam - 2 mg n = 53	Lasmiditan - 100 mg n = 53	Lasmiditan - 200 mg n = 53	Lasmiditan - 400 mg n = 53
Value	53.0 (1.94)	85.4 (1.94)	68.6 (1.94)	73.3 (1.94)	76.6 (1.94)

Placebo vs Alprazolam - 2 mg: Least Squares (LS) Mean Difference: 32.4 (90% CI 28.4 to 36.4)
Placebo vs Lasmiditan - 100 mg: LS Mean Difference: 15.6 (90% CI 11.7 to 19.6)
Placebo vs Lasmiditan - 200 mg: LS Mean Difference: 20.3 (90% CI 16.3 to 24.3)

Population analysed: All randomized participants who received at least one dose of study drug had evaluable PD data in each of the 5 periods.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: From Baseline to Study Completion (Up to 2 months). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Qualification Phase - Placebo	0 of 95 (0%)	8 of 95 (8.4%)	0 of 95
Qualification Phase - Alprazolam	0 of 94 (0%)	74 of 94 (78.7%)	0 of 94
Treatment Phase - Placebo	0 of 55 (0%)	12 of 55 (21.8%)	0 of 55
Treatment Phase - 2 mg Alprazolam	0 of 53 (0%)	49 of 53 (92.5%)	0 of 53
Treatment Phase - 100 mg Lasmiditan	0 of 55 (0%)	33 of 55 (60%)	0 of 55
Treatment Phase - 200 mg Lasmiditan	0 of 55 (0%)	42 of 55 (76.4%)	0 of 55
Treatment Phase - 400 mg Lasmiditan	0 of 55 (0%)	47 of 55 (85.5%)	0 of 55

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director

Eli Lilly and Company

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Lasmiditan and Alprazolam in people with Recreational Drug Use and Prescription Drug Abuse (Not Dependent), run by Eli Lilly and Company at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pharmacodynamics (PD): Maximal Effect Score (Emax) of Bipolar Drug Liking Visual Analog Scale (VAS) Scores (time frame: Each Phase: 24 Hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03286218.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2020.