A Study of the Abuse Potential of Lasmiditan in Participa... | NCT03286218

ID	Type	Description	Link
H8H-MC-LAHB	Other Identifier	Eli Lilly and Company

A Study of the Abuse Potential of Lasmiditan in Participa... | NCT03286218 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator	Placebo was administered orally in one of five treatment periods	Drug: Placebo
Alprazolam 2 milligram (mg)	Active Comparator	2 mg of alprazolam was administered orally in one of five treatment periods	Drug: Alprazolam
Lasmiditan 100 mg	Experimental	100 mg of lasmiditan was administered orally in one of five treatment periods	Drug: Lasmiditan
Lasmiditan 200 mg	Experimental	200 mg of lasmiditan was administered orally in one of five treatment periods	Drug: Lasmiditan
Lasmiditan 400 mg	Experimental	400 mg of lasmiditan was administered orally in one of five treatment periods	Drug: Lasmiditan

Name	Type	Description	Arm Group Labels	Other Names
Lasmiditan	Drug	Administered orally	Lasmiditan 100 mg Lasmiditan 200 mg Lasmiditan 400 mg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	Each Phase: 24 Hours

Secondary Outcomes

Measure	Description	Time Frame
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Lasmiditan	Pharmacokinetics (PK) defined as the maximum observed drug concentration (Cmax) of lasmiditan	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-∞])

Contacts/Locations Module

Name	Affiliation	Role
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)	Eli Lilly and Company	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Vince & Associates Clinical Research, Inc.		Overland Park	Kansas	66212	United States

Arm/Group Information

ID	Title	Description
FG000	Qualification Phase - Alprazolam Then Placebo Sequence 1	Sequence 1 - One tablet of 1 milligram (mg) alprazolam was administered orally in period 1 then placebo period 2.
FG001	Qualification Phase - Placebo Then Alprazolam (Alp) Sequence 2	Sequence 2 - Placebo was administered orally period 1 then one tablet of 2 mg alprazolam period 2.
FG002	Sequence 1	Sequence 1, Periods 1 - 5: (Placebo, 100 mg Las, 2 mg Alp, 200 mg Las, then 400 mg Las) All participants received: Period 1: Placebo Period 2: 100 mg Las Period 3: 200 mg Las Period 4: 400 mg Las Period 5: 2 mg Alp Orally with a 3 day washout between doses.
FG003	Sequence 2	Sequence 2 , Periods 1 - 5: (100 mg Las, 200 mg Las, Placebo, 400 mg Las, then 2 mg Alp) All participants received: Period 1: 100 mg Las Period 2: 200 mg Las Period 3: Placebo Period 4: 400 mg Las Period 5: 2 mg Alp Orally with a 3 day washout between doses.
FG004	Sequence 3	Sequence 3, Periods 1 - 5: (200 mg Las, 400 mg Las, 100 mg Las, 2 mg Alp, then Placebo) All participants received: Period 1: 200 mg Las Period 2: 400 mg Las Period 3: 100 mg Las Period 4: 2 mg Las Period 5: Placebo Orally with a 3 day washout between doses.
FG005	Sequence 4	Sequence 4, Periods 1 - 5: (400 mg Las, 2 mg Alp, 200 mg Las, Placebo, then 100 mg Las) All participants received: Period 1: 400 mg Las Period 2: 2 mg Alp Period 3: 200 mg Las Period 4: Placebo Period 5: 100 mg Las Orally with a 3 day washout between doses.
FG006	Sequence 5	Sequence 5, Periods 1 - 5: (2 mg Alp, Placebo, 400 mg Las, then 200 mg Las) All participants received: Period 1: 2 mg Alp Period 2: Placebo Period 3: 400 mg Las Period 4: 200 mg Las Period 5: 100 mg Las Orally with a 3 day washout between doses.
FG007	Sequence 6	Sequence 6, Periods 1 - 5 (400 mg Las, 200 mg Las, 2 mg Alp, 100 mg Las, then Placebo) All participants received: Period 1: 400 mg Las Period 2: 200 mg Las Period 3: 2 mg Alp Period 4: 100 mg Las Period 5: Placebo Orally with a 3 day washout between doses.
FG008	Sequence 7	Sequence 7, Periods 1-5: (2 mg Alp, 400 mg Las, Placebo, 200 mg Las, then 100 mg Las) All participants received: Period 1: 2 mg Alp Period 2: 400 mg Las Period 3: Placebo Period 4: 200 mg Las Period 5: 100 mg Las Orally with a 3 day washout between doses.
FG009	Sequence 8	Sequence 8, Periods 1 - 5: Placebo, 2 mg Lap, 100 mg Las, 400 mg Las, then 200 mg Las) All participants received: Period 1: Placebo Period 2: 2 mg Las Period 3: 100 mg Las Period 4: 400 mg Las Period 5: 200 mg Las Orally with a 3 day washout between doses.
FG010	Sequence 9	Sequence 9, Periods 1 - 5: (100 mg Las, Placebo, 200 mg Las, 2 mg Alp, 400 mg Las) All participants received: Period 1: 100 mg Las Period 2: Placebo Period 3: 200 mg Las Period 4: 2 mg Alp Period 5: 400 mg Las Orally with a 3 day washout between doses.
FG011	Sequence 10	Sequence 10, Periods 1 - 5: (200 mg Las, 100 mg Las, 400 mg Las, Placebo, then 2 mg Alp) All participants received: Period 1: 200 mg Las Period 2: 100 mg Las Period 3: 400 mg Las Period 4: Placebo Period 5: 2 mg Alp Orally with a 3 day washout between doses.

Periods

Title

Milestones

Reasons Not Completed

Qualification Phase Period 1

Type	Comment	Milestone Data
STARTED		FG00048 subjects FG00148 subjects FG0020 subjects FG0030 subjects FG004
Received at Least One Dose of Study Drug		FG00047 subjects FG00147 subjects FG0020 subjects FG0030 subjects
COMPLETED		FG00047 subjects FG00147 subjects FG0020 subjects FG0030 subjects FG004
NOT COMPLETED		FG0001 subjects FG0011 subjects FG0020 subjects FG0030 subjects FG004

Type	Comment	Reasons
Adverse Event		FG0001 subjects FG0010 subjects FG0020 subjects FG003

Qualification Phase Period 2

Type	Comment	Milestone Data
STARTED		FG00047 subjects FG00147 subjects FG0020 subjects FG003

Treatment Phase Period 1

Type	Comment	Milestone Data
STARTED		FG0000 subjectsParticipants completed the Qualification Phase prior to entering the Treatment Phase. FG0010 subjectsParticipants completed the Qualification Phase prior to entering the Treatment Phase. FG0026 subjectsParticipants completed the Qualification Phase and crossed over to the Treatment Phase. FG003

Treatment Phase Period 2

Type	Comment	Milestone Data
STARTED		FG0000 subjects FG0010 subjects FG0025 subjects FG003

Treatment Phase Period 3

Type	Comment	Milestone Data
STARTED		FG0000 subjects FG0010 subjects FG0025 subjects FG003

Treatment Phase Period 4

Type	Comment	Milestone Data
STARTED		FG0000 subjects FG0010 subjects FG0025 subjects FG003

Treatment Phase Period 5

Type	Comment	Milestone Data
STARTED		FG0000 subjects FG0010 subjects FG0025 subjects FG003

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Overall Participants	All participants received one dose of alprazolam and placebo in the qualification phase and participants received at least one dose lasmiditan, alprazolam and/or placebo in the treatment phase.

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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.

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

Posted

Least Squares Mean

Standard Error

millimeter (mm)

Each Phase: 24 Hours

ID	Title	Description

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Qualification Phase - Placebo	Placebo was administered orally.	0

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Feeling of relaxation	General disorders	MedDRA 20.0	Systematic Assessment

More Info Module

Certain Agreements

Title	Organization	Phone	Extension	Email
Chief Medical Officer	Eli Lilly and Company	(800) 545-5979		ClinicalTrials.gov@lilly.com

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Sep 5, 2017	Nov 5, 2018	Prot_000.pdf
SAP	No	Yes	No	Statistical Analysis Plan	Sep 11, 2017	Nov 5, 2018	SAP_001.pdf

Condition Browse Module

ID	Term
D000084783	Recreational Drug Use
D019966	Substance-Related Disorders

ID	Term
D001519	Behavior
D064419	Chemically-Induced Disorders
D001523	Mental Disorders

Intervention Browse Module

ID	Term
C554777	lasmiditan
D000525	Alprazolam

ID	Term
D001569	Benzodiazepines
D001552	Benzazepines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring

Type	Comment	Reasons
Adverse Event		FG0000 subjects FG0011 subjects FG0020 subjects FG0030 subjects FG0040 subjects FG0050 subjects FG0060 subjects FG0070 subjects FG0080 subjects FG0090 subjects FG0100 subjects FG0110 subjects
Failure to meet randomization criteria		FG00014 subjects FG00115 subjects FG0020 subjects FG0030 subjects FG004
Lost to Follow-up		FG0000 subjects FG0011 subjects FG0020 subjects FG0030 subjects FG004
Protocol Violation		FG0002 subjects FG0010 subjects FG0020 subjects FG0030 subjects FG004
Withdrawal by Subject		FG0001 subjects FG0012 subjects FG0020 subjects FG0030 subjects FG004

Type	Comment	Reasons
Withdrawal by Subject		FG0000 subjects FG0010 subjects FG0021 subjects FG0031 subjects FG0040 subjects FG0051 subjects FG0060 subjects FG0070 subjects FG0080 subjects FG0090 subjects FG0100 subjects FG0111 subjects

Type	Comment	Reasons
Withdrawal by Subject		FG0000 subjects FG0010 subjects FG0020 subjects FG0030 subjects FG0040 subjects FG0050 subjects FG0060 subjects FG0070 subjects FG0080 subjects FG0090 subjects FG0100 subjects FG0111 subjects

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0001
Asian	BG0000
Native Hawaiian or Other Pacific Islander	BG0001
Black or African American	BG00069
White	BG00024
More than one race	BG0001
Unknown or Not Reported	BG0000

Group IDs	Parameter Type	Parameter Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Non-Inferiority Type	Non-Inferiority Comment
OG000 OG001	Least Squares (LS) Mean Difference	32.4	2-Sided	90	28.4	36.4	Non-Inferiority	The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 14 mm.
OG000 OG002	LS Mean Difference	15.6	2-Sided	90	11.7	19.6	Non-Inferiority	The non-inferiority (NI) margin for Lasmiditan doses vs Placebo is 14 mm.
OG000 OG003	LS Mean Difference	20.3	2-Sided	90	16.3	24.3	Non-Inferiority	The non-inferiority (NI) margin for Lasmiditan doses vs Placebo is 14 mm.
OG000 OG004	LS Mean Difference	23.6	2-Sided	90	19.6	27.6	Non-Inferiority	The non-inferiority (NI) margin for Lasmiditan doses vs Placebo is 14 mm.
OG001 OG002	LS Mean Difference	16.8	2-Sided	90	12.8	20.8	Non-Inferiority	The non-inferiority (NI) margin for Alprazolam and Lasmiditan 100 mg dose is 5 mm.
OG001 OG003	LS Mean Difference	12.1	2-Sided	90	8.10	16.1	Non-Inferiority	The non-inferiority (NI) margin for Alprazolam and Lasmiditan 200 mg dose is 5 mm.
OG001 OG004	LS Mean Difference	8.79	2-Sided	90	4.8	12.8	Non-Inferiority	The non-inferiority (NI) margin for Alprazolam and Lasmiditan 400 mg dose is 5 mm.

Secondary

Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Lasmiditan

Pharmacokinetics (PK) defined as the maximum observed drug concentration (Cmax) of lasmiditan

All randomized participants who received at least one dose of study drug and had evaluable PK data.

Posted

Geometric Mean

Geometric Coefficient of Variation

nanogram/milliliter (ng/mL)

Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours Post Dose

ID	Title	Description
OG000	Lasmiditan - 100 mg	100 mg of lasmiditan administered orally in one of five treatment periods
OG001	Lasmiditan - 200 mg	200 of lasmiditan administered orally in one of five treatment periods
OG002	Lasmiditan - 400 mg	400 mg of lasmiditan administered orally in one of five treatment periods

Units	Counts
Participants	OG00055 OG00155 OG00255

Title

Denominators

Categories

Title	Measurements
	OG000132± 37 OG001299± 35 OG002689± 34

Secondary

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-∞])

All randomized participants who received at least one dose of study drug and had evaluable PK data.

Posted

Geometric Mean

Geometric Coefficient of Variation

nanogram*hour/milliliter (ng*h/mL)

Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours Post Dose

ID	Title	Description
OG000	Lasmiditan - 100 mg	100 mg lasmiditan administered orally in one of five treatment periods
OG001	Lasmiditan - 200 mg	200 mg of lasmiditan administered orally in one of five treatment periods
OG002	Lasmiditan - 400 mg Dose	400 of lasmiditan administered orally in one of five treatment periods

Units	Counts
Participants	OG00055 OG00155 OG00255

Title

Denominators

Categories

Title	Measurements
	OG000856± 32 OG0011810± 35 OG0023920± 28

Secondary

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.

All randomized participants who received at least one dose of study drug and had evaluable PD data, and completed the study.

Posted

Least Squares Mean

Standard Error

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

ID	Title	Description
OG000	Placebo	Placebo was administered orally in one of five treatment periods.
OG001	Alprazolam - 2 mg	2 mg of Alprazolam administered orally in one of five treatment periods
OG002	Lasmiditan - 100 mg	100 mg of lasmiditan administered orally in one of five treatment periods
OG003	Lasmiditan - 200 mg	200 mg of lasmiditan administered orally in one of five treatment periods
OG004	Lasmiditan - 400 mg	400 mg of lasmiditan administered orally in one of five treatment periods

Units	Counts
Participants	OG00053 OG00153 OG00253 OG003

Title

Denominators

Categories

Overall Drug Liking

Title	Measurements
	OG00053.1± 2.41 OG00186.2± 2.41 OG00271.7± 2.41 OG003

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Overall Drug Liking					LS Mean Difference	33.1			2-Sided	90	28.5	37.7					Other
OG000 OG002	Overall Drug Liking

Secondary

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.

All randomized participants who received at least one dose of study drug and had evaluable PD data, and completed the study.

Posted

Median

Inter-Quartile Range

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

ID	Title	Description
OG000	Placebo	Placebo was administered orally in one of five treatment periods.
OG001	Alprazolam - 2 mg	2 mg of Alprazolam administered orally in one of five treatment periods
OG002	Lasmiditan - 100 mg	100 mg of lasmiditan administered orally in one of five treatment periods
OG003	Lasmiditan - 200 mg	200 mg of lasmiditan administered orally in one of five treatment periods
OG004	Lasmiditan - 400 mg	400 mg of lasmiditan administered orally in one of five treatment periods

Units	Counts
Participants	OG00053 OG00153 OG00253 OG003

Title

Denominators

Categories

Title	Measurements
	OG0000(0 to 0) OG0010(0 to 1.00) OG0020(0 to 0) OG003

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Wilcoxon (Mann-Whitney)		<0.0001		Mean Difference (Final Values)	0			2-Sided								Superiority
OG000 OG002		Wilcoxon (Mann-Whitney)		0.0781

Secondary

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.

All randomized participants who received at least one dose of study drug and had evaluable PD data, and completed the study.

Posted

Least Squares Mean

Standard Error

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

ID	Title	Description
OG000	Placebo	Placebo was administered orally in one of five treatment periods.
OG001	Alprazolam - 2 mg	2 mg of Alprazolam administered orally in one of five treatment periods
OG002	Lasmiditan - 100 mg	100 mg of lasmiditan administered orally in one of five treatment periods
OG003	Lasmiditan - 200 mg	200 mg of lasmiditan administered orally in one of five treatment periods
OG004	Lasmiditan - 400 mg	400 mg of lasmiditan administered orally in one of five treatment periods

Units	Counts
Participants	OG00053 OG00153 OG00253 OG003

Title

Denominators

Categories

Alertness/drowsiness

Title	Measurements
	OG00042.5± 1.97 OG00112.5± 1.97 OG00225.6± 1.97 OG003

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Alertness/drowsiness					LS Mean Difference	-29.9			2-Sided	90	-34.0	-25.9					Other
OG000 OG002	Alertness/drowsiness

Secondary

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.

All randomized participants who received at least one dose of study drug, were familiar with each listed drug on the questionnaire and had evaluable data.

Posted

Mean

Standard Deviation

score on a scale

Each Phase: 24 Hours Post Dose

ID	Title	Description
OG000	Placebo - Qualification Phase	Placebo was administered orally in one of 2 treatment periods.
OG001	1 mg Alprazolam - Qualification Phase	1 mg of Alprazolam was administered orally in one of 2 treatment periods.
OG002	Placebo	Placebo was administered orally in one of five treatment periods.
OG003	2 mg Alprazolam	2 mg of Alprazolam was administered orally in one of five treatment periods.
OG004	Lasmiditan - 100 mg	100 mg of lasmiditan administered orally in one of five treatment periods
OG005	Lasmiditan - 200 mg	200 mg of lasmiditan administered orally in one of five treatment periods
OG006	Lasmiditan - 400 mg	400 mg of lasmiditan administered orally in one of five treatment periods

Units	Counts
Participants	OG00095 OG00194 OG00255 OG003

Title	Denominators	Categories
How similar with cocaine /	ParticipantsOG00050 ParticipantsOG00151 ParticipantsOG00228 ParticipantsOG003

How similar with caffeine

- ParticipantsOG00074
- ParticipantsOG00173
- ParticipantsOG00243
- ParticipantsOG00342
- ParticipantsOG00444
- ParticipantsOG00544
- ParticipantsOG00643

Title	Measurements
	OG0002.9± 10.3 OG0013.2± 6.0 OG0021.5± 7.2 OG003

How similar to MDMA (Ectasy)

- ParticipantsOG00031
- ParticipantsOG00131
- ParticipantsOG00218
- ParticipantsOG00317
- ParticipantsOG00417
- ParticipantsOG00518
- ParticipantsOG00617

Title	Measurements
	OG0004.7± 13.5 OG00110.0± 20.4 OG0021.4± 3.9 OG003

How similar to amphetamine or methamphetamine

- ParticipantsOG00024
- ParticipantsOG00124
- ParticipantsOG00216
- ParticipantsOG00315
- ParticipantsOG00416
- ParticipantsOG00517
- ParticipantsOG00616

Title	Measurements
	OG0001.5± 5.4 OG0014.3± 6.3 OG0022.4± 6.0 OG003

How similar to phencyclidine (PCP)

- ParticipantsOG0003
- ParticipantsOG0014
- ParticipantsOG0023
- ParticipantsOG0033
- ParticipantsOG0043
- ParticipantsOG0053
- ParticipantsOG0063

Title	Measurements
	OG00022.0± 30.6 OG0010.5± 1.0 OG0020.0± 0.0 OG003

How similar to codeine or morphine use

- ParticipantsOG00083
- ParticipantsOG00182
- ParticipantsOG00249
- ParticipantsOG00347
- ParticipantsOG00449
- ParticipantsOG00549
- ParticipantsOG00649

Title	Measurements
	OG00011.4± 23.8 OG00141.5± 35.1 OG0028.1± 21.7 OG003

How similar to (lysergic acid diethylamide (LSD)

- ParticipantsOG00011
- ParticipantsOG00112
- ParticipantsOG0026
- ParticipantsOG0036
- ParticipantsOG0046
- ParticipantsOG0057
- ParticipantsOG0066

Title	Measurements
	OG0001.2± 3.9 OG0014.1± 6.9 OG0024.2± 6.6 OG003

How similar to nicotine

- ParticipantsOG00077
- ParticipantsOG00176
- ParticipantsOG00244
- ParticipantsOG00342
- ParticipantsOG00444
- ParticipantsOG00543
- ParticipantsOG00644

Title	Measurements
	OG0002.9± 11.8 OG0015.1± 9.6 OG0021.4± 5.5 OG003

How similar to cannabis

- ParticipantsOG00092
- ParticipantsOG00191
- ParticipantsOG00253
- ParticipantsOG00351
- ParticipantsOG00453
- ParticipantsOG00553
- ParticipantsOG00653

Title	Measurements
	OG00010.8± 24.7 OG00139.9± 33.5 OG0028.9± 22.9 OG003

How similar to benzodiazepine

- ParticipantsOG00094
- ParticipantsOG00193
- ParticipantsOG00255
- ParticipantsOG00353
- ParticipantsOG00455
- ParticipantsOG00555
- ParticipantsOG00655

Title	Measurements
	OG00014.4± 32.4 OG00175.9± 36.2 OG00213.1± 30.6 OG003

How similar to mushrooms

- ParticipantsOG00014
- ParticipantsOG00115
- ParticipantsOG0027
- ParticipantsOG0037
- ParticipantsOG0047
- ParticipantsOG0058
- ParticipantsOG0067

Title	Measurements
	OG0000.0± 0.0 OG0012.7± 3.8 OG0022.1± 5.2 OG003

How similar to heroin

- ParticipantsOG0004
- ParticipantsOG0015
- ParticipantsOG0022
- ParticipantsOG0032
- ParticipantsOG0042
- ParticipantsOG0052
- ParticipantsOG0062

Title	Measurements
	OG0000.0± 0.0 OG00117.8± 38.1 OG002NA± NAMean and standard deviation are not calculated due to N=2, minimum and maximum values are reported: minimum value is 0 and maximum value is 0. OG003