MétaCan
Menu
Back to cohort
Record W2990457166 · doi:10.1002/jcph.1543

Abuse Potential of Lasmiditan: A Phase 1 Randomized, Placebo‐ and Alprazolam‐Controlled Crossover Study

2019· article· en· W2990457166 on OpenAlexaff
Darren Wilbraham, Paul H. Berg, Max Tsai, Emily Liffick, Li Shen Loo, Erin Doty, Edward M. Sellers

Bibliographic record

VenueThe Journal of Clinical Pharmacology · 2019
Typearticle
Languageen
FieldMedicine
TopicMigraine and Headache Studies
Canadian institutionsDe Beers (Canada)
FundersEli Lilly and Company
KeywordsAlprazolamPlaceboMedicineAdverse effectTolerabilityAnesthesiaInternal medicinePsychiatryAnxiety

Abstract

fetched live from OpenAlex

Abstract Lasmiditan is a centrally penetrant, highly selective 5‐hydroxytryptamine (serotonin) receptor 1F (5HT 1F ) agonist under development as a novel therapy for acute treatment of migraine. A phase 1 randomized, placebo‐ and positive‐controlled crossover study assessed the abuse potential of lasmiditan in adult recreational polydrug users. Following a qualification phase, subjects were randomized into treatment sequences, each consisting of 5 study treatments: placebo, alprazolam 2 mg, lasmiditan 100, 200 (lasmiditan 100 and 200 mg are proposed therapeutic doses), and 400 mg (supratherapeutic). The abuse potential of lasmiditan was investigated and compared with alprazolam and with placebo using the maximal effect score (E max ) of the Drug‐Liking Visual Analog Scale as the primary end point. Lasmiditan was not similar to placebo in drug‐liking scores at all doses tested, with a maximum difference observed with the lasmiditan 400‐mg dose (upper 90% confidence limit on difference in least‐squares [LS] means > 14 for all lasmiditan doses). Drug‐liking scores for lasmiditan 400 mg were not significantly different from alprazolam (lower 90% confidence limit on difference in LS means < 5), but drug‐liking scores at lower doses (100 and 200 mg) were significantly different from alprazolam. During the treatment phase, the incidence of treatment‐emergent adverse events (TEAEs) increased with increasing dose of lasmiditan; all TEAEs reported with lasmiditan treatment were mild. Subjective drug‐liking effects for lasmiditan versus placebo and versus alprazolam, and the safety and tolerability profile of lasmiditan suggest that lasmiditan has a low potential for abuse.

Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.

How this classification was reachedexpand

Full frame distilled prediction

Teacher imitation

Not calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.

metaresearch head score (Codex)0.009
metaresearch head score (Gemma)0.001
Version: codex-gemma-dda1882f352aValidation status: machine_predicted_unvalidated
Candidate categoriesInsufficient payload (model declined to judge)
Consensus categoriesnone
DomainCandidate signal: none · Consensus signal: none
Study designCandidate signal: Randomized trial · Consensus signal: Randomized trial
GenreCandidate signal: Empirical · Consensus signal: Empirical
Teacher disagreement score0.030
Threshold uncertainty score1.000

Codex and Gemma teacher scores by category

CategoryCodexGemma
Metaresearch0.0090.001
Meta-epidemiology (narrow)0.0000.000
Meta-epidemiology (broad)0.0030.001
Bibliometrics0.0000.000
Science and technology studies0.0000.000
Scholarly communication0.0000.000
Open science0.0000.000
Research integrity0.0000.001
Insufficient payload (model declined to judge)0.0010.000

Machine scores (provisional)

The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.

Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.

Opus teacher head0.039
GPT teacher head0.459
Teacher spread0.421 · how far apart the two teachers sit on this one work
Validation statusscore_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from it

Classification

machine, unvalidated

Machine predicted; a candidate call from one teacher head, not a consensus.

Study designRandomized trial
Domainnot available
GenreEmpirical

How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".

Quick stats

Citations29
Published2019
Admission routes1
Has abstractyes

Explore more

Same venueThe Journal of Clinical PharmacologySame topicMigraine and Headache StudiesFrench-language works237,207