2022
Exploratory investigation of a patient‐informed low‐dose psilocybin pulse regimen in the suppression of cluster headache: Results from a randomized, double‐blind, placebo‐controlled trial
Schindler E, Sewell R, Gottschalk C, Luddy C, Flynn L, Zhu Y, Lindsey H, Pittman B, Cozzi N, D'Souza D. Exploratory investigation of a patient‐informed low‐dose psilocybin pulse regimen in the suppression of cluster headache: Results from a randomized, double‐blind, placebo‐controlled trial. Headache The Journal Of Head And Face Pain 2022, 62: 1383-1394. PMID: 36416492, DOI: 10.1111/head.14420.Peer-Reviewed Original ResearchConceptsAttacks/weekPulse regimenCluster headachePsychotropic effectsAttack frequencyPlacebo-controlled studyPlacebo-controlled trialSerious adverse eventsEffects of psilocybinEffect sizeChronic participantsEfficacy outcomesAdverse eventsModerate effect sizeHeadache burdenHeadache disordersTherapeutic effectHeadache diaryPsilocybin administrationDrug sessionsExperimental drugsRegimenPsilocybin-containing mushroomsDefinitive studiesFinal analysis
2020
Exploratory Controlled Study of the Migraine-Suppressing Effects of Psilocybin
Schindler EAD, Sewell RA, Gottschalk CH, Luddy C, Flynn LT, Lindsey H, Pittman BP, Cozzi NV, D'Souza D. Exploratory Controlled Study of the Migraine-Suppressing Effects of Psilocybin. Neurotherapeutics 2020, 18: 534-543. PMID: 33184743, PMCID: PMC8116458, DOI: 10.1007/s13311-020-00962-y.Peer-Reviewed Original ResearchConceptsTherapeutic effectAdverse eventsSingle administrationPsychotropic effectsWeekly migraine daysSerious adverse eventsCross-over studyEffects of psilocybinOral placeboMigraine daysMigraine frequencyClinical effectsControlled StudyHeadache disordersMigraine headacheHeadache diaryDrug effectsDrug AdministrationNeuropsychiatric conditionsMigraineFinal analysisStudy proceduresReceptor ligandsWeeksAdministration
2018
Efficacy and safety of a fatty acid amide hydrolase inhibitor (PF-04457845) in the treatment of cannabis withdrawal and dependence in men: a double-blind, placebo-controlled, parallel group, phase 2a single-site randomised controlled trial
D'Souza DC, Cortes-Briones J, Creatura G, Bluez G, Thurnauer H, Deaso E, Bielen K, Surti T, Radhakrishnan R, Gupta A, Gupta S, Cahill J, Sherif MA, Makriyannis A, Morgan PT, Ranganathan M, Skosnik PD. Efficacy and safety of a fatty acid amide hydrolase inhibitor (PF-04457845) in the treatment of cannabis withdrawal and dependence in men: a double-blind, placebo-controlled, parallel group, phase 2a single-site randomised controlled trial. The Lancet Psychiatry 2018, 6: 35-45. PMID: 30528676, DOI: 10.1016/s2215-0366(18)30427-9.Peer-Reviewed Original ResearchConceptsPF-04457845Cannabis withdrawal symptomsFatty acid amide hydrolaseCannabis withdrawalPlacebo groupAdverse eventsCannabis useWithdrawal symptomsFatty acid amide hydrolase inhibitorSerious adverse eventsPhase 2a trialWeeks of treatmentTreatment of cannabisCannabis use disorderSelf-reported cannabis useDSM-IV criteriaTreatment-related differencesTHC-COOH concentrationsAnandamide concentrationsTreat populationPrimary endpointPill countHospital admissionNovel FAAH inhibitorsSelf-reported cannabis