2024
Psilocybin pulse regimen reduces cluster headache attack frequency in the blinded extension phase of a randomized controlled trial
Schindler E, Sewell R, Gottschalk C, Flynn L, Zhu Y, Pittman B, Cozzi N, D'Souza D. Psilocybin pulse regimen reduces cluster headache attack frequency in the blinded extension phase of a randomized controlled trial. Journal Of The Neurological Sciences 2024, 460: 122993. PMID: 38581739, DOI: 10.1016/j.jns.2024.122993.Peer-Reviewed Original ResearchConceptsAttack frequencyCluster headacheCluster headache attack frequencyExtension phaseEffects of repeated treatmentReduction of attack frequencyPlacebo-controlled studyHeadache attack frequencyAdministration of psilocybinRandomized controlled trialsDouble-blindPsilocybin administrationPulse regimenAdverse eventsPulse regimensHeadache diaryTherapeutic efficacyDrug sessionsPulse administrationHeadacheStudy participantsWeeks
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 analysisExploratory study of the dose-related safety, tolerability, and efficacy of dimethyltryptamine (DMT) in healthy volunteers and major depressive disorder
D’Souza D, Syed SA, Flynn LT, Safi-Aghdam H, Cozzi NV, Ranganathan M. Exploratory study of the dose-related safety, tolerability, and efficacy of dimethyltryptamine (DMT) in healthy volunteers and major depressive disorder. Neuropsychopharmacology 2022, 47: 1854-1862. PMID: 35660802, PMCID: PMC9372173, DOI: 10.1038/s41386-022-01344-y.Peer-Reviewed Original ResearchConceptsMajor depressive disorderHealthy controlsAntidepressant effectsDosing sessionsPsychotomimetic effectsDepressive disorderAbuse liabilityTreatment-resistant major depressive disorderDose-related safetyTreatment-resistant individualsMDD participantsPhase 1 studyHAMD-17 scoresTreatment of depressionFurther rigorous trialsMin of injectionExploratory pilot studyPsychedelic drugsAdverse eventsBlood pressureHAMD-17Cardiovascular functionRigorous trialsHealthy volunteersHeart rate
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
2013
Spicing things up: synthetic cannabinoids
Spaderna M, Addy PH, D’Souza D. Spicing things up: synthetic cannabinoids. Psychopharmacology 2013, 228: 525-540. PMID: 23836028, PMCID: PMC3799955, DOI: 10.1007/s00213-013-3188-4.Peer-Reviewed Original Research
2011
The safety of studies with intravenous Δ9-tetrahydrocannabinol in humans, with case histories
Carbuto M, Sewell RA, Williams A, Forselius-Bielen K, Braley G, Elander J, Pittman B, Schnakenberg A, Bhakta S, Perry E, Ranganathan M, D’Souza D, The Yale THC Study Group. The safety of studies with intravenous Δ9-tetrahydrocannabinol in humans, with case histories. Psychopharmacology 2011, 219: 885-896. PMID: 21845389, DOI: 10.1007/s00213-011-2417-y.Peer-Reviewed Original ResearchConceptsAdverse eventsPost-study periodCareful subject selectionMinor adverse eventsPhysical adverse eventsFrequent side effectsLong-term followCannabinoid receptor systemFaster infusion rateCannabinoid receptor ligandsIntravenous THCPlacebo infusionCannabinoid systemInfusion rateStudy participationSide effectsAbuse liabilityHigh dosesReceptor systemΔ9-tetrahydrocannabinolInfusionPsychoactive effectsReceptor ligandsTest daySubjects
2010
Armodafinil as adjunctive therapy in adults with cognitive deficits associated with schizophrenia: a 4-week, double-blind, placebo-controlled study.
Kane JM, D'Souza DC, Patkar AA, Youakim JM, Tiller JM, Yang R, Keefe RS. Armodafinil as adjunctive therapy in adults with cognitive deficits associated with schizophrenia: a 4-week, double-blind, placebo-controlled study. The Journal Of Clinical Psychiatry 2010, 71: 1475-81. PMID: 20816042, DOI: 10.4088/jcp.09m05950gry.Peer-Reviewed Original ResearchMeSH KeywordsAdultAntipsychotic AgentsBenzhydryl CompoundsBenzodiazepinesCentral Nervous System StimulantsCognition DisordersDouble-Blind MethodDrug Therapy, CombinationFemaleHumansIsoxazolesMaleMiddle AgedModafinilOlanzapinePaliperidone PalmitatePsychiatric Status Rating ScalesPyrimidinesRisperidoneSchizophreniaTreatment OutcomeConceptsAdjunctive armodafinilAdjunctive therapyFinal visitNegative symptomsTotal scoreIsomer of modafinilTolerability of armodafinilPlacebo-controlled studyPrimary efficacy measureSecondary outcome measuresPANSS total scoreSANS total scoreNegative symptom scoresNegative Syndrome ScaleDaily placeboStable dosesAdverse eventsOral risperidoneSymptom scoresEfficacy measuresSchizophrenia (MATRICS) Consensus Cognitive BatteryOutcome measuresStable schizophreniaSD changeArmodafinil
2005
Delta-9-tetrahydrocannabinol effects in schizophrenia: Implications for cognition, psychosis, and addiction
D’Souza D, Abi-Saab WM, Madonick S, Forselius-Bielen K, Doersch A, Braley G, Gueorguieva R, Cooper TB, Krystal JH. Delta-9-tetrahydrocannabinol effects in schizophrenia: Implications for cognition, psychosis, and addiction. Biological Psychiatry 2005, 57: 594-608. PMID: 15780846, DOI: 10.1016/j.biopsych.2004.12.006.Peer-Reviewed Original ResearchMeSH KeywordsAdultAkathisia, Drug-InducedArousalCognitionDose-Response Relationship, DrugDouble-Blind MethodDronabinolEndocrine SystemFemaleHumansInjections, IntravenousMaleMental RecallMiddle AgedMotor ActivityNeuropsychological TestsPerceptionPsychiatric Status Rating ScalesPsychotic DisordersPsychotropic DrugsSchizophreniaVerbal LearningConceptsSchizophrenia patientsAntipsychotic-treated schizophrenia patientsDelta-9-tetrahydrocannabinol effectsLong-term adverse eventsCognitive deficitsPlacebo-controlled studyDelta-9-THCTransient exacerbationAdverse eventsReceptor dysfunctionEndocrine effectsHealthy subjectsStudy participationPsychotic disordersPlasma prolactinSchizophrenia symptomsPatientsSchizophreniaCognitive effectsPerceptual alterationsDeficitsCannabisSubjectsAkathisiaExacerbation