2024
Psychological flexibility as a mechanism of change in psilocybin-assisted therapy for major depression: results from an exploratory placebo-controlled trial
Sloshower J, Zeifman R, Guss J, Krause R, Safi-Aghdam H, Pathania S, Pittman B, D’Souza D. Psychological flexibility as a mechanism of change in psilocybin-assisted therapy for major depression: results from an exploratory placebo-controlled trial. Scientific Reports 2024, 14: 8833. PMID: 38632313, PMCID: PMC11024097, DOI: 10.1038/s41598-024-58318-x.Peer-Reviewed Original ResearchConceptsPsilocybin-assisted therapyPsychological flexibilityDepression severityModerate to severe MDDSpectrum of neuropsychiatric conditionsTarget psychological flexibilityIncrease psychological flexibilityMental health conditionsManualized psychotherapyPsilocybin treatmentSevere MDDDepressive disorderExperiential acceptanceCommitment therapyDosing sessionsNeuropsychiatric conditionsPsychedelic trialsPlacebo-controlled trialWithin-subjectMDDPsilocybinAdministered placeboPlacebo-controlledDepressionClinical samples
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
2016
Feasibility and success of cell-phone assisted remote observation of medication adherence (CAROMA) in clinical trials
DeWorsop D, Creatura G, Bluez G, Thurnauer H, Forselius-Bielen K, Ranganathan M, Deaso E, Bhat JA, D’Souza D. Feasibility and success of cell-phone assisted remote observation of medication adherence (CAROMA) in clinical trials. Drug And Alcohol Dependence 2016, 163: 24-30. PMID: 27068252, DOI: 10.1016/j.drugalcdep.2016.02.045.Peer-Reviewed Original ResearchConceptsMedication adherenceClinical trialsStudy medicationMedication nonadherenceDrug levelsActive study medicationWeekly study visitsPlacebo-controlled trialPlasma drug levelsSubstance abuse disordersPill countStudy visitStudy completionFace visitsClinical careAbuse disordersMedicationsCannabis dependencePilot studyTrialsAdherenceVisitsNonadherenceWeekly faceHigh rate