2025
A randomized, placebo-controlled, double-blind, pilot study of cannabis-related driving impairment assessed by driving simulator and self-report
Meda S, Stevens M, Boer E, Pittman B, Gueorguieva R, Huestis M, Pearlson G. A randomized, placebo-controlled, double-blind, pilot study of cannabis-related driving impairment assessed by driving simulator and self-report. Journal Of Psychopharmacology 2025, 39: 364-372. PMID: 40077985, DOI: 10.1177/02698811251324379.Peer-Reviewed Original ResearchConceptsCannabis-induced impairmentBlood THC levelsDouble-blindCannabis useVaporized cannabisTHC levelsActual impairmentAcute doseWithin-subjectSelf-ReportSimulated driving testDrug effectsDriving impairmentPlacebo-ControlledImpairment indicatorsImpairmentCannabisAssessment daysEffect of doseParticipants' willingnessPost-doseTHCBehavioral metricsCar-followingParticipants
2023
Naltrexone plus bupropion combination medication maintenance treatment for binge-eating disorder following successful acute treatments: randomized double-blind placebo-controlled trial
Grilo C, Lydecker J, Gueorguieva R. Naltrexone plus bupropion combination medication maintenance treatment for binge-eating disorder following successful acute treatments: randomized double-blind placebo-controlled trial. Psychological Medicine 2023, 53: 7775-7784. PMID: 37366017, PMCID: PMC10751383, DOI: 10.1017/s0033291723001800.Peer-Reviewed Original ResearchConceptsNaltrexone/bupropionBinge-eating disorderBinge-eating remissionAcute treatmentMaintenance treatmentBinge-eating frequencyDouble-blind placebo-controlled trialBehavioral weight loss therapyWeight lossCo-occurring obesitySuccessful acute treatmentPlacebo-controlled trialWeight loss therapySignificant additional weight lossSingle-site trialAdditional weight lossAcute efficacyRemission rateAdult patientsComorbid obesityBupropionInitial interventionPosttreatment assessmentRespondersPlaceboDoes Symptom-Onset Treatment With Sertraline Improve Functional Impairment for Individuals With Premenstrual Dysphoric Disorder?
Yonkers K, Altemus M, Gilstad-Hayden K, Kornstein S, Gueorguieva R. Does Symptom-Onset Treatment With Sertraline Improve Functional Impairment for Individuals With Premenstrual Dysphoric Disorder? Journal Of Clinical Psychopharmacology 2023, 43: 320-325. PMID: 37212651, PMCID: PMC10313784, DOI: 10.1097/jcp.0000000000001700.Peer-Reviewed Original ResearchConceptsPremenstrual dysphoric disorderFunctional impairmentSymptom onsetPMDD symptomsDysphoric disorderAnger/irritabilityDaily treatmentActive treatmentFunctional outcomeClinical trialsFunctional improvementSecondary analysisCausal mediation analysisSertralineSeverity of problemsImpairmentNonsignificant direct effectDaily ratingsPlaceboTreatmentFace validitySymptomsIrritabilityDisordersSignificant indirect effectRandomized controlled trial of the glycine transporter 1 inhibitor PF-03463275 to enhance cognitive training and neuroplasticity in schizophrenia
Surti T, Ranganathan M, Johannesen J, Gueorguieva R, Deaso E, Kenney J, Krystal J, D'Souza D. Randomized controlled trial of the glycine transporter 1 inhibitor PF-03463275 to enhance cognitive training and neuroplasticity in schizophrenia. Schizophrenia Research 2023, 256: 36-43. PMID: 37141764, PMCID: PMC10257994, DOI: 10.1016/j.schres.2023.04.010.Peer-Reviewed Original ResearchMeSH KeywordsAntipsychotic AgentsCognitive TrainingDouble-Blind MethodGlycine Plasma Membrane Transport ProteinsHumansNeuronal PlasticitySchizophreniaConceptsGlycine transporter 1Cytochrome P450 2D6 extensive metabolizersGlyT1 inhibitorsWeeks of washoutWeeks of CTMedication adherenceReceptor hypofunctionImpaired neuroplasticityPharmacodynamic variabilityNMDAR functionExtensive metabolizersTreatment periodPsychotic symptomsStable outpatientsCognitive impairmentGlyT1 occupancyTransporter 1CTNeuroplasticityCognitive training strategiesSchizophreniaComputerized CTCognitive performanceAugmentation studiesGreater improvement
2022
Naltrexone-Bupropion and Behavior Therapy, Alone and Combined, for Binge-Eating Disorder: Randomized Double-Blind Placebo-Controlled Trial
Grilo CM, Lydecker JA, Fineberg SK, Moreno JO, Ivezaj V, Gueorguieva R. Naltrexone-Bupropion and Behavior Therapy, Alone and Combined, for Binge-Eating Disorder: Randomized Double-Blind Placebo-Controlled Trial. American Journal Of Psychiatry 2022, 179: 927-937. PMID: 36285406, PMCID: PMC9722598, DOI: 10.1176/appi.ajp.20220267.Peer-Reviewed Original ResearchMeSH KeywordsBehavior TherapyBinge-Eating DisorderBupropionDouble-Blind MethodFemaleHumansMaleMiddle AgedNaltrexoneObesityTreatment OutcomeWeight LossConceptsBehavioral weight loss therapyBinge-eating disorderPlacebo groupBupropion groupWeight lossRandomized double-blind placebo-controlled trialDouble-blind placebo-controlled trialLogistic regressionBinge-eating remissionPlacebo-controlled trialWeight loss therapyDouble-blind placeboSerious public health problemPublic health problemEvidence-based treatmentsRate of participantsBinge-eating frequencyBinge Eating DisorderMedical comorbiditiesRemission rateLoss therapyPercent weight lossMixed modelsFunctional impairmentSecondary measuresDose-related effects of ketamine for antidepressant-resistant symptoms of posttraumatic stress disorder in veterans and active duty military: a double-blind, randomized, placebo-controlled multi-center clinical trial
Abdallah CG, Roache JD, Gueorguieva R, Averill LA, Young-McCaughan S, Shiroma PR, Purohit P, Brundige A, Murff W, Ahn KH, Sherif MA, Baltutis EJ, Ranganathan M, D’Souza D, Martini B, Southwick SM, Petrakis IL, Burson RR, Guthmiller KB, López-Roca AL, Lautenschlager KA, McCallin JP, Hoch MB, Timchenko A, Souza SE, Bryant CE, Mintz J, Litz BT, Williamson DE, Keane TM, Peterson AL, Krystal JH. Dose-related effects of ketamine for antidepressant-resistant symptoms of posttraumatic stress disorder in veterans and active duty military: a double-blind, randomized, placebo-controlled multi-center clinical trial. Neuropsychopharmacology 2022, 47: 1574-1581. PMID: 35046508, PMCID: PMC8767037, DOI: 10.1038/s41386-022-01266-9.Peer-Reviewed Original ResearchMeSH KeywordsAntidepressive AgentsDouble-Blind MethodHumansKetamineMilitary PersonnelStress Disorders, Post-TraumaticTreatment OutcomeVeteransConceptsPosttraumatic stress disorderClinical trialsOutcome measuresMontgomery-Åsberg Depression Rating ScaleSelf-report PTSD ChecklistÅsberg Depression Rating ScaleStress disorderPTSD symptomsAntidepressant-resistant symptomsPrevious antidepressant treatmentClinician-Administered PTSD ScaleMulti-center clinical trialRapid antidepressant effectsSecondary outcome measuresPrimary outcome measureSignificant dose-related effectsRole of ketamineDepression Rating ScaleDose-related effectsEffects of ketamineDSM-5Intravenous placeboDose ketamineTreatment discontinuationActive duty military
2021
The effect of varenicline on smoking and drinking outcomes among Black and White adults with alcohol use disorder and co-occurring cigarette smoking: A secondary analysis of two clinical trials
Haeny AM, Gueorguieva R, Montgomery L, Bold KW, Fucito LM, Wu R, Muvvala SB, Zweben A, O'Malley SS. The effect of varenicline on smoking and drinking outcomes among Black and White adults with alcohol use disorder and co-occurring cigarette smoking: A secondary analysis of two clinical trials. Addictive Behaviors 2021, 122: 106970. PMID: 34216871, PMCID: PMC9426655, DOI: 10.1016/j.addbeh.2021.106970.Peer-Reviewed Original ResearchMeSH KeywordsAdultAlcoholismCigarette SmokingDouble-Blind MethodFemaleHumansMaleSmokingSmoking CessationTreatment OutcomeVareniclineConceptsEffects of vareniclineAlcohol use disorderCigarette smokingClinical trialsUse disordersWhite adultsEfficacy of vareniclineNumber of drinksVareniclineSmokingPrimary analysisAlcohol treatmentSecondary analysisAlcohol useTrialsBlack participantsDrinking outcomesLinear mixed modelsAdultsWhite peopleWhite participantsMixed modelingCigarettesDisordersTreatmentThreshold dose for intravenous nicotine self-administration in young adult non-dependent smokers
MacLean RR, DeVito EE, Eid T, Parida S, Gueorguieva R, Sofuoglu M. Threshold dose for intravenous nicotine self-administration in young adult non-dependent smokers. Psychopharmacology 2021, 238: 2083-2090. PMID: 33796907, PMCID: PMC8715498, DOI: 10.1007/s00213-021-05833-8.Peer-Reviewed Original ResearchConceptsDose of nicotineNicotine reinforcementHigh doseSubjective effectsHuman laboratory studiesYoung adult smokersNicotine self-administration modelNon-dependent smokersOvernight nicotine abstinenceEffects modelSelf-administration modelSelf-administration procedureNicotine doseAdult smokersMethodsYoung adultsObjectivesThe current studyNicotine abstinenceNicotine addictionHigh dosesLow dosesPlaceboThreshold doseReinforcement thresholdTobacco productsDose
2020
Naltrexone + Bupropion Combination for the Treatment of Binge-eating Disorder with Obesity: A Randomized, Controlled Pilot Study
Grilo CM, Lydecker JA, Morgan PT, Gueorguieva R. Naltrexone + Bupropion Combination for the Treatment of Binge-eating Disorder with Obesity: A Randomized, Controlled Pilot Study. Clinical Therapeutics 2020, 43: 112-122.e1. PMID: 33218742, PMCID: PMC7902424, DOI: 10.1016/j.clinthera.2020.10.010.Peer-Reviewed Original ResearchConceptsBinge-eating disorderEating-disorder psychopathologyPilot RCTTreatment of BEDOutcome time pointDouble-blind treatmentPercentage of patientsControlled Pilot StudyDiscontinuation of medicationTreatment of bingeEvidence-based treatmentsBinge-eating frequencyBupropion combinationAdult patientsAdverse eventsComorbid obesitySecondary outcomesPrimary outcomeAcute effectsFunctional impairmentPlaceboLong-term effectsPatientsMost outcomesObesityRandomized Controlled Trial Testing the Effectiveness of Adaptive “SMART” Stepped-Care Treatment for Adults With Binge-Eating Disorder Comorbid With Obesity
Grilo CM, White MA, Masheb RM, Ivezaj V, Morgan PT, Gueorguieva R. Randomized Controlled Trial Testing the Effectiveness of Adaptive “SMART” Stepped-Care Treatment for Adults With Binge-Eating Disorder Comorbid With Obesity. American Psychologist 2020, 75: 204-218. PMID: 32052995, PMCID: PMC7027689, DOI: 10.1037/amp0000534.Peer-Reviewed Original ResearchMeSH KeywordsBehavior TherapyBinge-Eating DisorderDouble-Blind MethodFemaleHumansMaleMiddle AgedObesityTreatment OutcomeWeight LossConceptsStepped-care treatmentCognitive behavioral therapyWeight loss medicationsBinge-eating disorderStepped careRemission rateWeight lossBehavioral weight lossSignificant weight lossBinge-eating frequencySignificant time effectControlled TrialsTreat analysisTreatment respondersMedicationsPlaceboMixed model analysisClinical practiceNonrespondersPatientsObesityBinge eatingCareMonthsTreatment
2019
Influence of combined treatment with naltrexone and memantine on alcohol drinking behaviors: a phase II randomized crossover trial
Krishnan-Sarin S, O’Malley S, Franco N, Cavallo DA, Tetrault JM, Shi J, Gueorguieva R, Pittman B, Krystal JH. Influence of combined treatment with naltrexone and memantine on alcohol drinking behaviors: a phase II randomized crossover trial. Neuropsychopharmacology 2019, 45: 319-326. PMID: 31590179, PMCID: PMC6901445, DOI: 10.1038/s41386-019-0536-z.Peer-Reviewed Original ResearchConceptsAlcohol drinking behaviorFirst treatment periodTreatment periodNumber of drinksCrossover trialDrinking behaviorEfficacy of naltrexoneOpioid antagonist naltrexoneNMDA antagonist memantinePositive family historyDay treatment periodSelf-administration periodAlcohol-induced stimulationAd lib accessMemantine treatmentAntagonist naltrexoneOpioid systemFamily historyNTXPriming drinkMemantineNaltrexoneAlcohol cravingHeavy drinkersAlcohol dependenceMaintenance of antidepressant and antisuicidal effects by D-cycloserine among patients with treatment-resistant depression who responded to low-dose ketamine infusion: a double-blind randomized placebo–control study
Chen MH, Cheng CM, Gueorguieva R, Lin WC, Li CT, Hong CJ, Tu PC, Bai YM, Tsai SJ, Krystal JH, Su TP. Maintenance of antidepressant and antisuicidal effects by D-cycloserine among patients with treatment-resistant depression who responded to low-dose ketamine infusion: a double-blind randomized placebo–control study. Neuropsychopharmacology 2019, 44: 2112-2118. PMID: 31421635, PMCID: PMC6898334, DOI: 10.1038/s41386-019-0480-y.Peer-Reviewed Original ResearchConceptsTreatment-resistant depressionAntisuicidal effectsPlacebo groupKetamine infusionDCS groupD-cycloserineDouble-blind randomized placebo-controlled studyN-methyl-D-aspartate (NMDA) glutamate receptorsHamilton Depression Rating Scale scoresLow-dose ketamine infusionRandomized placebo-controlled studyDepression Rating Scale scoresHAMD item 3Single subanesthetic doseInitial clinical responsePlacebo-controlled studyRating Scale scoresClinical responseDose titrationSubanesthetic doseAugmentation treatmentGlutamate receptorsMixed model analysisSuicidal riskScale scoreRepeated ketamine infusions for antidepressant-resistant PTSD: Methods of a multicenter, randomized, placebo-controlled clinical trial
Abdallah CG, Roache JD, Averill LA, Young-McCaughan S, Martini B, Gueorguieva R, Amoroso T, Southwick SM, Guthmiller K, López-Roca AL, Lautenschlager K, Mintz J, Litz BT, Williamson DE, Keane TM, Peterson AL, Krystal JH, PTSD F. Repeated ketamine infusions for antidepressant-resistant PTSD: Methods of a multicenter, randomized, placebo-controlled clinical trial. Contemporary Clinical Trials 2019, 81: 11-18. PMID: 30999057, DOI: 10.1016/j.cct.2019.04.009.Peer-Reviewed Original ResearchConceptsPosttraumatic stress disorderStudy drugClinical trialsTherapeutic effectPharmacotherapy of PTSDFirst placebo-controlled trialPlacebo-controlled clinical trialActive duty military populationDose-related efficacyMedication treatment optionsPlacebo-controlled trialDose-related effectsNovel neural mechanismActive duty militaryKetamine infusionSerotonergic antidepressantsEligible participantsTreatment optionsCase reportNew drug developmentOnly trialSustained reductionVeteran populationDrug AdministrationPilot evidenceTargeting neuroinflammation with minocycline in heavy drinkers
Petrakis IL, Ralevski E, Gueorguieva R, Sloan ME, Devine L, Yoon G, Arias AJ, Sofuoglu M. Targeting neuroinflammation with minocycline in heavy drinkers. Psychopharmacology 2019, 236: 3013-3021. PMID: 30919006, PMCID: PMC6764907, DOI: 10.1007/s00213-019-05205-3.Peer-Reviewed Original ResearchConceptsPro-inflammatory cytokine releaseEthanol-induced inflammationMicroglial activationCytokine levelsCytokine releaseHeavy drinkersSecond-generation tetracycline antibioticDose of minocyclinePlacebo-controlled trialSerum cytokine levelsSubjective responsesBaseline cytokine levelsEffects of minocyclineViable treatment strategyShort-term treatmentAlcohol use disorderNeuroimmune modulationMinocycline treatmentNeuroimmune signalingMinocycline effectsIntravenous ethanolEthanol intakeSedative responseTreatment strategiesPreclinical studiesLongitudinal Findings from a Randomized Clinical Trial of Varenicline for Alcohol Use Disorder with Comorbid Cigarette Smoking
Bold KW, Zweben A, Fucito LM, Piepmeier ME, Muvvala S, Wu R, Gueorguieva R, O'Malley SS. Longitudinal Findings from a Randomized Clinical Trial of Varenicline for Alcohol Use Disorder with Comorbid Cigarette Smoking. Alcohol Clinical And Experimental Research 2019, 43: 937-944. PMID: 30817018, PMCID: PMC7039307, DOI: 10.1111/acer.13994.Peer-Reviewed Original ResearchConceptsEnd of treatmentAlcohol use disorderHeavy drinking daysMedical managementCigarette smokingComorbid cigarette smokingUse disordersDrinking daysCo-occurring alcohol use disorderHigh ratePlacebo-controlled trialBetter clinical outcomesAssessment of alcoholPercent of participantsVarenicline treatmentClinical outcomesSmoking abstinenceParallel groupClinical trialsTimeline FollowVareniclineSmoking behaviorAlcohol treatmentPosttreatment outcomesMultisite trialAlcohol Abstainer Status and Prazosin Treatment in Association with Changes in Posttraumatic Stress Disorder Symptoms in Veterans with Comorbid Alcohol Use Disorder and Posttraumatic Stress Disorder
Verplaetse TL, Ralevski E, Roberts W, Gueorguieva R, McKee SA, Petrakis IL. Alcohol Abstainer Status and Prazosin Treatment in Association with Changes in Posttraumatic Stress Disorder Symptoms in Veterans with Comorbid Alcohol Use Disorder and Posttraumatic Stress Disorder. Alcohol Clinical And Experimental Research 2019, 43: 741-746. PMID: 30698839, PMCID: PMC6443463, DOI: 10.1111/acer.13969.Peer-Reviewed Original ResearchConceptsAlcohol use disorderPosttraumatic stress disorderPlacebo-treated individualsTotal CAPS scoresClinical trialsCAPS scoresPrazosin treatmentComorbid populationPTSD symptomsUse disordersClinician-Administered PTSD Scale scoresDouble-blind clinical trialStress disorderComorbid alcohol use disorderPrazosin-treated groupSymptoms of PTSDRecent clinical trialsComorbid alcohol dependenceCourse of treatmentΑ1-adrenergic antagonistPosttraumatic stress disorder (PTSD) symptomsOngoing symptomsSleep disturbancesMedication effectsNoradrenergic system
2018
Acute effects of inhaled menthol on the rewarding effects of intravenous nicotine in smokers
Valentine GW, DeVito EE, Jatlow PI, Gueorguieva R, Sofuoglu M. Acute effects of inhaled menthol on the rewarding effects of intravenous nicotine in smokers. Journal Of Psychopharmacology 2018, 32: 986-994. PMID: 29788802, PMCID: PMC6329876, DOI: 10.1177/0269881118773972.Peer-Reviewed Original ResearchConceptsPositive subjective effectsPositive subjective responsesIntravenous nicotineNicotine metabolismSubjective effectsNicotine metabolite ratioYoung adult smokersSlower nicotine metabolismTest sessionsSubjective responsesSevere nicotine withdrawalMenthol inhalationNicotine withdrawalAcute effectsAdult smokersWithdrawal severityNicotine infusionRewarding effectsSmokersSmoking urgesChronic exposureMetabolite ratiosAversive effectsMenthol conditionsElectronic cigarettesEffect of Varenicline Combined With Medical Management on Alcohol Use Disorder With Comorbid Cigarette Smoking: A Randomized Clinical Trial
O’Malley S, Zweben A, Fucito LM, Wu R, Piepmeier ME, Ockert DM, Bold KW, Petrakis I, Muvvala S, Jatlow P, Gueorguieva R. Effect of Varenicline Combined With Medical Management on Alcohol Use Disorder With Comorbid Cigarette Smoking: A Randomized Clinical Trial. JAMA Psychiatry 2018, 75: 129-138. PMID: 29261824, PMCID: PMC5838706, DOI: 10.1001/jamapsychiatry.2017.3544.Peer-Reviewed Original ResearchConceptsAlcohol use disorderMedical managementUse disordersCigarette smokingWeek 9Varenicline tartrateEfficacy of vareniclinePlacebo-controlled trialBehavioral health risksComorbid cigarette smokingRace/ethnicityAlcohol dependence criteriaSmoking 2Medication adherenceOutpatient clinicPlacebo pillsMean ageEligible participantsSmoking abstinenceClinical trialsParallel groupPlaceboMAIN OUTCOMEVareniclineWeek 13Dose-Related Target Occupancy and Effects on Circuitry, Behavior, and Neuroplasticity of the Glycine Transporter-1 Inhibitor PF-03463275 in Healthy and Schizophrenia Subjects
D’Souza D, Carson RE, Driesen N, Johannesen J, Ranganathan M, Krystal JH, Ahn K, Bielen K, Carbuto M, Deaso E, D’Souza D, Ranganathan M, Naganawa M, Ranganathan M, D’Souza D, Nabulsi N, Zheng M, Lin S, Huang Y, Carson R, Driesen N, Ahn K, Morgan P, Suckow R, He G, McCarthy G, Krystal J, Johannesen J, Kenney J, Gelernter J, Gueorguieva R, Pittman B. Dose-Related Target Occupancy and Effects on Circuitry, Behavior, and Neuroplasticity of the Glycine Transporter-1 Inhibitor PF-03463275 in Healthy and Schizophrenia Subjects. Biological Psychiatry 2018, 84: 413-421. PMID: 29499855, PMCID: PMC6068006, DOI: 10.1016/j.biopsych.2017.12.019.Peer-Reviewed Original ResearchMeSH KeywordsAdultAzabicyclo CompoundsBrainCognitive DysfunctionDose-Response Relationship, DrugDouble-Blind MethodFemaleGlycine Plasma Membrane Transport ProteinsHumansImidazolesKetamineLong-Term PotentiationMagnetic Resonance ImagingMaleMemory, Short-TermMiddle AgedPositron-Emission TomographySchizophreniaYoung AdultConceptsHealthy control subjectsLong-term potentiationSchizophrenia patientsControl subjectsCognitive impairmentClinical trialsGlyT1 occupancyN-methyl-D-aspartate receptor functionGlycine transporter-1 inhibitorKetamine-induced disruptionKetamine-induced effectsFunctional magnetic resonance imagingMagnetic resonance imagingPositron emission tomographyMemory-related activationF-MKSubstudy 1Schizophrenia subjectsResonance imagingReceptor functionCortical regionsEmission tomographyTarget engagementPotentiationSchizophrenia
2017
Mecamylamine treatment for alcohol dependence: a randomized controlled trial
Petrakis IL, Ralevski E, Gueorguieva R, O'Malley SS, Arias A, Sevarino KA, Jane JS, O'Brien E, Krystal JH. Mecamylamine treatment for alcohol dependence: a randomized controlled trial. Addiction 2017, 113: 6-14. PMID: 28710873, PMCID: PMC5725262, DOI: 10.1111/add.13943.Peer-Reviewed Original ResearchConceptsHeavy drinking daysDrinking daysAlcohol use disorderUse disordersAlcohol consumptionAlcohol dependenceDouble-blind clinical trialNicotinic acetylcholine receptor antagonistWeeks of treatmentAcetylcholine receptor antagonistCurrent alcohol dependenceSignificant differencesTreatment-seeking smokersMecamylamine treatmentPlacebo groupMonth 3Primary outcomeSmoking statusNicotine withdrawalReceptor antagonistNovel pharmacotherapiesClinical trialsManagement therapyMecamylamineTreatment groups
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