Nctid:
NCT06617312
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000014029", "term"=>"Tobacco Use Disorder"}], "ancestors"=>[{"id"=>"D000019966", "term"=>"Substance-Related Disorders"}, {"id"=>"D000064419", "term"=>"Chemically-Induced Disorders"}, {"id"=>"D000001523", "term"=>"Mental Disorders"}], "browseLeaves"=>[{"id"=>"M16785", "name"=>"Tobacco Use Disorder", "asFound"=>"Tobacco Use Disorder", "relevance"=>"HIGH"}, {"id"=>"M21837", "name"=>"Substance-Related Disorders", "relevance"=>"LOW"}, {"id"=>"M30302", "name"=>"Chemically-Induced Disorders", "relevance"=>"LOW"}, {"id"=>"M4815", "name"=>"Mental Disorders", "relevance"=>"LOW"}, {"id"=>"M14473", "name"=>"Psychotic Disorders", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Substance Related Disorders", "abbrev"=>"BC25"}, {"name"=>"Behaviors and Mental Disorders", "abbrev"=>"BXM"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}, "interventionBrowseModule"=>{"browseLeaves"=>[{"id"=>"M3473", "name"=>"Acetylcholine", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Vasodilator Agents", "abbrev"=>"VaDiAg"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE2"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"TRIPLE", "whoMasked"=>["PARTICIPANT", "CARE_PROVIDER", "INVESTIGATOR"]}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"PARALLEL", "interventionModelDescription"=>"We will randomize 64 non-treatment seeking adults who smoke cigarettes (N=32 cytisinicline, N=32 placebo; 50% females) in a double-blind, placebo-controlled laboratory study testing the effects of cytisinicline on the neural substrates of cigarette cue reactivity. All participants will be daily combustible cigarette smokers. Interested individuals will call the lab and complete a telephone screening interview. Individuals who are deemed eligible will receive a full explanation of study procedures and provide written, informed consent. Participants will then complete a behavioral screen and physical exam. Eligible participants will then be randomized to a medication, cytisinicline (3 mg, 3 times daily) or placebo (0mg, 3 times daily). Participants will complete brief daily diary self-reports of cigarette use and craving during the outpatient medication period. Following 2- to 3-weeks of cytisinicline, or placebo, treatment participants will complete a cigarette cue-exposure fMRI task."}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>64}}, "statusModule"=>{"overallStatus"=>"NOT_YET_RECRUITING", "startDateStruct"=>{"date"=>"2025-01", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2026-12", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-09-24", "studyFirstSubmitDate"=>"2024-09-24", "studyFirstSubmitQcDate"=>"2024-09-24", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-27", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-27", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2026-12", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Blood-oxygen-level-dependent (BOLD) activation to cigarette cues during fMRI task", "timeFrame"=>"From enrollment to end of treatment at 2-to-3 weeks", "description"=>"Participants will complete a cigarette cue-exposure task during fMRI. In this paradigm, participants are exposed to videotaped cues of smoking and control, non-cigarette related, content. Blood-oxygen-level-dependent (BOLD) activation to cigarette (vs. non-cigarette control ) cues will be calculated."}], "secondaryOutcomes"=>[{"measure"=>"In-scanner cigarette cue-induced subjective craving", "timeFrame"=>"From enrollment to end of treatment at 2-to-3 weeks", "description"=>"In-scanner cigarette cue-induced subjective craving ratings will be obtained following each cue exposure during the fMRI task."}, {"measure"=>"Subjective cigarette craving during outpatient period", "timeFrame"=>"From enrollment to end of treatment at 2-to-3 weeks", "description"=>"Subjective cigarette craving, as assessed via daily diary self-report assessments, during the outpatient medication period"}]}, "oversightModule"=>{"isUsExport"=>false, "oversightHasDmc"=>false, "isFdaRegulatedDrug"=>true, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["smoking cesstion", "tobacco use disorder", "cigarette smoking", "fMRI", "cytisinicline"], "conditions"=>["Smoking Cessation", "Tobacco Use Disorder"]}, "descriptionModule"=>{"briefSummary"=>"This study will randomize 64 non-treatment seeking individuals who smoke cigarettes daily in a double-blind, placebo-controlled laboratory study testing the effects of cytisinicline on the neural substrates of cigarette cue reactivity.", "detailedDescription"=>"The objective of this study is to examine the effects of cytisinicline on neural substrates of cigarette cue-reactivity. We will randomize 64 adults who smoke cigarettes daily (N=32 cytisinicline, N=32 placebo; 50% female) into a double-blind, placebo-controlled laboratory study of cytisinicline. Specifically, participants will complete a 2- to 3-week outpatient protocol that includes taking cytisinicline (3 mg, 3 times daily) or matched placebo (0 mg, 3 times daily) and completing a brief daily diary assessment of cigarette use and craving. Following 2- to 3-weeks of cytisinicline (or placebo) treatment, participants will complete a cigarette cue-exposure task during fMRI. Total study participation will be approximately 4 weeks."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"65 years", "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n1. be between the ages of 18 and 65 and provide informed consent;\n2. smoke 10 or more combustible cigarettes per day;\n3. not seeking treatment for smoking;\n\nExclusion Criteria:\n\n1. current use of other smoking cessation aid (bupropion, varenicline, nortriptyline, NRT);\n2. more than 3 months of smoking abstinence in past year;\n3. use of non-cigarette tobacco product (pipe tobacco, cigars, smokeless tobacco, hookah) or electronic cigarettes in 28-days prior to enrollment;\n4. current use of psychoactive drug (excluding cannabis), as determined by urine toxicology;\n5. current (past 12-month) DSM-5 diagnosis of substance use disorder for any substances other than tobacco and mild cannabis or alcohol use disorders;\n6. lifetime history of psychotic disorders, bipolar disorders, or major depression with suicidal ideation;\n7. serious medical illness within past 6 months;\n8. have a medical condition that may interfere with safe study participation.\n9. renal impairment defined as a creatinine clearance (CrCl) greater than 60 mL/min (estimated with the Cockroft-Gault equation).\n10. non-removable ferromagnetic object in body;\n11. claustrophobia;\n12. serious head injury or period of unconsciousness (more than 30 minutes);\n13. more than 250lbs;\n14. pregnancy, nursing, or refusal to use reliable birth control if female;\n15. have experienced adverse effects to varenicline."}, "identificationModule"=>{"nctId"=>"NCT06617312", "acronym"=>"Cytisinicline", "briefTitle"=>"Examining the Effects of Cytisinicline on Neural Substrates of Cigarette Cue-reactivity", "organization"=>{"class"=>"OTHER", "fullName"=>"University of California, Los Angeles"}, "officialTitle"=>"Examining the Effects of Cytisinicline on Neural Substrates of Cigarette Cue-Reactivity", "orgStudyIdInfo"=>{"id"=>"24-001071"}, "secondaryIdInfos"=>[{"id"=>"T34FT8089", "type"=>"OTHER", "domain"=>"Tobacco Related Disease Research Program"}]}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Cytisinicline", "description"=>"3mg cytisinicline oral capsule 3 times daily for 2-to-3 weeks", "interventionNames"=>["Drug: Cytisinicline"]}, {"type"=>"PLACEBO_COMPARATOR", "label"=>"Placebo", "description"=>"matched to experimental drug", "interventionNames"=>["Drug: Placebo Oral Capsule"]}], "interventions"=>[{"name"=>"Cytisinicline", "type"=>"DRUG", "description"=>"Targets α4β2 nicotinic acetylcholine receptors", "armGroupLabels"=>["Cytisinicline"]}, {"name"=>"Placebo Oral Capsule", "type"=>"DRUG", "description"=>"Matched to active drug, cytisinicline", "armGroupLabels"=>["Placebo"]}]}, "contactsLocationsModule"=>{"centralContacts"=>[{"name"=>"Dylan E Kirsch, PhD", "role"=>"CONTACT", "email"=>"dylankirsch@psych.ucla.edu", "phone"=>"(310) 206-6756"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"University of California, Los Angeles", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Professor", "investigatorFullName"=>"Lara Ray, PhD", "investigatorAffiliation"=>"University of California, Los Angeles"}}}}
