[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05587361":3,"trial-entities:NCT05587361":111,"trial-summary:NCT05587361":114},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":22,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":52,"secondary_outcomes":70,"sex":71,"minimum_age":72,"maximum_age":73,"healthy_volunteers":74,"eligibility_criteria":75,"std_ages":79,"locations":81,"central_contacts":99,"overall_officials":106,"references":109,"see_also_links":110},"NCT05587361","2022005-OSU-CHS","Beta-Adrenergic Modulation of Drug Cue Reactivity","Beta-Adrenergic Modulation of Drug Cue Reactivity: Neural and Behavioral Mechanisms","RECRUITING","2027-03-31","2026-04","2026-04-28","2024-11-26","University of Oklahoma","OTHER",false,"This study is designed to investigate the effects of a beta-adrenergic antagonist (Propranolol; 40 mg IR) and nicotine patch (14 mg) administered alone and in combination on neurobiological and behavioral responses to smoking cues in ongoing cigarette smokers. This is a basic experimental study in humans and participants will not take these medications for an extended period or make a cessation attempt as part of their involvement in this research project.","Cigarette use remains a serious public health problem in the United States and worldwide. Effective pharmacological interventions for smoking cessation exist, but these medications primarily target nicotine withdrawal and smoking reinforcement. The cues and contexts associated with smoking also play an important role in driving smoking behavior, but evidence is extremely mixed whether existing interventions can effectively attenuate smoking urges and behavior in response to these cues and contexts.\n\nIn a previous pilot trial, the investigators demonstrated that propranolol suppressed smoking cue reactivity and brain activation across a constellation of brain regions implicated in nicotine dependence. Here, the investigators seek to extend this work by examining effects when the drug is administered in combination with an established treatment targeting withdrawal and reinforcement (i.e., nicotine patch).\n\nFollowing consent and screening\u002Fbaseline activities, participants will attend four neuroimaging appointments each lasting approximately 5 hours. Participants will be fitted with a nicotine or placebo patch, fed a standard meal and then administered propranolol or placebo. Participants will complete questionnaires and have their heart rate\u002Fblood pressure monitored throughout the visit. During the MRI scan, participants will be asked to complete both resting scans and task-based scans during which participants will view images of smoking and non-smoking objects and scenes.",[19,20,21],"Tobacco Use Disorder","Nicotine Dependence","Cigarette Smoking",[],"INTERVENTIONAL","BASIC_SCIENCE",[26],"PHASE4",{"count":28,"type":29},80,"ESTIMATED",[31,38,43,48],{"type":32,"name":33,"description":34,"armGroupLabels":35},"DRUG","Propranolol","Propranolol Capsule; 40 mg IR",[36,37],"Active Patch\u002FActive Propranolol","Placebo Patch\u002FActive Propranolol",{"type":32,"name":39,"description":40,"armGroupLabels":41},"Nicotine Patch","Nicotine Patch; 14 mg",[36,42],"Active Patch\u002FPlacebo Propranolol",{"type":32,"name":44,"description":45,"armGroupLabels":46},"Placebo Propranolol","Placebo Capsule, no active ingredients",[42,47],"Placebo Patch\u002FPlacebo Propranolol",{"type":32,"name":49,"description":50,"armGroupLabels":51},"Placebo Patch","Placebo Patch, no active ingredients",[37,47],[53,57,60,63,66,68],{"measure":54,"description":55,"timeFrame":56},"Cue-Provoked Craving Ratings","Self-reported smoking urges in response to smoking and non-smoking cues during magnetic resonance imaging (MRI) scan. Scores range from 0 to 10 with higher values indicating increased craving for cigarettes.","Approximately 4-5 hours",{"measure":58,"description":59,"timeFrame":56},"Blood-Oxygen Level Dependent (BOLD) Activation to Smoking Cues","Blood-Oxygen Level Dependent (BOLD) Contrast (Smoking-Neutral) in Anterior Hippocampus, Amygdala, Dorsal Anterior Insula, Medial Prefrontal Cortex, Posterior Cingulate Cortex and Ventral Striatum",{"measure":61,"description":62,"timeFrame":56},"Association between Smoking Urge and Brain Activation","Indices of covariation between cue-provoked craving BOLD activation to smoking cues",{"measure":64,"description":65,"timeFrame":56},"Hippocampus-Amygdala connectivity to smoking cues","Index of connectivity between these brain regions",{"measure":67,"description":65,"timeFrame":56},"Medial Prefrontal Cortex and Posterior Cingulate Cortex connectivity",{"measure":69,"description":62,"timeFrame":56},"Association between Smoking Urge and Brain Connectivity",[],"ALL","21 Years","60 Years",true,{"inclusion":76,"exclusion":77,"raw_text":78},[],[],"Inclusion Criteria:\n\n1. Generally healthy\n2. Age 21-60\n3. Right-handed using a three-item scale\n4. Daily smoker of ≥ 5 cigarettes\u002Fday delivering 0.5 mg nicotine (FTC)\n5. Smoking regularly for ≥ 1 year, with stable smoking for the past 6 months\n6. Afternoon expired Carbon Monoxide (CO) concentration ≥ 6 ppm and\u002For morning urinary cotinine \\>100 ng\u002Fml\n7. Must identity at least 4 different smoking locations used in a typical week\n8. Able to read and understand English\n\nExclusion Criteria:\n\n1. Inability to attend all required sessions\n2. Significant health problems that would preclude active participation\n3. Presence of conditions that would make MRI unsafe (e.g. pacemaker) or (e.g. weight and body shape)\n4. Current use of psychoactive medications\u002Fdrugs as indicated by self-report or urine screen\n5. Positive breath alcohol concentration\n6. Pregnant, breastfeeding, or planning to become pregnant during the course of the study (females)\n7. Problems with vision that cannot be corrected with contacts or glasses\n8. Current regular use of smokeless tobacco, smoking cessation medications, or other nicotine containing products (e.g. electronic cigarettes)\n9. Current use of beta-adrenergic medications (e.g. beta-blockers) or other blood pressure medications\n10. Systolic blood pressure \\\u003C 90 mmHg or diastolic blood pressure \\\u003C 60 mmHg (sitting or standing)\n11. Abnormal EKG\n12. Presence of severe anemia\n13. Presence of electrolyte imbalance that could impact blood pressure\n14. Presence of any other contraindications for propranolol or nicotine patch (e.g. cardiovascular disease, bronchial asthma, prior allergic reactions, diabetes)",[80],"ADULT",[82],{"facility":83,"status":8,"city":84,"state":85,"zip":86,"country":87,"contacts":88,"geoPoint":96},"Hardesty Center for Clinical Research and Neuroscience","Tulsa","Oklahoma","74136","United States",[89,93],{"name":90,"role":91,"email":92},"Isabel Brush, B.A.","CONTACT","Isabel-Brush@ouhsc.edu",{"name":94,"role":91,"email":95},"Rebecca Gonzalez, B.A.","Rebecca-Gonzalez@ouhsc.edu",{"lat":97,"lon":98},36.15398,-95.99277,[100,105],{"name":101,"role":91,"phone":102,"phoneExt":103,"email":104},"Jason A Oliver, PhD","405-271-8001","14005","Jason-Oliver@ouhsc.edu",{"name":90,"role":91,"email":92},[107],{"name":101,"affiliation":13,"role":108},"PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":112,"biomarkers":113},[21,20,19],[],{"nct_id":4,"found":74,"summary":115,"prompt_version":125},{"design":116,"status":117,"heading":118,"summary":119,"follow_up":120,"word_count":121,"commitments":122,"compensation":123,"drugs_mentioned":124},"This interventional study plans to enroll 80 participants. It will test Propranolol, a Nicotine Patch, and their placebos, both alone and in combination.","completed","Study on Propranolol and Nicotine Patch for Smoking Cues","This study is investigating how two medications, Propranolol (a beta-blocker) and a Nicotine Patch, affect your brain and behavior when you see things that make you want to smoke. Researchers want to see if these medications, alone or together, can reduce cravings and brain activity linked to smoking cues. You might be able to join if you are a generally healthy daily smoker between 21 and 60 years old. The study will measure your craving ratings and brain activity using fMRI (functional magnetic resonance imaging) about 4-5 hours after you receive the medications. This is a basic research study, and you will not be trying to quit smoking as part of your involvement. The current status of this study is unclear.","The primary measurements for this study are taken approximately 4-5 hours after medication administration during each visit.",121,"You will attend four neuroimaging appointments, each lasting about 5 hours. During these visits, you will receive a patch and medication, eat a meal, complete questionnaires, and have your heart rate and blood pressure monitored.","Not stated in the trial record.",[33,39],"v2"]