Hardesty Center for Clinical Research and Neuroscience
Tulsa, Oklahoma, 74136, United States
Location status: Recruiting
NCT Number: NCT05587361
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.
Interested in participating?
Request Info21 year–60 year
All sexes
Interventional
Phase 4
Tulsa, Oklahoma, 74136, United States
Location status: Recruiting
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.
In 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).
Following consent and screening/baseline 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/blood 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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Propranolol Capsule; 40 mg IR
Nicotine Patch; 14 mg
Placebo Capsule, no active ingredients
Placebo Patch, no active ingredients
Time frame: Approximately 4-5 hours
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.
Time frame: Approximately 4-5 hours
Blood-Oxygen Level Dependent (BOLD) Contrast (Smoking-Neutral) in Anterior Hippocampus, Amygdala, Dorsal Anterior Insula, Medial Prefrontal Cortex, Posterior Cingulate Cortex and Ventral Striatum
Time frame: Approximately 4-5 hours
Indices of covariation between cue-provoked craving BOLD activation to smoking cues
Time frame: Approximately 4-5 hours
Index of connectivity between these brain regions
Time frame: Approximately 4-5 hours
Index of connectivity between these brain regions
Time frame: Approximately 4-5 hours
Indices of covariation between cue-provoked craving BOLD activation to smoking cues
Contact information is provided by the study sponsor or research team.
University of Oklahoma
Other
Beta-Adrenergic Modulation of Drug Cue Reactivity: Neural and Behavioral Mechanisms
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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