跳至主要内容
临床试验/NCT05587361
NCT05587361招募中4 期

Beta-Adrenergic Modulation of Drug Cue Reactivity: Neural and Behavioral Mechanisms

University of Oklahoma2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年11月26日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
招募中
入组人数
80
试验地点
2
主要终点
Blood-Oxygen Level Dependent (BOLD) Activation to Smoking Cues

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
21 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Generally healthy
  • Right-handed using a three-item scale
  • Daily smoker of ≥ 5 cigarettes/day delivering 0.5 mg nicotine (FTC)
  • Smoking regularly for ≥ 1 year, with stable smoking for the past 6 months
  • Afternoon expired Carbon Monoxide (CO) concentration ≥ 6 ppm and/or morning urinary cotinine >100 ng/ml
  • Must identity at least 4 different smoking locations used in a typical week
  • Able to read and understand English

排除标准

  • Inability to attend all required sessions
  • Significant health problems that would preclude active participation
  • Presence of conditions that would make MRI unsafe (e.g. pacemaker) or (e.g. weight and body shape)
  • Current use of psychoactive medications/drugs as indicated by self-report or urine screen
  • Positive breath alcohol concentration
  • Pregnant, breastfeeding, or planning to become pregnant during the course of the study (females)
  • Problems with vision that cannot be corrected with contacts or glasses
  • Current regular use of smokeless tobacco, smoking cessation medications, or other nicotine containing products (e.g. electronic cigarettes)
  • Current use of beta-adrenergic medications (e.g. beta-blockers) or other blood pressure medications
  • Systolic blood pressure < 90 mmHg or diastolic blood pressure < 60 mmHg (sitting or standing)
  • Abnormal EKG
  • Presence of severe anemia
  • Presence of electrolyte imbalance that could impact blood pressure
  • Presence of any other contraindications for propranolol or nicotine patch (e.g. cardiovascular disease, bronchial asthma, prior allergic reactions, diabetes)

研究组 & 干预措施

Placebo Patch/Active Propranolol

Experimental

Placebo Nicotine Patch Active Propranolol (40 mg, immediate release)

干预措施: Propranolol (Drug)

Active Patch/Active Propranolol

Experimental

Active Nicotine Patch (14 mg) Active Propranolol (40 mg, immediate release)

干预措施: Propranolol (Drug)

Active Patch/Active Propranolol

Experimental

Active Nicotine Patch (14 mg) Active Propranolol (40 mg, immediate release)

干预措施: Nicotine Patch (Drug)

Placebo Patch/Placebo Propranolol

Placebo Comparator

Placebo Nicotine Patch Placebo Propranolol

干预措施: Placebo Propranolol (Drug)

Placebo Patch/Placebo Propranolol

Placebo Comparator

Placebo Nicotine Patch Placebo Propranolol

干预措施: Placebo Patch (Drug)

Placebo Patch/Active Propranolol

Experimental

Placebo Nicotine Patch Active Propranolol (40 mg, immediate release)

干预措施: Placebo Patch (Drug)

Active Patch/Placebo Propranolol

Experimental

Active Nicotine Patch (14 mg) Placebo Propranolol

干预措施: Nicotine Patch (Drug)

Active Patch/Placebo Propranolol

Experimental

Active Nicotine Patch (14 mg) Placebo Propranolol

干预措施: Placebo Propranolol (Drug)

结局指标

主要结局

Blood-Oxygen Level Dependent (BOLD) Activation to Smoking Cues

时间窗: 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

Association between Smoking Urge and Brain Activation

时间窗: Approximately 4-5 hours

Indices of covariation between cue-provoked craving BOLD activation to smoking cues

Cue-Provoked Craving Ratings

时间窗: 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.

Hippocampus-Amygdala connectivity to smoking cues

时间窗: Approximately 4-5 hours

Index of connectivity between these brain regions

Medial Prefrontal Cortex and Posterior Cingulate Cortex connectivity

时间窗: Approximately 4-5 hours

Index of connectivity between these brain regions

Association between Smoking Urge and Brain Connectivity

时间窗: Approximately 4-5 hours

Indices of covariation between cue-provoked craving BOLD activation to smoking cues

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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