NCT05587361

Beta-Adrenergic Modulation of Drug Cue Reactivity

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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: University of Oklahoma · Academic / Other
• Sex: All
• Age: 21 Years – 60 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Tobacco Use Disorder
• Nicotine Dependence
• Cigarette Smoking

Interventions

Type	Name	Description
DRUG	Propranolol	Propranolol Capsule; 40 mg IR
DRUG	Nicotine Patch	Nicotine Patch; 14 mg
DRUG	Placebo Propranolol	Placebo Capsule, no active ingredients
DRUG	Placebo Patch	Placebo Patch, no active ingredients

Timeline

• Start date: 2024-11-26
• Primary completion: 2026-03-01
• Completion: 2026-03-01
• First posted: 2022-10-20
• Last updated: 2025-02-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study