Investigating the effects of propranolol and nicotine patches on smoking cues

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

This study is testing whether taking propranolol and using nicotine patches can help daily smokers resist the urge to smoke when they see things that remind them of smoking.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 21 Years to 60 Years
• Sex: All
• Sponsor: University of Oklahoma (Academic / other)
• Locations: 1 site (Tulsa, Oklahoma)
• Trial ID: NCT05587361 on ClinicalTrials.gov

What this trial studies

This study examines how a beta-adrenergic antagonist, propranolol, and a nicotine patch affect responses to smoking cues in daily smokers. Participants will receive either the medications or placebos and undergo neuroimaging to assess brain activity and behavioral responses. The goal is to understand if combining these treatments can reduce the urge to smoke when exposed to smoking-related cues. Participants will attend four sessions involving questionnaires, monitoring, and MRI scans.

Who should consider this trial

Good fit: Ideal candidates are generally healthy adults aged 21-60 who smoke at least 5 cigarettes per day and have been smoking regularly for over a year.

Not a fit: Patients with significant health issues, those who cannot undergo MRI, or individuals currently using psychoactive medications may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatments for tobacco use disorder by targeting smoking cues and cravings more effectively.

How similar studies have performed: Previous pilot studies have shown that propranolol can suppress smoking cue reactivity, indicating potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

1. Generally healthy
2. Age 21-60
3. Right-handed using a three-item scale
4. Daily smoker of ≥ 5 cigarettes/day delivering 0.5 mg nicotine (FTC)
5. Smoking regularly for ≥ 1 year, with stable smoking for the past 6 months
6. Afternoon expired Carbon Monoxide (CO) concentration ≥ 6 ppm and/or morning urinary cotinine \>100 ng/ml
7. Must identity at least 4 different smoking locations used in a typical week
8. Able to read and understand English

Exclusion Criteria:

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

Where this trial is running

Tulsa, Oklahoma

• Hardesty Center for Clinical Research and Neuroscience — Tulsa, Oklahoma, United States (Recruiting)

Study contacts

• Principal investigator: Jason A Oliver, PhD — University of Oklahoma
• Study coordinator: Jason A Oliver, PhD

Conditions Tobacco Use Disorder; Nicotine Dependence; Cigarette Smoking