Recruiting

Propranolol & Nicotine Patch

Sponsor:

University of Oklahoma

Code:

NCT05587361

Conditions

Tobacco Use Disorder

Nicotine Dependence

Cigarette Smoking

Eligibility Criteria

Sex: All

Age: 21 - 60

Healthy Volunteers: Accepted

Interventions

Propranolol

Nicotine Patch

Placebo Propranolol

Placebo Patch

Study Details

Brief 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.

Conditions

Tobacco Use Disorder

Nicotine Dependence

Cigarette Smoking

Study ID

NCT05587361

Start date

Nov 26, 2024

Status verified date

Apr, 2026

Completion date

Mar 31, 2027

Anticipated

Primary completion date

Mar 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 60

Healthy Volunteers: Accepted

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)

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

placebo comparator: Placebo Patch/Placebo Propranolol

Placebo Nicotine Patch Placebo Propranolol

experimental: Placebo Patch/Active Propranolol

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

experimental: Active Patch/Placebo Propranolol

Active Nicotine Patch (14 mg) Placebo Propranolol

experimental: Active Patch/Active Propranolol

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

Interventions

Propranolol

Propranolol Capsule; 40 mg IR

Nicotine Patch

Nicotine Patch; 14 mg

Placebo Propranolol

Placebo Capsule, no active ingredients

Placebo Patch

Placebo Patch, no active ingredients

Primary outcome measure

  • Cue-Provoked Craving Ratings [ Time Frame: Approximately 4-5 hours ]
  • Blood-Oxygen Level Dependent (BOLD) Activation to Smoking Cues [ Time Frame: Approximately 4-5 hours ]
  • Association between Smoking Urge and Brain Activation [ Time Frame: Approximately 4-5 hours ]
  • Hippocampus-Amygdala connectivity to smoking cues [ Time Frame: Approximately 4-5 hours ]
  • Medial Prefrontal Cortex and Posterior Cingulate Cortex connectivity [ Time Frame: Approximately 4-5 hours ]
  • Association between Smoking Urge and Brain Connectivity [ Time Frame: Approximately 4-5 hours ]

Central Contacts and Locations

Central contacts

Locations

Hardesty Center for Clinical Research and Neuroscience

Recruiting

Tulsa, Oklahoma, United States, 74136

Contacts

Isabel Brush, B.A.

Isabel-Brush@ouhsc.edu

Rebecca Gonzalez, B.A.

Rebecca-Gonzalez@ouhsc.edu

More Information

Sponsor

University of Oklahoma

Last update posted

Apr 28, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Oklahoma on 2026-04-28.