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NCT Number: NCT05587361

Beta-Adrenergic Modulation of Drug Cue Reactivity

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.

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Key information

Age range

21 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hardesty Center for Clinical Research and Neuroscience

Tulsa, Oklahoma, 74136, United States

Location status: Recruiting

Location contact

Isabel Brush, B.A.

CONTACT

[email protected]

Rebecca Gonzalez, B.A.

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Generally healthy
  • Age 21-60
  • 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

Exclusion criteria

  • 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)

Treatment and study plan

Propranolol

Drug

Propranolol Capsule; 40 mg IR

Nicotine patch

Drug

Nicotine Patch; 14 mg

Placebo Propranolol

Drug

Placebo Capsule, no active ingredients

Placebo Patch

Drug

Placebo Patch, no active ingredients

Primary outcomes

  1. Cue-Provoked Craving Ratings

    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.

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

    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

  3. Association between Smoking Urge and Brain Activation

    Time frame: Approximately 4-5 hours

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

  4. Hippocampus-Amygdala connectivity to smoking cues

    Time frame: Approximately 4-5 hours

    Index of connectivity between these brain regions

  5. Medial Prefrontal Cortex and Posterior Cingulate Cortex connectivity

    Time frame: Approximately 4-5 hours

    Index of connectivity between these brain regions

  6. Association between Smoking Urge and Brain Connectivity

    Time frame: Approximately 4-5 hours

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

Study contacts

Contact information is provided by the study sponsor or research team.

Isabel Brush, B.A.

CONTACT

[email protected]

Jason A Oliver, PhD

CONTACT

[email protected]

405-271-8001 ext. 14005

Sponsors and collaborators

Lead sponsor

University of Oklahoma

Other

Collaborators

  • Duke University
  • National Institute on Drug Abuse (NIDA)
  • National Institutes of Health (NIH)
  • Oklahoma State University Center for Health Sciences

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Oct 20, 2022
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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