RecruitingPhase 4NCT05587361

Beta-Adrenergic Modulation of Drug Cue Reactivity

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


Sponsor

University of Oklahoma

Enrollment

80 participants

Start Date

Nov 26, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 21 YearsMax Age: 60 Years

Inclusion Criteria8

  • 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 Criteria14

  • 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)

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Interventions

DRUGPropranolol

Propranolol Capsule; 40 mg IR

DRUGNicotine Patch

Nicotine Patch; 14 mg

DRUGPlacebo Propranolol

Placebo Capsule, no active ingredients

DRUGPlacebo Patch

Placebo Patch, no active ingredients


Locations(1)

Hardesty Center for Clinical Research and Neuroscience

Tulsa, Oklahoma, United States

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NCT05587361


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