Propranolol + Nicotine Patch for Smoking Addiction
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
Yes, you will need to stop taking any psychoactive medications, smokeless tobacco, smoking cessation medications, nicotine products, beta-adrenergic medications, or other blood pressure medications to participate in this trial.
What data supports the effectiveness of the treatment Propranolol + Nicotine Patch for smoking addiction?
Is the combination of propranolol and nicotine patch safe for humans?
Propranolol has been studied for its effects on memory and craving in smokers, showing it can decrease craving without significant safety concerns. Nicotine patches, like Nicoderm, have been used safely to help people quit smoking, although they can cause side effects like skin irritation. Overall, both treatments have been used safely in humans, but combining them specifically for smoking addiction needs more research to confirm safety.36789
How does the drug propranolol combined with a nicotine patch differ from other smoking addiction treatments?
The combination of propranolol, a beta-blocker typically used for heart conditions, with a nicotine patch is unique because it attempts to address both the physical addiction to nicotine and the stress or anxiety associated with quitting smoking. However, previous studies have shown that propranolol alone does not significantly help people stop smoking, making this combination a novel approach.110111213
Research Team
Jason A Oliver, PhD
Principal Investigator
University of Oklahoma
Eligibility Criteria
This trial is for English-speaking, right-handed adults aged 21-60 who have been smoking regularly for at least a year. Participants should smoke over 5 cigarettes daily and be generally healthy. Exclusions include low blood pressure, use of psychoactive drugs or certain medications, pregnancy, abnormal EKG results, severe anemia or electrolyte issues, MRI safety risks like pacemakers, vision problems uncorrectable with glasses/contacts, and significant health conditions.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Baseline
Participants undergo baseline assessments including consent and initial measurements
Neuroimaging Sessions
Participants attend four neuroimaging appointments, each lasting approximately 5 hours, to assess neural and behavioral responses to smoking cues
Follow-up
Participants are monitored for any delayed effects or safety concerns after the neuroimaging sessions
Treatment Details
Interventions
- Nicotine Patch
- Placebo Patch
- Placebo Propranolol
- Propranolol
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Oklahoma
Lead Sponsor
Oklahoma State University Center for Health Sciences
Collaborator
Duke University
Collaborator
National Institute on Drug Abuse (NIDA)
Collaborator
National Institutes of Health (NIH)
Collaborator