80 Participants Needed

Propranolol + Nicotine Patch for Smoking Addiction

JA
TA
IB
Overseen ByIsabel Brush, B.A.
Prior Safety DataThis treatment has passed at least one previous human trial

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?

The study on labetalol, a similar type of drug to propranolol, showed that it could help reduce withdrawal symptoms when combined with nicotine replacement therapy. This suggests that propranolol might also help when used with nicotine patches, although more research is needed to confirm this.12345

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

JA

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

Able to read and understand English
Must identify at least 4 different smoking locations used in a typical week
I smoke 5 or more cigarettes daily.
See 5 more

Exclusion Criteria

Problems with vision that cannot be corrected with contacts or glasses
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)
See 11 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline

Participants undergo baseline assessments including consent and initial measurements

1 week

Neuroimaging Sessions

Participants attend four neuroimaging appointments, each lasting approximately 5 hours, to assess neural and behavioral responses to smoking cues

4 weeks
4 visits (in-person)

Follow-up

Participants are monitored for any delayed effects or safety concerns after the neuroimaging sessions

2 weeks

Treatment Details

Interventions

  • Nicotine Patch
  • Placebo Patch
  • Placebo Propranolol
  • Propranolol
Trial OverviewThe study tests the effects of Propranolol (a beta-blocker) and nicotine patches on smokers' reactions to cues that make them want to smoke. It's not a long-term treatment test but looks at immediate responses in controlled settings. Participants will receive either the actual drugs or placebos in various combinations.
Participant Groups
4Treatment groups
Experimental Treatment
Placebo Group
Group I: Placebo Patch/Active PropranololExperimental Treatment2 Interventions
Placebo Nicotine Patch Active Propranolol (40 mg, immediate release)
Group II: Active Patch/Placebo PropranololExperimental Treatment2 Interventions
Active Nicotine Patch (14 mg) Placebo Propranolol
Group III: Active Patch/Active PropranololExperimental Treatment2 Interventions
Active Nicotine Patch (14 mg) Active Propranolol (40 mg, immediate release)
Group IV: Placebo Patch/Placebo PropranololPlacebo Group2 Interventions
Placebo Nicotine Patch Placebo Propranolol

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Oklahoma

Lead Sponsor

Trials
484
Recruited
95,900+

Oklahoma State University Center for Health Sciences

Collaborator

Trials
37
Recruited
4,900+

Duke University

Collaborator

Trials
2,495
Recruited
5,912,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials
2,658
Recruited
3,409,000+

National Institutes of Health (NIH)

Collaborator

Trials
2,896
Recruited
8,053,000+

Findings from Research

In a double-blind clinical trial with 73 participants, propranolol showed no significant effect on helping smokers quit, as only six individuals stopped smoking after eight weeks, equally split between the propranolol and placebo groups.
The results indicate that propranolol is not an effective intervention for smoking cessation, highlighting the need for alternative strategies to support individuals trying to quit smoking.
Propranolol and giving up smoking.Farebrother, MJ., Pearce, SJ., Turner, P., et al.[2013]
Cigarette smoking is the leading cause of preventable death in the U.S., with over 3,000 children starting to smoke daily, highlighting the urgent need for effective smoking cessation strategies.
Pharmacological interventions, such as Zyban and various nicotine replacement therapies (like patches and gum), can help alleviate withdrawal symptoms and support individuals in quitting smoking.
Using nicotine replacement therapy in treating nicotine addiction in adolescents.Maharaj, K., Ternullo, S.[2018]
In a study involving 9 smokers, labetalol, an adrenergic receptor blocker, significantly reduced the heart rate increase caused by nicotine, indicating its potential to mitigate some acute physiological effects of nicotine.
High-dose labetalol treatment also notably reduced tobacco withdrawal symptoms after nicotine administration, suggesting that adrenergic receptors play a role in these symptoms and highlighting the need for further research on using adrenergic blockers in smoking cessation therapies.
Labetalol treatment enhances the attenuation of tobacco withdrawal symptoms by nicotine in abstinent smokers.Sofuoglu, M., Babb, D., Hatsukami, DK.[2015]

References

Propranolol and giving up smoking. [2013]
Using nicotine replacement therapy in treating nicotine addiction in adolescents. [2018]
Labetalol treatment enhances the attenuation of tobacco withdrawal symptoms by nicotine in abstinent smokers. [2015]
New trends in the treatment of nicotine addiction. [2016]
The efficacy of computer-tailored smoking cessation material as a supplement to nicotine patch therapy. [2019]
Central beta 1-adrenergic receptors are involved in CRF-induced defensive withdrawal. [2019]
Neural substrates of propranolol-induced impairments in the reconsolidation of nicotine-associated memories in smokers. [2023]
Comparison of the pharmacokinetics of two nicotine transdermal systems: nicoderm and habitrol. [2019]
Adrenergic blocker carvedilol attenuates the cardiovascular and aversive effects of nicotine in abstinent smokers. [2018]
10.United Statespubmed.ncbi.nlm.nih.gov
Long-acting propranolol (Inderal LA): pharmacokinetics, pharmacodynamics and therapeutic use. [2019]
Pharmacokinetic and pharmacodynamic studies with a new controlled-release formulation of propranolol in normal volunteers: a comparison with other commercially available formulations. [2019]
The relationship between smoking and the response to anti-hypertensive treatment in mild hypertensives in the Medical Research Council's trial of treatment. [2019]
13.United Statespubmed.ncbi.nlm.nih.gov
Evaluation of propranolol in opiate dependence. [2019]