E-cigarettes were introduced in the early 2000s as a way for smokers to manage their nicotine addiction without exposing themselves to the well-documented harms associated with the toxins and carcinogens in combustible cigarette smoke. These harms include increased risks of cancer, cardiovascular disease, chronic lung disease, and a number of other debilitating or life-threatening diseases. While many people have used e-cigarettes to quit smoking, other non-smokers have taken up e-cigarette use, particularly young adults.
However, the use of e-cigarettes, commonly known as vaping, is not without harm. Based on a review of the published data available at the time, an expert committee of the National Academies of Sciences, Engineering, and Medicine issued a finding conclusive evidence that although substituting e-cigarettes for combustible cigarettes reduced exposure to numerous toxins and carcinogens, e-cigarette use is not risk-free.
What are some of the harms? People who vape continue to be exposed to nicotine, which is highly addictive, making quitting e-cigarettes difficult for some. In addition, vapers may be subject to social stigma, and they incur expenses for purchasing vaping devices and liquids. Many people who have taken up vaping, either to help themselves quit smoking or as a primary form of recreational drug use, would like to quit. Furthermore, some healthcare professionals are supportive of the use of e-cigarettes to quit smoking but would like their patients to stop use when they are confident they will not relapse to smoking, due to the possible risks of nicotine use.
A study recently published in is the first randomized, placebo-controlled trial to report a successful e-cigarette cessation benefit with pharmacological treatment. As a member of the Data and Safety Monitoring Committee for this study and an author on the publication, I believe the findings are an important step in addressing a relatively new source of nicotine addiction. This publication provides an opportunity for clinicians and the public health community to revisit how we think and talk about the harms associated with smoking, vaping, and nicotine addiction, and to reconsider how we can best take action to help reduce these harms.
Help or Harm: How Do We Discuss Vaping With Patients?
The fact that vaping can be associated with a high degree of dependence and a possible risk to health creates a challenge in counseling patients about their use of e-cigarettes. Given the extreme dangers associated with cigarette smoking, I believe that vaping can be a useful tool for harm reduction. I also believe that overcoming nicotine addiction -- in any form -- provides health, social, and economic benefits to those who can quit.
Healthcare professionals are solutions-oriented, and we strive to help patients set and achieve goals that can improve their physical and mental health and their quality of life. The lack of effective vaping cessation medications is an important missing piece of the puzzle when discussing the relative risks and benefits of smoking, vaping, and overcoming nicotine dependence. Survey data show that vaping nicotine plan to quit using e-cigarettes, and approximately 15% had already tried to quit in the prior year. Some succeeded, but are likely needed to help others. Is it realistic to counsel patients to quit vaping without addressing the very real biochemical basis of their nicotine addiction?
Hope for an Effective Vaping Cessation Therapy
Our data in JAMA Internal Medicine suggest we may be moving closer to finding an important intervention for e-cigarette-related nicotine dependence. The Phase II randomized clinical trial ORCA-V1 found that e-cigarette cessation rates were significantly higher for participants receiving 12 weeks of cytisinicline plus behavioral support compared with those receiving behavioral support alone. Cytisinicline is a partial agonist at α4β2 nicotinic acetylcholine receptors that mediate nicotine dependence and has shown efficacy for cigarette smoking cessation.
In the study, 160 participants were randomized 2:1 to 3 mg cytisinicline taken three times daily or placebo for 12 weeks. All participants received weekly behavioral support. The primary endpoint was biochemically verified continuous abstinence from nicotine e-cigarette use, measured during the last 4 weeks of treatment. Participants receiving 12 weeks of cytisinicline treatment had 2.6 times higher odds of having quit vaping during the last 4 weeks of treatment compared with subjects who received placebo, with vaping cessation rates during weeks 9-12 of 31.8% and 15.1%, respectively. No treatment-related serious adverse events were reported, and rates of adverse events were similar between the cytisinicline (50.9%) and placebo (54.7%) arms.
Acting Today While Awaiting Tomorrow's Advances
Although additional studies are needed to confirm the efficacy and safety of cytisinicline as a vaping cessation therapy, the ORCA-V1 results show that pharmacological tools may help to address the complex role that vaping plays in the continuum of reducing harms from cigarette smoking while sustaining nicotine addiction. These findings are particularly encouraging given the of e-cigarette use among adults -- especially -- in the U.S. Moreover, as a plant-based alkaloid, cytisinicline may appeal to those who prefer natural products as well as those who have tried and failed to quit smoking or vaping using other pharmacologic agents.
As we await additional data supporting the use of cytisinicline as a vaping cessation therapy, those of us who counsel patients who smoke cigarettes or vape nicotine should not shy away from having candid discussions about smoking, vaping, and overcoming nicotine addiction. We should be able to explain the risks and benefits of vaping and our patients' ability to make decisions that meet their personal health and lifestyle goals. With additional research, I hope those discussions will one day soon include the availability of safe and effective vaping cessation therapy.
is professor emeritus in the Department of Medicine at the University of California San Francisco.
Disclosures
Benowitz reported personal fees from Achieve Life Sciences while the JAMA Internal Medicine study was being conducted, as well as personal fees as a tobacco litigation expert witness in litigation against tobacco companies.