Study: New Digital Tobacco Cessation Program Leads to 44% Quit Rate of Smoking Compared to Control Program


The digital cessation platform is the first FDA-cleared OTC device to help individuals quit smoking tobacco.

Individuals who used Pivot Breathe, a digital tobacco cessation program made by Pivot, reached a 44% quit rate at 1 year and demonstrated statistically superior quit rates and continuous abstinence rates when compared with the National Cancer Institute control solution, according to a statement from the company.1

Woman smoking and reading | Image Credit: marc -

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The digital cessation platform is the first FDA-cleared OTC device to help individuals quit tobacco, and includes tobacco specialist coaching, nicotine replacement therapy, online community support, and behavioral change support.1

“Pivot Breathe is a unique, evidence-based, and scalable tool to help [individuals] quit tobacco for good. Delivery of an effective preventive service upstream is always more cost-effective and clinically effective than treating the downstream complications like cancer, diabetes, emphysema, and vascular disease,” David S. Utley, MD, founder and CEO of Pivot, said in the statement.1

In the study (NCT04955639), investigators compared Pivot and QuitGuide, which was used as a control, over 52 weeks in adults who smoke and were randomized to either mobile app. The primary outcome included comparing the smoking cessation outcomes between the 2 mobile apps. The secondary outcomes include the comparison of other smoking-related behaviors and outcomes, patient feedback, and the exploratory analyses of baseline factors associated with smoking cessation.Outcomes on cessation rates included quit attempts, cigarettes, self-efficacy reports via the Smoking Abstinence Self-Efficacy Questionnaire, and nicotine replacement therapy usage.2

Cessation outcomes included the self-reported 7- and 30-day point prevalence abstinence, abstinence from all tobacco products, and continuous abstinence. These were bio-validated with witnessed breath carbon monoxide samples.2

The study authors included those who smoke cigarettes in the United States and those who were recruited online. Additionally, participants were aged 21 years or older and had smoked at least 5 cigarettes per day for the past 12 months and planned to quit smoking in the next 30 days. The patients were also comfortable using smartphones and mobile apps and were offered 12 weeks of free nicotine replacement therapy, according to the study guidelines.1,2

The data were self-reported, including a video conference bio-validation for individuals who reported 7-day point prevalence abstinence.2

There were 94 individuals included in both the Pivot group and the QuitGuide group, with 188 individuals in total. The results of the study indicated that there were higher rates of cessation in the Pivot group, with self-reported continuous abstinence of 20% compared to 9% with QuitGuide, biochemically confirmed abstinence of 31% and 18%, and biochemically confirmed continuous abstinence of 19% and 9%, respectively.2

Additionally, 99% of individuals in the Pivot group placed more nicotine replacement therapy orders, compared to 85% of those in the QuitGuide group. There was also increased self-efficacy for those in the Pivot group compared to QuitGuide.2

Additionally, those who were in the QuitGuide group made more attempts to quit smoking. Out of those not achieving abstinence, those who were in the QuitGuide group reported greater reductions in cigarettes smoked per day. For those reporting abstinence, 90% of those in the Pivot group indicated that their cessation program helped them.2

“These results add to the growing body of scientific literature on the long-term outcomes of mobile smoking cessation programs. The data [are] encouraging and consistent, pointing to a critical role these types of programs can play in the larger societal effort to curb nicotine dependence," Jennifer D. Marler, MD, vice president of Clinical & Medical Affairs at Pivot, said in the statement.1


  1. Pivot’s smoking cessation quit rate reaches 44% in randomized controlled trial, with significantly higher biovalidated quit rates than control program at one year. News release. Business Wire. August 21, 2023. Accessed August 23, 2023.
  2. Marler JD, Fujii CA, Utley MT, Balbierz DJ, Galanko JA, Utley DS. Long-term outcomes of a comprehensive mobile smoking cessation program with nicotine replacement therapy in adult smokers: pilot randomized controlled trial. JMIR Mhealth Uhealth. 2023;10.2196/48157. doi:10.2196/48157
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