di , 21/08/2023

REDWOOD CITY, Calif.–(BUSINESS WIRE)–Pivot, a behavioral change digital health company, today published long-term results from a randomized controlled trial (RCT) of Pivot Breathe, its digital tobacco cessation program. The digital platform provides evidence-based tobacco cessation interventions via an easy-to-use app, the first ever FDA cleared over-the-counter device to help people quit tobacco, tobacco specialist coaching, nicotine replacement therapy, online community support, and behavioral change support.

The study compared Pivot Breathe to QuitGuide, the gold standard, digital smoking cessation solution from the National Cancer Institute (NCI). Pivot participants reached a 44% quit rate at 1 year, and demonstrated statistically superior biovalidated quit rates and continuous abstinence rates over the NCI control solution.

While tobacco use in the U.S. has decreased since its historic highs in the 1960s, smoking still remains the single greatest cause of preventable illness and death with one in eight US adults smoking cigarettes every day. Further, e-cigarette use and vaping are on the rise, with that market projected to grow 30% between 2023 and 2030. “Smoking combustible tobacco remains a public health crisis and therefore it should be our number 1 public health priority to help people quit smoking. Cigarettes are a causative agent in nearly all of the highest cost chronic health conditions,” said David S. Utley, M.D., founder and CEO of Pivot.

Pivot’s newest study documents how an effective smoking cessation program can turn the tide. “Pivot Breathe is a unique, evidence-based, and scalable tool to help people 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,” says Utley.

The randomized controlled trial, published in JMIR mHealth and uHealth, evaluated health outcomes in 188 adults twelve months after enrollment in either the Pivot program or the NCI’s QuitGuide (“the control arm”). Key findings include:

  • Biovalidated quit rates at 12, 26 and 52 weeks were significantly higher in the Pivot arm vs. the NCI control arm.
  • Pivot demonstrated a continued increase in quit rate between 26 and 52 weeks; 38% to 44% respectively. For context, durable quit rates for a cold turkey quit attempt average 3-5%.
  • Biovalidated continuous abstinence rates for Pivot were 2x that of the NCI control arm at 12 months, demonstrating durability of quit.
  • Confidence in one’s ability to quit is a key indicator for success. From baseline to 12 months, Pivot users’ confidence to quit increased significantly.
  • For those Pivot users who had not achieved complete abstinence, 38% had reduced cigarettes per day by ≥50%.

“These results add to the growing body of scientific literature on the long term outcomes of mobile smoking cessation programs. The data is encouraging and consistent, pointing to a critical role these types of programs can play in the larger societal effort to curb nicotine dependence,” said Jennifer D. Marler, M.D., VP Clinical & Medical Affairs at Pivot.

Participants were 21 or older and had smoked at least five cigarettes per day for the past 12 months. They also planned to quit smoking in the next 30 days and were comfortable using smartphones and apps. In addition, participants were offered 12 weeks of free nicotine replacement therapy. The RCT measured outcomes for engagement and retention, attitudes towards quitting smoking, smoking behavior, and participant feedback. The full abstract can be found here.

About Pivot

Pivot is a behavioral change digital health company focused on helping millions of people live longer, better lives. At the core of Pivot Breathe and Pivot Flex is a powerful behavior change platform offering human coaching, a supportive community and a mobile app experience with tailored behavioral change content, tools and challenges for each unique journey. Pivot Breathe, a best-in-class solution, addresses cessation for all forms of tobacco (combustible, vaporized, and smokeless) and provides the first ever FDA-cleared over the counter device to help people quit tobacco as well as pharmacotherapy. Pivot Flex supports individuals seeking a healthier relationship with stress, using the core fundamentals of cognitive behavioral therapy and Pivot’s proprietary Flex Assessment, which provides a way to track and see improvements. Pivot is HIPAA-compliant and has obtained SOC 1 and SOC 2 clearance. For more information, please visit: https://pivot.co/.


Kate Cote – VP of Marketing