NEW YORK--(BUSINESS WIRE)--Click Therapeutics, Inc. (“Click”), a company developing a suite of personalized data-driven digital therapeutics for chronic health conditions, announces today preliminary results of its fully remote clinical trial of Clickotine, a digital program designed for smoking cessation.
The study was conducted to investigate the feasibility of a fully digital clinical trial, to validate the engagement of the CLICK Neurobehavioral Intervention (CNI) Platform, and to explore the efficacy of Clickotine for smoking cessation. Primary outcome of the study was user-engagement, with additional outcomes measuring smoking behavior and safety.
In a digital, 8-week, IRB-approved open-label clinical trial, Clickotine was provided to 416 participants who enrolled in the trial over the 9-week period of recruitment. In response to advertisements and postings on social media platforms, 617 potential users responded and were contacted by study staff to confirm eligibility. Of 452 potentially eligible participants who had indicated interest, 416 participants provided informed consent digitally and enrolled in the trial, yielding a 92% conversion rate. Participants had been smoking 16.7 cigarettes per day for 18.1 years on average. Study interventions and assessments were delivered digitally, and procedures for medical monitoring and biochemical verification of smoking cessation were in place throughout the study. All data were digitally captured and stored in the secure study database.
365 of the 416 participants completed the trial (defined as providing informed consent, downloading the app, and completing both the baseline and 8-week questionnaires), representing an 87.7% completion rate. According to Nicholas Schork, Ph.D., the Principal Investigator of the Clickotine trial and also a Professor at the J. Craig Venter Institute as well as the Translational Genomics Research Institute: “This study demonstrates the potential of conducting a trial of a therapeutic intervention digitally. The user engagement, data integrity, and efficiency provided by the Click platform were exceptional.” The clinical utility of the CNI platform, an abstract describing the study design and methodology, and preliminary results will be presented at the upcoming CNS Summit 2016 in Boca Raton, FL, October 27-30.
The preliminary results exceeded expectations in many areas:
- Participants opened the Clickotine application 100.5 times on average over the 8-week study period.
- Participants performed an additional 130.4 substantive interactions with the program on average; common interactions included replying to personalized messages, tracking cigarettes and cravings, controlled breathing exercises, and completing missions.
- 45.2% of participants (n=188) had stopped smoking at the end of the study (no cigarettes, not even a puff, for at least 7 days).
- 26.2% of participants (n=109) achieved 30-day sustained abstinence after 8 weeks.
- Follow-up will assess whether abstinence is maintained after 24 weeks.
Association between engagement and smoking cessation
- Participants who remained engaged at the end of the 8-week study period were 2.4 times more likely to achieve 30-day sustained abstinence than those who did not (p<0.0001).
Click is planning a large-scale randomized controlled clinical trial to confirm these results placing Clickotine among the most effective smoking cessation interventions available, including prescription medications, nicotine replacement therapy (NRT) and other smoking cessation applications. Click is currently exploring combination therapies with NRT and pharmacologic agents to optimize treatment strategies for smoking cessation. The commercial version of Clickotine, available nationally through a partnership with Magellan Health to its employer, managed care and government customers, includes directly integrated access to live coaching and NRT, neither of which was provided as a component of this clinical study.
Click is also pursuing additional opportunities to optimize and expand its platform. This includes initiatives to develop digital interventions for other forms of addiction, and chronic health conditions such as depression, insomnia, chronic pain, and obesity. Click has established an industry partnership which will facilitate the dissemination, testing and further development of its platform to enhance treatment adherence and provide meaningful, quantifiable clinical outcomes for depression. Furthermore, the company is collaborating with top researchers from academia to develop and study the platform for the treatment of insomnia.
Click is planning additional studies to validate the program in a variety of special populations including diabetics, pregnant women, COPD and presurgical patients. The company is providing the platform, along with de-identified clinical data, selectively to researchers interested in investigator-initiated studies for smoking cessation and other chronic health conditions. Click is also in the process of expanding the program internationally through partnerships in Europe and Asia.
"We are thrilled to report outstanding engagement and clinical outcomes data on Clickotine, our comprehensive digital therapeutics program for people who want to quit smoking. These data reinforce the utility and effectiveness of Click's mobile patient-centered technology platform as a powerful tool in the transition to value-based care, enabling real-time clinical solutions for earlier and more effective interventions that can transform the delivery and cost of care. We plan to leverage the CNI platform which comprises our best-in-class user engagement, machine learning and behavior change expertise to provide digital precision medicine for a wide variety of individual needs," said David Benshoof Klein, Click Therapeutics’ CEO.
About Click Therapeutics
Click Therapeutics, Inc. engineers, validates, and commercializes Digital Therapeutics™ solutions to benefit people with unmet medical needs through cognitive and neurobehavioral modification. Click Therapeutics™ digital interventions enable change within individuals, and can be used independently or in conjunction with biomedical treatments. The Clickometrics® adaptive data science platform continuously personalizes user experience to drive cognitive and behavioral outcomes. As the leader in Digital Therapeutics™ solutions, Click Therapeutics is building the brains behind digital health. For more information, visit ClickTherapeutics.com.