University of Oklahoma Conducts Phase 2 Clinical Trial for Smoking Cessation

Strategic Insights -

Researchers at the University of Oklahoma have initiated a Phase 2 clinical trial to study the combination of varenicline and nicotine lozenges, along with a smartphone medication adherence intervention, to promote smoking cessation. The trial aims to recruit 496 participants from the USA and will evaluate the effectiveness of this combination therapy in improving smoking cessation rates.

Key Takeaways:

  • The trial focuses on assessing the combination of varenicline and nicotine lozenges, along with a smartphone medication adherence intervention, to promote smoking cessation in 496 participants from the USA.
  • The study aims to evaluate the primary outcomes of biochemically-confirmed 7-day point prevalence abstinence at 26 weeks after a scheduled quit date and medication adherence over the 13-week treatment period.
  • The trial employs a 2x2 factorial design, randomizing participants to one of four combinations of treatment factors: varenicline + nicotine lozenges vs. varenicline alone and smartphone-based smoking cessation app with vs. without adherence components.
  • Smartphone-based daily diaries will be used to assess daily smoking and medication adherence.
  • Exploratory analyses will evaluate the potential interaction between medication type and the smartphone adherence intervention and compare the influences of pharmacological treatment type and the medication adherence intervention on weekly physical symptoms.

Statistics:

  • The trial aims to recruit 496 participants from the USA.
  • The study will evaluate the primary outcomes of biochemically-confirmed 7-day point prevalence abstinence at 26 weeks after a scheduled quit date and medication adherence over the 13-week treatment period.
  • 85% of U.S. adults own smartphones, which could positively influence pharmacotherapy adherence and smoking cessation.
  • The trial will employ a 2x2 factorial design, randomizing participants to one of four combinations of treatment factors.

Sources:

  • ClinicalTrials.gov
  • Contify.com (Copyright 2017)