A randomized trial compared three ways to deliver a behavioral smoking cessation program using varenicline (Chantix®): by phone, Web, or both. Although phone counseling had greater treatment advantage for early cessation and appeared to increase medication adherence, abstinence outcomes did not differ at six months.
The findings suggest the three programs are all effective treatment options when combined with varenicline. Nonprofit scientific research institute SRI International, Group Health Research Institute, and Free & Clear, Inc. conducted the trial, published in the May 2010 American Journal of Preventive Medicine.
Proactive telephone behavioral counseling and Web-based services are popular tools for smoking cessation. Although both phone- and Web-based services are known to be effective, previous studies have not examined whether combining these services improves outcomes over either method alone. The trial aimed to determine the relative effectiveness of a widely used smoking cessation program (Free & Clear Quit For Life® Program) delivered in three ways: standard proactive telephone behavioral counseling, Web-based delivery, and a program that combined the two.
The trial was among the first "real-world" examinations of varenicline use since the original phase III studies that the manufacturer sponsored. The researchers tracked more than 1,200 Group Health adult patients who received behavioral therapy and varenicline to quit smoking. All participants received 12 weeks of varenicline, printed guides, a 5 minute orientation call, and access to a toll-free phone number for support as needed.
"Our findings provide important data regarding the real-world use of varenicline and show that a supportive treatment philosophy along with individualized information matter most for long-term smoking cessation success," said Gary Swan, PhD, director of the Center for Health Sciences at SRI International and lead author of the study. "Any of the programs shows promise as a counseling tool when used in combination with varenicline."
Varenicline is a non-nicotine prescription medicine specifically developed to help adults 18 and older quit smoking. It targets nicotine receptors in the brain, attaches to them, and blocks nicotine from reaching them. Based on the observed smoking abstinence outcomes, researchers found that data obtained in real-world behavioral therapy settings are comparable to those from the varenicline phase III clinical trials. Gastrointestinal disturbances and abnormal dreams were the most common varenicline side effects, similar to the proportion of study participants reporting side effects in the phase III trials. No serious neuro-psychiatric incidents attributable to varenicline use occurred during the trial.
Co-authors were Group Health Research Institute Senior Investigator Jennifer B. McClure, PhD, and Associate Investigator Sheryl L. Catz, PhD; Project Manager Julie Richards, MPH; and Affiliate Investigators Susan M. Zbikowski, PhD, and Timothy A. McAfee, MD, MPH, both of Free & Clear; Mona Deprey, MS, of Free & Clear; and Lisa M. Jack, MA, and Harold S. Javitz, PhD, of SRI International.
The project described is registered at www.clinicaltrials.gov (NCT00301145). It was 97.85 percent funded ($3.3 million) by the National Cancer Institute (Grant R01CA071358). Pfizer Inc. provided study medication and nominal support (2.15%) for recruiting participants ($72,000).
Silicon Valley-based SRI International is one of the world's leading independent research and technology development organizations. SRI, which was founded by Stanford University as Stanford Research Institute in 1946 and became independent in 1970, has been meeting the strategic needs of clients and partners for more than 60 years. Perhaps best known for its invention of the computer mouse and interactive computing, SRI has also been responsible for major advances in networking and communications, robotics, drug discovery and development, advanced materials, atmospheric research, education research, economic development, national security, and more. The nonprofit institute performs sponsored research and development for government agencies, businesses, and foundations. SRI also licenses its technologies, forms strategic alliances, and creates spin-off companies. In 2008, SRI's consolidated revenues, including its wholly owned for-profit subsidiary, Sarnoff Corporation, were approximately $490 million.
Free & Clear, Inc.
Free & Clear, a wholly owned subsidiary of Alere LLC and its parent company, Inverness Medical Innovations, is a healthy behaviors company specializing in phone-based cognitive behavioral coaching, Web-based e-learning, and training and technical assistance. Free & Clear's evidence-based programs address the four key modifiable health risks that contribute to chronic disease: tobacco use, poor nutrition, physical inactivity, and stress. Free & Clear's tobacco cessation program evolved 25 years ago out of research funded by the National Cancer Institute to test the effectiveness of telephonic smoking cessation treatment. The Since that time Free & Clear has established itself as the national leader in tobacco dependence treatment. Free & Clear is a committed to the advancement of the science of tobacco prevention and cessation. We have conducted more than 20 clinical trials and contributed to more than 100 peer-reviewed scientific publications.
Group Health Research Institute
Founded in 1947, Group Health Cooperative is a Seattle-based, consumer-governed, nonprofit health care system. Group Health Research Institute changed its name from Group Health Center for Health Studies in 2009. Since 1983, the Institute has conducted nonproprietary public-interest research on preventing, diagnosing, and treating major health problems. Government and private research grants provide its main funding.
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