May 18, 2010 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 5-10 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).
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- Gary E. Swan, Jennifer B. McClure, Lisa M. Jack, Susan M. Zbikowski, Harold S. Javitz, Sheryl L. Catz, Mona Deprey, Julie Richards, Timothy A. McAfee. Behavioral Counseling and Varenicline Treatment for Smoking Cessation. American Journal of Preventive Medicine, 2010; 38 (5): 482 DOI: 10.1016/j.amepre.2010.01.024
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