Flexible, dual-form nicotine replacement therapy or varenicline in comparison with nicotine patch for smoking cessation: a randomized controlled trial

Kyuho Kim, Mercer University College of Pharmacy


Pharmacotherapy and behavioral interventions have both been found to improve smoking quit rates. A review of three studies found that combinations of nicotine replacement therapy (NRT) or varenicline are more effective than NRT monotherapy in quitting smoking. [1]

Most studies are stated to have compared standard-dose NRT or varenicline to placebo while only a few studies have compared NRT monotherapy to combinations of NRT products or varenicline. Thus, additional comparisons of these treatments are recommended to provide direct evidence of their relative effectiveness. [2]


Flexible, dual-form nicotine replacement therapy or varenicline in comparison with nicotine patch for smoking cessation
Design Randomized controlled trial; N= 737
Objective To evaluate smoking abstinence with standard nicotine patch (NRT), extended use of combined formulations of nicotine replacement therapy (NRT+), or varenicline (VR)
Study Groups NRT (n= 245); NRT+ (n= 245); VR (n= 247)
Methods NRT group: A 10-week supply of nicotine patch (Nicoderm®) patches was provided to participants.

NRT + group: Participants were encouraged to address withdrawal symptoms by titrating their NRT use up to a daily maximum of 35 mg via patches and to use nicotine (Nicorette®) gum or inhalers ad libitum.

VR: Participants assigned to the VR group began the medication varenicline (Champix®) at the baseline assessment.

Duration June 2010 to July 2014
Primary Outcome Measure Carbon monoxide-confirmed continuous abstinence rates (CAR)
Baseline Characteristics No. (%) Overall NRT NRT + VR
Cigarettes smoked per day 23.2 (10.8) 22.4 (11.3) 24.0 (10.9) 23.3 (10.1)
Fagerstrom test of nicotine dependence 6.1 (2.2) 6.0 (2.2) 6.3 (2.2) 6.1 (2.3)
Results   NRT NRT + VR p value
CAR, n (%) 23 (10) 29 (12.4) 36 (15.3) p > 0.025
Adverse Events Common Adverse Events: insomnia (NRT 37.6%, NRT + 46.9%, VR 60.3%)
Serious Adverse Events: N/A
Percentage that Discontinued due to Adverse Events: N/A
Study Author Conclusions Flexible and combination NRT and varenicline enhance success in the early phases of quitting. Varenicline improves abstinence in the medium term; however, there is no clear evidence that either varenicline or flexible, dual-form NRT increase quit rates in the long-term when compared to NRT monotherapy.



This trial shows that in comparison to a standard nicotine patch, flexible and dual-form NRT and varenicline enhances cessation in the short-term but the effect appears to wane over time. Regarding smoking cessation maintenance, use of flexible, dual-form nicotine replacement therapies or varenicline in place of standard nicotine patch was not fully conducted in this trial. Future research is needed to clarify the effectiveness of these treatments.




  1. Cahill K, Stevens S, Perera R, Lancaster T. Pharmacological interventions for smoking cessation: an overview and network meta-analysis. Cochrane Database Syst Rev. 2013; 5
  2. Mills EJ, Wu P, Lockhart I, Thorlund K, Puhan M, Ebbert JO. Comparisons of high-dose and combination nicotine replacement therapy, varenicline, and bupropion for smoking cessation: A systematic review and multiple treatment meta-analysis.Ann Med. 2012;44:588–97






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