Abstract
BackgroundNicotine replacement therapy (NRT) and varenicline are both effective in helping smokers quit. There is growing interest in combining the two treatments to improve treatment outcomes, but no experimental data exist on whether this is efficacious. This double-blind randomised controlled trial was designed to evaluate whether adding nicotine patches to varenicline improves withdrawal relief and short-term abstinence rates.Methods117 participants seeking help to stop smoking were randomly allocated to varenicline plus placebo patch or varenicline plus nicotine patch (15 mg/16 hour). Varenicline use commenced one week prior to the target quit date (TQD), patch use started on the TQD. Ratings of urges to smoke and cigarette withdrawal symptoms were collected weekly over 4 weeks post-TQD. Medication use and smoking status were established at 1, 4 and 12 weeks. Participants lost to follow-up were included as continuing smokers.Results92% of participants used both medications during the first week after the TQD. The combination treatment generated no increase in nausea or other adverse effects. It had no overall effect on urges to smoke or on other withdrawal symptoms. The combination treatment did not improve biochemically validated abstinence rates at 1 week and 4 weeks post-TQD (69% vs 59%, p=0.28 and 60% vs 59%, p=0.91, in the nicotine patch and placebo patch arm, respectively), or self reported abstinence rates at 12 weeks (36% vs. 29%, p=0.39, NS).ConclusionsThe efficacy of varenicline was not enhanced by the addition of nicotine patches, although further trials would be useful to exclude the possibility of type II error.Trial RegistrationClinicaltrials.gov Registration Number: NCT01184664
Highlights
Nicotine replacement therapy (NRT) and varenicline are both effective in helping smokers quit
On arrival at the target quit date (TQD) session, participants were sequentially allocated to the study medication by the study staff, using a list that was computer generated by the study statistician (M.S.)
Sample size Effective treatments typically generate a difference in Mood and Physical Symptoms Scale (MPSS) ratings over the first week of abstinence of at least 0.7 compared to control procedures [19], e.g. 1.8 (SD=1) compared to 2.5 (SD=1)
Summary
Design overview Objectives A double-blind randomised controlled trial was conducted to determine if combining NRT and varenicline provides better withdrawal and craving relief and higher abstinence rates than varenicline alone. Participants attended standard weekly support sessions following withdrawal-oriented treatment protocol [15] as provided by the NHS Stop-Smoking Service. Participants received two payments of £15 at sessions one and four weeks post-TQD. The Mood and Physical Symptoms Scale (MPSS) [17], which assesses tobacco withdrawal symptoms and urges to smoke was completed at all contacts. On arrival at the TQD session, participants were sequentially allocated to the study medication by the study staff, using a list that was computer generated by the study statistician (M.S.) Both participants and study staff were blind to treatment allocation. Abstinence at 24 hours and 1 week post-TQD was defined as no smoking at all, validated by expired carbon monoxide (CO) reading of
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