In the largest ever head-to-head randomized trial of medications that help smokers quit, a combination of a nicotine lozenge and patch appears to provide the greatest benefit. While all medications were more effective than placebo, the patch plus lozenge was the only intervention to significantly help people abstain from cigarettes after 6 months.
The study, published in the Archives of General Psychiatry, included 1504 smokers randomly assigned to receive 1 of 5 medication options or a placebo. All of the participants had smoked at least 10 cigarettes a day during the previous 6 months and were motivated to quit. The patients in the medication groups received 8 to 12 weeks of treatment with a placebo or: (1) a nicotine patch; (2) a nicotine lozenge; (3) bupropion, which is an antidepressant; (4) a combination of the patch plus the lozenge; and (5) a combination of the lozenge plus bupropion. In addition, all participants received 6 personal counseling sessions to help them quit. Investigators looked at quit rates at several intervals, including the first week after the quit date, at the end of treatment, and at 6 months following treatment. All participants’ self-reports of smoking status during study visits were confirmed by a machine that measured expired carbon monoxide levels to < 10 parts per million (ppm).
Using a statistical significance of P<0.0045, all interventions except the lozenge were effective at the end of the first week compared with placebo. At the end of 8 weeks, the patch and the combination therapies offered significant rates of cessation. At 6-months post quitting, only the patch plus the lozenge showed a significant improvement versus placebo (P<0.001). The success rate for the various interventions ranged from 22.2% (placebo), 31.8% (bupropion), 33.5% (lozenge), 34.4% (patch), 33.2% (lozenge plus bupropion), to 40.1% (lozenge plus patch). The lozenge plus patch group was also the most successful in helping smokers achieve at least 1 smoke-free day in the first week after quitting, which is considered an important step to long-term success. Adverse events occurred in a pattern similar to those with prior research and included skin irritation (patch), sleep disturbances (bupropion), and nausea (lozenges). The patients on combination therapy cited more adverse events than those on monotherapy or placebo.
The limitations to the study include the short length of the study and the fact that researchers did not look at other common smoking cessation aids, including nasal sprays, inhalers, and nicotine gum. Varenicline (ChantixTM) was not included because it had not yet been FDA approved when the study began.