Smoking cessation with smokeless tobacco and group therapy: An open, randomized, controlled trial

Smokeless tobacco might be effective as an adjunct for smoking cessation. We evaluated the efficacy of smokeless tobacco and group support for smoking cessation in an open, randomized study that compared smokeless tobacco plus group support versus group support only. The study enrolled 263 healthy smokers (M age=49 years) who smoked a mean of 24 cigarettes/day, with a mean of 31 pack-years. Smokeless tobacco was provided for 7 weeks (or up to 12), combined with eight group support visits provided by nurses. The control group received group support only. Smoking cessation rates were statistically significantly better in the smokeless tobacco group than in the control group during the first 7 weeks. Point-prevalence abstinence rates at 7 weeks were 36.4% versus 20.8% (OR=2.52, p=.001), respectively; and continuous abstinence rates from weeks 4 to 7 were 31.5% versus 19.2% (OR=1.94, p=.023), respectively. The primary outcomes (i.e., 6-month point prevalence) were 23.1% versus 20.8%, respectively (OR=1.31, ns). Smokeless tobacco was relatively well tolerated, although 15 subjects (11.2%) stopped use due to adverse events. A total of 25 subjects (17.5 %) were still using smokeless tobacco after 6 months. This trial demonstrated short-term efficacy of smokeless tobacco in combination with group support for smoking cessation but no long-term efficacy.