Phase II study to assess the benefit of very low nicotine cigarettes as a smoking cessation treatment
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Background . Nicotine replacement therapy can enhance the chance of quitting by reducing withdrawal symptoms. Craving for smoking may be a response to exposure to environmental factors that have been linked with long-term smoking behavior. Attenuation of craving for smoking in response to cue exposure may have additional value for aiding smoking cessation. Objective . The primary objective of the study was to assess if craving for smoking could be reduced by pre-treating smokers with two weeks of very low nicotine cigarettes (Quest 3) plus the nicotine patch prior to the quit date as compared to those smokers who smoked a light cigarette brand (Quest 1) prior to their quit date. Methods . A randomized controlled trial was carried out to test the hypothesis that Quest 3 plus patch can reduce craving for smoking. Ninety-eight subjects, recruited from October 2004 to January 2005, were randomly assigned to one of two groups. Half of the subjects received very low nicotine cigarettes (Quest 3) plus 21 milligram nicotine patches for two weeks before the quit date. The other half received light cigarettes (Quest 1) for two weeks before the quit date. After the quit date both groups received 21 milligram nicotine patches for four weeks, followed by two weeks of 14 milligram nicotine patches, and two more weeks of 7 milligram nicotine patches. In total, eight weeks of nicotine replacement therapy was provided following the quit date. All subjects also received standard behavioral counseling. Data on smoking behavior was collected at the following contacts: (a) the baseline visit; (b) three phone surveys in the two weeks prior to the quit date; (c) the quit date visit; (d) three phone surveys in the two weeks after the quit date; (e) follow up visits scheduled 2, 4, and 6 weeks after the quit date; and (f) phone surveys scheduled at 12 and 24 weeks after the quit date. Primary outcome measure was self-reported craving for smoking as determined during the two weeks before and after the quit date from surveys completed during phone interviews and clinic visits. Measures of craving included intensity and frequency of cravings and scores for craving for smoking in different daily situations. Other measures of smoking behavior included subjective reports on the effects of smoking and smoke intake as well as withdrawal symptoms and amount smoked. The point prevalence of abstinence from smoking was determined based on self-report during phone surveys scheduled 12 and 24 weeks after the quit day. Linear mixed model method was used for analysis of repeated measurements on study outcomes. Chi-square test was used to compare the two arms of the study in regard to point prevalence of smoking abstinence at 12 and 24 weeks. Results . The group treated with Quest 3 plus patch had a lower combined craving score during the two weeks before (beta=-17, p<0.001) and after (beta=-8, p=0.013) the quit date. The strength of craving was 1.4 points lower in the Quest 3 plus patch group during the two weeks before the quit date (p<0.001). This scale continued to be lower during the two weeks after the quit date but the difference between the two arms of the study was reduced to 0.8 points (p=0.008). The frequency of craving for smoking in the Quest 3 plus patch group was 1.7 points lower during the two weeks before the quit date (p<0.001) and it was 0.8 points lower during the 2 weeks after the quit date (p=0.003). The group treated with Quest 3 plus patch was 3.6 points lower for craving smoking in different daily situations at the quit date visit (p<0.001) and 3.2 points lower for craving smoking in different daily situations at the follow up visit 2 weeks after the quit date (p=0.012). The two groups were similar in regard to the withdrawal score during the two weeks before and after the quit date (p>0.05). The group treated with Quest 3 plus patch was about 4.0 points lower for inhalation impact (p=0.006) and also lower for smoke intake (p=0.003) during the two weeks before the quit date. The Quest 3 plus patch group had a higher quit rate at 12 weeks (43% versus 34%) and at 24 weeks (28% versus 21%) but these differences were not significant (p>0.05). Restricting the analysis to subjects who were able to abstain from smoking for at least a day after the quit date did not change any of the findings. Conclusion . The findings suggest that use of combination of Quest 3 plus nicotine patch for two weeks before the quit date can reduce the craving for smoking and this may be able to aid smoking cessation. Additional work is needed to confirm these findings and further research the utility of treatment before the quit date for extinction of smoking behavior.