The effects of scheduled smoking reduction and pre-cessation nicotine replacement therapy on smoking cessation: The importance of compliance (Preprint)

Abstract

Smoking remains a significant public health problem and it is important to provide a variety of efficacious and appealing options to encourage smokers to quit. Scheduled smoking is a method of gradual reduction, preparing smokers to quit, by systematically reducing cigarette consumption according to a pre-determined schedule that increases the time between cigarettes. Gradual reduction may be preferred to abrupt quitting by some smokers, but the efficacy of this cessation approach is unclear.

The aims of the current study were 1) to evaluate the overall effectiveness of scheduled smoking alone, or in combination with pre-cessation nicotine replacement therapy (NRT), vs. standard NRT starting on the quit date with no prior smoking reduction, and 2) assess and evaluate the impact of schedule compliance on the effectiveness of the intervention.

916 participants recruited from the Houston metropolitan area were randomly assigned to one of three groups: Scheduled Smoking plus pre-cessation Nicotine Patch (SSNP; N=306), Scheduled Smoking only with no pre-cessation patch (SS; N=309) and Enhanced Usual Care (EUC; N=301). Scheduled smoking was implemented using a handheld device for 3 weeks prior to quitting. The device was used by all groups in the post-quitting phase to provide routines to manage relapse. All groups used NRT post-quit.

Participants reported an average age of 43 years old, were mostly white, were equally distributed between male and female, smoked slightly more than a pack of cigarette per day (mean = 23), and were moderately dependent on nicotine (mean FTCD score = 5). The results for aim 1 showed no overall differences in abstinence in the 3 groups in both unadjusted and adjusted (for covariates) models. However, the results for aim 2 showed a clear effect on abstinence by schedule compliance, at 2- and 4-weeks and 6-months post-quit, with the differences at 2- and 4-weeks post-quit being the most robust. In addition, we found that scheduled smoking was related to a significant reduction in several symptoms of nicotine withdrawal, negative affect, and craving versus controls.

Scheduled smoking, when combined with pre-cessation use of NRT, can result in significantly higher abstinence rates than usual care (abrupt quitting with NRT), particularly in the early post-quit phase (2 and 4-weeks post-cessation) when smokers are compliant with the procedure. There was also evidence for a clinically meaningful effect (OR>1.5) at 6-months post-quit, though statistical differences were reduced with adjustments for multiple comparisons. Scheduled smoking also produced a better overall quitting experience by reducing symptoms of nicotine withdrawal and craving, in comparison to usual care, which could encourage future quit attempts. Future studies in this area should concentrate on use of counseling or other methods to improve adherence.

This trial was not registered because data collection began prior to July 1, 2005.