Abstract
OBJECTIVES: There is a critical need for the development of novel treatments for nicotine dependence. Because the majority of smokers who make a quit attempt fail within 7 days, medication screening procedures that focus on this early cessation period may provide an indicator of treatment efficacy. To establish the clinical validity of this paradigm, it is critical to demonstrate the association of early abstinence with longer-term abstinence. We tested the number of days of abstinence during the first week after the target quit date (TQD) as a predictor of point prevalence abstinence in 3 independent pharmacotherapy trials for nicotine dependence. METHODS: This was a secondary data analysis of 3 randomized clinical trials: a placebo-controlled trial of transdermal nicotine (N = 545); an open-label nicotine replacement therapy (patch vs spray) trial (N = 566); and a bupropion placebo-controlled trial (N = 538). In separate logistic regression models, the maximum number of consecutive days of abstinence during the first week after the TQD was used to predict biochemically verified 7-day point prevalence abstinence at the end of treatment (EOT) and 6 months post-TQD. RESULTS: Across the 3 trials, the number of days of abstinence significantly predicted abstinence at EOT and 6 months (odds ratios > 1.4; Ps < 0.0001). Likewise, not having any lapse during the first week predicted abstinence at EOT and 6 months (odds ratios > 4.7; Ps < 0.0001). CONCLUSIONS: The first week of abstinence was highly predictive of EOT and long-term abstinence. Medication screening procedures that focus on this early abstinence period (ie, 6 or 7 days of consecutive abstinence) represent a valid tool for assessing the presence of a signal for medication efficacy.