Effectiveness of continuing nicotine replacement after a lapse: A randomized trial

Introduction: Four post-hoc analyses of prior trials found smokers using nicotine patch following a lapse were less likely to progress to relapse compared to those using a placebo patch following a lapse. We attempted a conceptual replication test of these results via a randomized trial of instructions to continue vs. stop nicotine patch after a lapse. Methods: Smokers trying to quit (n = 701) received nicotine patch (21/14/7 mg) and brief phone counseling (six 15-min sessions). We randomized smokers to receive instructions for and rationale for stopping vs. continuing patch after a lapse. The messages were repeated before and after cessation and following lapses via counseling, phone and written instructions. Results: Among those Who lapsed, those told to Continue Patch did not have a greater incidence of 7-day abstinence at 4 months (primary outcome) than those told to Discontinue Patch (51% vs. 46%). Most (81%) participants in the Discontinue condition stopped patch for only 1-2 days and then resumed abstinence and patch use. Analydes based on all participants randomized were similar. Adverse events were as expected and did not differ between conditions. Conclusion: Instructions to continue nicotine patch after a lapse did not increase return to abstinence. These negative results may have occurred because actual use of patch after a lapse was similar in the two conditions. Also, allowing patch use while smoking may have reduced motivation to stay abstinent.