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 (21/14/7mg) 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 4months (primary outcome) than those told to Discontinue Patch (51% vs. 46%). Most (81%) participants in the Discontinue condition stopped patch for only 1-2days and then resumed abstinence and patch use. Analyses 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.