An Effectiveness Trial of Maintenance Therapy for Nicotine Dependence

The transdermal nicotine patch is the most widely used form of tobacco dependence treatment
in the US and Europe. Yet, abstinence rates following patch treatment are only ~20% at
6-months and ~9% at 12-months. There is a growing recognition that nicotine dependence is a
chronic disease, like asthma or diabetes, which requires maintenance therapy. While current
guidelines established by the USDHHS's Public Health Service (PHS) recommend 8-week duration
for transdermal nicotine therapy, support for this recommendation is limited. In a recent
randomized placebo-controlled efficacy trial comparing standard (8-week) vs. extended
(24-weeks) treatment with nicotine patches, we found that, at 24 weeks, point-prevalence
abstinence rates were 30% in the 24-week arm vs. 20% in the standard therapy arm (p < .05);
however, by week 52, 6 months after treatment was discontinued for the extended treatment
arm, the quit rates were equivalent across the treatment arms. This was the first clinical
trial to suggest that the benefits of extended treatment with transdermal nicotine are
largely dependent on the continuation of active treatment. However, as an efficacy trial,
this study was conducted under highly-controlled conditions with strict inclusion/exclusion
criteria to enhance internal validity. If recommendations for the duration of nicotine patch
therapy are to be formally revised to encourage maintenance therapy, these findings must be
replicated and extended under "real-world circumstances" in an effectiveness trial. In
addition, as done in clinical trials to support the use of methadone maintenance for opiate
dependence, a replication study must include a treatment arm that receives maintenance
therapy throughout the duration of the trial (52 weeks). Thus, we propose to conduct a
randomized effectiveness trial to evaluate the benefits of maintenance therapy with
transdermal nicotine patches for smoking cessation. Specifically, 540 smokers will receive
brief counseling and will be randomized to: standard (8-weeks), extended (24-weeks), or
maintenance (52 weeks) transdermal nicotine therapy. The primary outcome will be
biochemically verified 7-day point prevalence abstinence at week 52. Additional study aims
include assessing: 1) treatment side effects across study arms; 2) longitudinal patterns of
relapse and recovery across treatment arms; 3) mediators and moderators of treatment
effects; and 4) cost-effectiveness. Overall, the trial findings will provide critical data
for future PHS reviews of maintenance therapy with transdermal nicotine for subsequent
treatment guidelines; for third-party payer assessments of maintenance transdermal nicotine
as a covered benefit; and for individual smokers' decisions to use maintenance transdermal
nicotine through over-the-counter access. In turn, this study may help to attain the Healthy
People 2010 goals of reducing the US rate of tobacco use.

Inclusion Criteria: Participants will be: 1) males and females over age 18 who smoke at
least 10 cigarettes/day; 2) able to communicate in English; 3) able to use NRT safely
(e.g., no allergy to latex, no serious abnormal ECG reading); 4) able to provide written
informed consent for study procedures; and 5) residing in the geographic area for at least
12 months.

Exclusion Criteria: Participants will be ineligible for the trial if they: 1) are unable
to communicate in English; 2) Have a current diagnosis of psychosis and/or manic
depression; 3) have a current medical condition that would make using transdermal nicotine
patch unsafe (e.g., allergy to latex, serious, abnormal ECG reading)- participants with
asthma, diabetes, hypertension, or heart disease (e.g., coronary artery disease, abnormal
heart rhythm, an arrhythmia) will be permitted to enroll in the study with medical
clearance from the participant's physician or the study physician; 4) have had a heart
attack within the past 6 months, 5) are pregnant or planning to become pregnant or
lactating, or 6) are currently enrolled or plan to enroll in another research or smoking
cessation program within the next 12 months.