Smoking cessation during alcohol treatment: a randomized trial of combination nicotine patch plus nicotine gum.

Although cigarette smoking prevalence among U.S. adults has declined to 21 percent (1), the majority of individuals with alcohol problems remain current smokers (2, 3). The negative health consequences of smoking among alcohol abusers are substantial. A longitudinal study of an alcohol treatment sample indicated that smoking killed more alcoholics than did alcohol (4). The United States Department of Health and Human Services (USDHHS) Clinical Guideline for Treating Tobacco Use and Dependence provided a consensus recommendation that smokers receiving treatment for chemical dependency should be provided smoking cessation treatments including both counseling and pharmacotherapy (5). These Guideline recommendations have not led to significant changes in clinical practice. Fuller and colleagues (6) recently surveyed 342 substance abuse treatment units and found that 235 (69%) offered no treatment for nicotine dependence. Studies have evaluated smoking cessation interventions for individuals with alcohol and drug problems. Although one review found that smokers with past alcohol problems were as likely to stop smoking on a given quit attempt as smokers without alcohol problems (7), another review (8) concluded that smoking cessation rates tended to be low among individuals in early substance abuse recovery and increased with length of sobriety. A meta-analysis of 11 studies of smoking cessation during substance abuse treatment (9) found long term smoking abstinence rates of 7% in the intervention groups and 6% in the comparison conditions with a summary risk ratio of 1.00. These reviews, taken together with USDHHS clinical practice guideline recommendations, suggest the need to develop more effective smoking cessation interventions for use during alcohol and drug treatment with individuals in early recovery. Smokers with alcohol problems might have a greater need for pharmacotherapy to assist cessation compared to smokers without alcohol problems. Smokers with a history of alcoholism tend to have more severe nicotine dependence (7). They reported a greater preference for active nicotine gum and self-administered more milligrams of nicotine than smokers without a history of alcoholism (10), suggesting that nicotine was more reinforcing in smokers with a history of alcoholism than in smokers without this history. Among alcohol dependent smokers who received concurrent alcohol and smoking cessation treatment, increased cigarette craving was a significant antecedent to both tobacco and alcohol relapse (11). This finding suggests the possibility that pharmacotherapy to control cigarette craving could reduce relapse risk for both substances. It is reasonable to hypothesize that higher dose nicotine replacement may improve smoking cessation treatment efficacy for alcoholic smokers. However, a study conducted with smokers with a history of alcohol dependence found that high dose nicotine patch therapy (42 mg) was not more effective than standard 21 mg dose (12). It has been suggested that smokers might benefit from both a constant level of nicotine (nicotine patch) to relieve symptoms of withdrawal and craving, in combination with a self-administered, self-titrated, faster acting preparation (e.g., nicotine gum) for more immediate relief of breakthrough craving to smoke (13). Clinical trials suggest higher efficacy of this type of combined nicotine replacement therapy in studies of smokers without alcohol problems (14). Although combination nicotine replacement therapy is not FDA approved, the 2008 update of the DHHS Clinical Guideline for Treating Tobacco Use and Dependence (15) included the combination of nicotine patch and other ad libitum nicotine replacement on its list of recommended pharmacotherapies. The meta-analysis included in the Guideline update found that this combination yielded an odds ratio of 3.6 compared to placebo. This odds ratio appeared to be higher than any other monotherapy or combination therapy examined. A recent preference study compared combination nicotine treatments (patch/patch vs. lozenge/patch vs. inhaler/patch vs. gum/patch) and found that the combination of nicotine gum and patch received overall better preference ratings than the alternatives across measures of “ease of use”, “use under stress”, and “help to quit” (16). The primary aim of our study was to compare the efficacy of smoking cessation treatment using active nicotine patch and active nicotine gum (NP+NG) versus therapy consisting of active nicotine patch and placebo nicotine gum (NP+PG) in a sample of alcohol dependent tobacco smokers in an early phase of outpatient alcohol treatment. A secondary aim was to determine whether or not there are any carryover effects of combination nicotine replacement on drinking outcomes.