Research

Intervention

Nicotine Lozenge

BACKGROUND: Authors tested the safety and efficacy of a new nicotine polacrilex lozenge for smoking cessation using a double-blind, placebo-controlled, randomized clinical trial with parallel arms testing 2- and 4-mg nicotine lozenges. Smokers (n=1818) were assigned to a lozenge dose on the basis of nicotine dependence, assessed by time to the first cigarette of the day. Low-dependence smokers were randomized to receive the 2-mg nicotine (n=459) or placebo (n=458) lozenge; high-dependence smokers, the 4-mg nicotine (n=450_ or placebo (n=451) lozenge. We assessed abstinence at 6, 12, 24, and 52 weeks and analyzed craving and withdrawal symptoms.

RESULTS: Treatment with the nicotine lozenge resulted in significantly greater 28-day abstinence at 6 weeks, for the 2-mg (46.0% vs 29.7%; odds ratio (OR), 2.10) and the 4-mg lozenges (48.7% vs 20.8%; OR, 3.69), compared with placebo. Significant treatment effects were maintained for a full year. Smokers who used more lozenges achieved significantly better treatment effects. Use of the active lozenge also resulted in reduced craving and withdrawal. Most adverse events were moderate and resembled those seen with nicotine gum.

(Nicotinell mint lozenge containing 1 mg nicotine (Pharmacia) is available in Europe and under review in the U.S.)

Shiffman, S., et al. (2002). “Efficacy of a nicotine lozenge for smoking cessation.” Archives of Internal Medicine,162(11):1267-1276.

Bupropion (Zyban) and Previous NRT

BACKGROUND: This study examined previous use of nicotine replacement therapy (NRT) on the smoking-cessation efficacy of bupropion sustained release (SR). Secondary analysis of a parallel-group, randomized, double-blind, placebo-controlled study was used. Smokers who had, based on self-report, no previous history of NRT (N=453) or who had used NRT at least once (N=440) were randomized to receive placebo, bupropion SR, nicotine transdermal system (NTS), or a combination of bupropion SR and NTS.

RESULTS: Bupropion SR showed similar efficacy in participants with or without previous use of NRT. The article concluded that Bupropion SR is effective in promoting smoking abstinence regardless of prior NRT use.

Durcan M.J., et al (2002). Impact of prior nicotine replacement therapy on smoking cessation efficacy.” American Journal of Health Behavior, 26(3):213-220.

Gender and Relapse Prevention

BACKGROUND: Recent data suggest that women smokers respond differently than men to cessation pharmacotherapies, particularly nicotine replacement therapy (NRT). Lower abstinence and higher relapse rates are often reported for women treated with NRT. Gender effects for those treated with non-nicotinic, bupropion sustained release for relapse prevention have not been studied.

METHODS: Data from a multicenter relapse-prevention (RP) trial of bupropion (November 1995-June 1998) were analyzed for gender differences. Men and women smokers (N=784) were treated with open-label bupropion for 7 weeks. Those abstinent at Week 7 (n=432) were enrolled in the double-blind relapse-prevention phase and randomized to placebo or continued bupropion for 45 additional weeks.

RESULTS: Differences in point-prevalence abstinence rates between men (61.8%) and women (55.6%) in open-label bupropion at Week 7 were not significant. In the RP-phase Week 52, continuous abstinence rates for men and women were 37.8% and 36.4% (bupropion) and 36.6% and 29.9% (placebo), respectively. Point-prevalence abstinence rates for men and women were 54.1% and 55.9% (bupropion) and 42.9% and 41.3% (placebo), respectively. Abstinence rates and time to relapse were superior for both men and women who received longer treatment. Gender differences within treatment groups were not significant. Median time to relapse was similar for men and women within each treatment group: Week 32 for bupropion and Week 20 for placebo.

CONCLUSION: Our data suggest that bupropion is a promising pharmacotherapy for preventing relapse, particularly for women.

Gonzales, D et al. (2002). Effects of gender on relapse prevention in smokers treated with Bupropion SR. American Journal of Preventive Medicine, 22: 234-239.

Managed Care & Tobacco Control

BACKGROUND: Although evidence-based national guidelines for tobacco-dependence treatment have been available since 1996, translating these guidelines into clinical practice is challenging. Policies regarding tobacco-dependence treatment (e.g., written guidelines and coverage of pharmacotherapy) and implementation strategies of 11 U.S. managed care organizations known to have strong tobacco-control programs were examined via detailed telephone interviews with multiple informants and review of written treatment guidelines and policies for tobacco dependence.

RESULTS: Although 10 of 11 plans had adopted tobacco-dependence treatment guidelines consistent with the national guideline, fewer had guidelines for special groups, such as adolescents (6 plans), parents (5 plans), pregnant women (5 plans), and hospitalized smokers (3 plans). Most plans offered clinician training and recommended office systems to support provider efforts; however, fewer actively facilitated their implementation. Most plans provided other support for tobacco treatment, including dedicated budgets, designated staff, and an oversight committee. All plans offered some coverage for tobacco-cessation pharmacotherapy and behavioral counseling, although not to the extent recommended by the national guideline. Implementation of national tobacco-treatment guidelines is feasible in closed-panel managed care organizations. According to the authors, even these leading health plans could do more to comply with national practice guidelines on tobacco-dependence treatment and make it easier for clinicians to help patients stop smoking (e.g., through increased training and expanded coverage of tobacco-dependence treatment).

Rigotti, N.A., et al. (2002). “Tobacco-control policies in 11 leading managed care organizations: progress and challenges.” Effective Clinical Practice, 5(3): 130-6.

Benefits of Nicotine Replacement Available Over-the-Counter

BACKGROUND: This paper provides an analysis of the benefits to society from the conversion of nicotine replacement drugs (nicotine patches and gum) in 1996 from sale by prescription only in the United States to over-the-counter (OTC) sales.

RESULTS: As a result of the OTC conversion, consumption of nicotine replacement drugs has increased substantially, by 78-92% for nicotine patches and 180% for nicotine gum. It was estimated that the resulting increase in smoking cessation generated annual net social benefits of the order of magnitude of $1.8-2 billion, based on conservative estimates both of the number of quits achieved and the value of added quality-adjusted life years from the reduced smoking.

Keeler, T.E., et al, “The benefits of switching smoking cessation drugs to over-the-counter status.” Health Economics 2002 Jul;11(5):389-402.

Smokeless Tobacco & Bupropion (Zyban)

BACKGROUND: To evaluate the potential efficacy of bupropion sustained release when used in combination with minimal counseling for moist snuff cessation in males. The study was conducted using a double-blind, placebo-controlled 3-month trial. The active treatment group (n = 35) received bupropion SR at 150 mg/day for the first 3 days, then beginning day 4 through day 49 (7 weeks) 150 mg twice a day. The placebo group (n= 35) received 1 tablet every day for 3 days and beginning day 4 through day 49, 1 tablet twice a day.

RESULTS: Bupropion 300 mg/day (150 b.i.d.) produced significantly higher quit rates for smokeless tobacco cessation at the end of treatment (7 weeks) than placebo (p = 0.04). Those using bupriopion were 2.7 times more likely to quit than those using placebo. Bupropion SR appears to be effective for smokeless tobacco cessation.

Glover ED, et al. (2002). A comparison of sustained-release bupropion and placebo for smokeless tobacco cessation. American Journal of Health Behavior, 26(5):386-93.