Penny N. Glover

Efficacy of the nicotine inhaler in smoking reduction: A double-blind, randomized trial

Many smokers are not ready to quit but are interested in changing their smoking behavior, particularly if such a change is associated with a reduction in health risk. The present study evaluated the efficacy of the nicotine inhaler in reducing smoking. Exploratory studies assessed whether reduction in smoking was associated with reduction in markers of disease risk. A total of 429 healthy smokers (smoking at least 20 cigarettes/day) were randomly assigned to either nicotine-containing or placebo inhalers, which subjects were allowed to use ad libitum for up to 1 year. The nicotine inhaler was significantly superior to placebo in achieving reduction in daily cigarette consumption by at least 50% after 4 months, compared with baseline (18% vs. 8%, p = .004). Active treatment promoted smoking cessation: 8% of subjects in the nicotine group and 1% in the placebo group were abstinent at month 15. Throughout the study, smoking reduction, per se, independent of treatment group, was associated with a statistically significant decrease in exhaled carbon monoxide and serum cotinine and thiocyanate. Smoking reduction also improved established risk markers for cardiovascular disease over 4 months. The incidence of adverse events did not differ significantly between the active and placebo groups. The most common treatment-related adverse events were throat irritation and cough. In conclusion, the nicotine inhaler can help smokers who are unable or unwilling to quit to reduce daily cigarette consumption, which may be a health benefit on its own and may further promote quitting.

A comparison of a nicotine sublingual tablet and placebo for smoking cessation

This study assessed the efficacy and safety of a nicotine sublingual tablet in smoking cessation in a randomized, double-blind, placebo-controlled outpatient trial conducted between January 1996 and May 1997. Two hundred and forty-one adult smokers (> or = 10 cigarettes/day for at least 3 years) used nicotine 2-mg sublingual tablet (n = 120) or placebo (n = 121) for up to 6 months (a 3-month treatment period followed by a 3-month tapering period). Subjects who scored <7 on the Fagerström Tolerance Questionnaire used 1 tablet/h (up to maximum of 20/day), whereas subjects who scored (7 used 2 tablets/h (up to maximum of 40/day). Brief counseling was provided at baseline and at all visits. Self-reported abstinence was measured from week 2 onwards, confirmed by expired carbon monoxide (CO) levels <10 ppm at each visit (1, 2, 3 and 6 weeks and 3, 6 and 12 months). After 6 weeks of treatment, CO-validated abstinence rates were 48% in the active group and 23% in the placebo group (p < 0.0001). At the 3-, 6- and 12-month visits, abstinence rates (active vs. placebo) were 33% vs. 17% (p = 0.0046), 21% vs. 11% (p = 0.0304) and 18% vs. 10% (p = 0.0606). Adverse events were mild and transient and reflected those reported with existing nicotine replacement formulations. We concluded that the nicotine 2-mg sublingual tablet was effective as a smoking cessation aid.

A comparison of sustained-release bupropion and placebo for smokeless tobacco cessation.

OBJECTIVE To evaluate the potential efficacy of bupropion sustained release when used in combination with minimal counseling for moist snuff cessation in males. METHODS A double-blind, placebo-controlled 3-month trial. The active treatment group (n = 35) received bupropion SR at 150 mg/qd day for the first 3 days, then beginning day 4 through day 49 (7 weeks) 150 mg/ b.i.d. The placebo group (n= 35) received 1 tablet qd for 3 days and beginning day 4 through day 49, 1 tablet/b.i.d. 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) with an OR of 2.73. CONCLUSION Bupropion SR appears to be effective for smokeless tobacco cessation.

Treating Nicotine Dependence

This article reviews the biology of nicotine addiction and the most effective treatments for nicotine dependence. Nicotine elevates dopamine levels in the brain, which is associated with drug reinforcement and dependence. Nicotine abuse leads to nicotine dependence. The most effective pharmacological adjuncts for treating nicotine dependence are nicotine replacement therapy and bupropion SR. When these are combined with behavioral counseling, the best treatment outcomes are observed.

A multicenter phase 3 trial of lobeline sulfate for smoking cessation.

OBJECTIVE To evaluate the safety and efficacy of sublingual lobeline sulfate for smoking cessation. METHODS A multicenter (3 sites), double-blind, parallel, placebo-controlled, phase 3 smoking cessation trial of sublingual formulation of lobeline sulfate. A total of 750 smokers (250 per site) were randomized to either treatment (lobeline sulfate) or placebo with individual smoking cessation counseling lasting up to approximately 10 minutes. RESULTS Efficacy revealed no statistical significance (P = 0.62) for lobeline sulfate as a smoking cessation aid. CONCLUSION Sublingual formulation of lobeline sulfate does not appear to be an effective smoking cessation aid.

Pharmacologic treatments for the nicotine dependent smoker.

OBJECTIVE To explore the biology of nicotine addiction and to investigate the latest pharmacological treatments for nicotine dependence. METHODS Explore the research literature for treating nicotine dependence. RESULTS Nicotine is an additive drug and the most effective methods for treating dependence are nicotine replacement therapy (NRT) and bupropion SR. CONCLUSION The best available treatments for nicotine dependence are pharmacological adjuncts; specifically, NRT and bupropion SR when combined with behavioral counseling.

The Conflict of Tobacco Education Among American Indians: Traditional Practice or Health Risk?

Tobacco has always been and continues to be an integral part of Native American religions. Tobacco provides Indian people a connection between their own culture and the spirit world. The practice of using tobacco is very honorable in religious beliefs of a tribe and has been associated with peace and healing among American Indians (AIs) for generations. Tobacco is used as an offering, as a medicine, for prayer, or a sacrament. Tobacco use during prayer or ceremony may be smoked (inhaled or not inhaled), used in a pipe or in the form of a cigarette, placed in the fire, placed on a drum, given as a gift, or used to contact the spirit world.1

Sensitivity and specificity of a reagent-impregnated test strip in identifying smokeless tobacco users.

This study was designed to determine the sensitivity and specificity of a reagent-impregnated test strip in identifying habitual snuff users and tobacco chewers. Urine specimens were obtained from smokeless tobacco users and controls and blind tested on-site using a reagent-impregnated test strip. Samples also were sent to our university hospital lab for cotinine and nicotine analysis by gas chromatography (GC). The test strip results were compared with GC results and self-reported use of snuff and chewing tobacco. A total of 61 subjects enrolled in the study: 26 snuff users, 25 tobacco chewers, and 10 nonconsumers of nicotine. Using GC assessment of nicotine and cotinine (>or=200 ng/ml) as the standard, we found the sensitivity of the test strip to be 96% (25/26) for snuff users and 96% (24/25) for tobacco chewers. When compared with self-report, the sensitivity of the test strip was 92.3% (24/26) for snuff users and 84% (21/25) for tobacco chewers. The specificity for nonusers of nicotine was 100% (10/10) for both the self-report and GC conditions. These results suggest that a reagent-impregnated test strip is a rapid, valid, and user-friendly means of differentiating smokeless tobacco users from nonconsumers of tobacco. The intensity of the pink color on the test strip is proportional to the amount of nicotine or its metabolites present in urine and therefore offers a semiquantitative measure of nicotine consumption.