Serum nicotine and cotinine levels during nicotine-patch therapy.

We related serum nicotine and cotinine levels while subjects were smoking their usual numbers of cigarettes to levels while wearing a nicotine patch under carefully controlled, smoke-free conditions in a clinical research center. Twenty-four volunteers who needed intensive treatment for severe nicotine dependence were admitted to the clinical research center and were treated with a 22 mg transdermal nicotine patch each day and an intensive smoking-cessation program. Serum nicotine and cotinine levels, withdrawal symptoms, and hours and quality of sleep were noted. The steady-state serum nicotine and cotinine levels produced with the nicotine patch were lower than those observed when the subjects were smoking. Mean nicotine and cotinine levels were inversely related to mean withdrawal scores for the first 6 days. A fixed dose of transdermal nicotine will not be effective for all smokers. Individualization of therapy should be based on objective biologic measures such as serum cotinine and subjective assessment of withdrawal relief.

Nicotine-replacement therapy with use of a transdermal nicotine patch--a randomized double-blind placebo-controlled trial.

The rate of smoking was significantly reduced in volunteer subjects by providing effective nicotine replacement, self-help material, and weekly visits with a nurse for 6 weeks. Nicotine-replacement therapy with a transdermal nicotine patch (Nicolan) almost doubled the 6-week smoking-cessation rate in comparison with that in a placebo group (77% versus 39%; P = 0.002) among subjects who were smoking at least 20 cigarettes per day at baseline. Although most subjects who used the active nicotine patches had skin reactions, the reactions were primarily mild. For use of both active and placebo patches, the level of patient compliance was high. Among subjects who continued to smoke, the use of cigarettes was decreased to less than 50% of the baseline smoking level in 7 of 7 with active nicotine patches and in 15 of 19 with placebo patches. Outcomes beyond 6 weeks showed a substantial relapse rate in both groups. Thus, when nicotine-replacement therapy is provided, a need exists for concurrent behavioral intervention and training for prevention of a relapse, neither of which was part of this protocol.

Cessation of long-term nicotine gum use--a prospective, randomized trial.

Nicotine gum is an important adjunct for smoking cessation for many smokers, and long-term use of nicotine gum will occur in a small percentage of patients. To date, no method of cessation in long-term users has been studied in a randomized trial. We enrolled 26 subjects at the Mayo Clinic site of the Lung Health Study who had used nicotine gum for more than 6 months to participate in a trial where subjects were randomly assigned to: (1) abrupt cessation, (2) taper with placebo gum, or (3) taper with active gum. At the end of the 6-week trial, the percentage of subjects abstinent from gum use and not smoking was not different among the three groups: 66.7% for the abrupt cessation group, 71.4% for the taper with placebo gum group and 60% for the taper with active gum group. One subject in the taper with placebo gum group relapsed to smoking during the trial but was abstinent from smoking again at long-term follow-up. Long-term follow-up (median 284 days) showed 65% of subjects were abstinent from all nicotine products. Motivated subjects can stop long-term nicotine gum use without relapse to gum use or smoking by either abrupt cessation or brief tapering.

A comprehensive model for the treatment of nicotine dependence in a medical setting.

We have summarized the basic components of a comprehensive model for the treatment of nicotine addiction in a medical setting. It is a labor-intensive program with emphasis on individual assessment and the development of individual treatment programs adaptable to all levels of nicotine dependence. We anticipate that this model will be increasingly used by medical centers in the future. As more traditional programs successfully treat the less severely nicotine-dependent patients, more severely dependent smokers are left in need of more intensive services. We have already begun to see this trend in our practice, requiring more counselor time for individual follow-up and referral into our group therapy programs. Adjunctive pharmacologic therapy is an exciting and promising area, but best results include associated behavioral intervention. Reimbursement remains a major impediment to patient involvement in many of these programs. This impediment will be overcome when third-party payers begin to cover these services as endorsed by the Surgeon General and the United States Department of Health and Human Services.

Error in smoking measures: effects of intervention on relations of cotinine and carbon monoxide to self-reported smoking. The Lung Health Study Research Group.

OBJECTIVES: Sources of measurement error in assessing smoking status are examined. METHODS: The Lung Health Study, a randomized trial in 10 clinical centers, includes 3923 participants in a smoking cessation program and 1964 usual care participants. Smoking at first annual follow-up was assessed by salivary cotinine, expired air carbon monoxide, and self-report. Each of these measures is known to contain some error. Sensitivity and specificity were calculated by comparing a biochemical measure with self-report to produce an undifferentiated estimate of error. Classification error rates due to imprecision of the biochemical measures and to the error in self-report were estimated separately. RESULTS: For cotinine compared with self-report, the sensitivity was 99.0% and the specificity 91.5%. For carbon monoxide compared with self-report, the sensitivity was 93.7% and the specificity 87.2%. The classification error attributed to self-report, estimated by comparing the results from intervention and control groups, was associated with the responses of 3% and 5% of participants, indicating a small but significant bias toward a socially desirable response. CONCLUSIONS: In absolute terms in these data, both types of error were small.

Self-administered Nicotine-Dependence Scale (SANDS): item selection, reliability estimation, and initial validation.

The Self-Administered Nicotine-Dependence Scale (SANDS) is a questionnaire to assist in the determination of the most appropriate intervention for the nicotine-dependent individual. Six content domains included are: (1) self-efficacy; (2) social skills deficit; (3) loss of control; (4) consequences of use; (5) social support for smoking; and (6) concern for healthy life-style. A preliminary set of 79 items was reduced to a 32-item scale, which, in turn, was divided into two non-overlapping subscales of 16 items each. Logistic regression analyses of an additional sample of subjects indicated that the SANDS added predictive power to knowledge of sex and transdermal-patch status for predictions of smoking status 6 months later.

An integrated approach to the treatment of nicotine dependence in a medical center setting: description of the initial experience.

A nicotine-dependence treatment program can be implemented in a medical center setting by using a model that involves physician, patient, and nicotine-dependence counselor. The physician-referred and counselor-directed consultations are followed by a systematic relapse-prevention program. The counselors utilize behavioral approaches, the philosophy and principles of the addictive disorders field, and adjunctive pharmacologic therapy. The patients are chronic, heavy smokers who have had many previous quit attempts and are highly nicotine-dependent. Important factors include: 1) referral by physicians, 2) physicians' active role in the intervention, 3) expertise of the counselors, 4) structured relapse-prevention program, and 5) provision of services in a smoke-free medical center.

Nicotine patch therapy for smoking cessation combined with physician advice and nurse follow-up. One-year outcome and percentage of nicotine replacement.

OBJECTIVE: To determine the efficacy of a 22-mg nicotine patch combined with the National Cancer Institute program for physician advice and nurse follow-up in providing withdrawal symptom relief, 1-year smoking cessation outcome, and percentage of nicotine replacement. DESIGN: Randomized, double-blind, placebo-controlled trial. SUBJECTS: Two-hundred forty healthy volunteers who were smoking at least 20 cigarettes per day. INTERVENTIONS: Based on the National Cancer Institute program, subjects received smoking cessation advice from a physician. Follow-up and relapse prevention were provided by a study nurse during individual counseling sessions. Subjects were randomly assigned to 8 weeks of a 22-mg nicotine or placebo patch. MAIN OUTCOME MEASURES: Abstinence from smoking was verified by expired air carbon monoxide levels. Withdrawal symptoms were recorded during patch therapy, and the percentage of nicotine replacement was calculated by dividing serum nicotine and cotinine levels at week 8 of patch therapy by levels obtained while smoking. RESULTS: Higher smoking cessation rates were observed in the active nicotine patch group at 8 weeks (46.7% vs 20%) (P < .001) and at 1 year (27.5% vs 14.2%) (P = .011). Higher smoking cessation rates were also observed in subjects assigned to the active patch who had lower serum levels of nicotine and cotinine at baseline, and withdrawal symptom relief was better in the active patch group compared with placebo. CONCLUSIONS: Clinically significant smoking cessation can be achieved using nicotine patch therapy combined with physician intervention, nurse counseling, follow-up, and relapse prevention. Smokers with lower baseline nicotine and cotinine levels had better cessation rates, which provides indirect evidence that they had more adequate nicotine replacement with this fixed dose of transdermal nicotine than those smokers with higher baseline levels.