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Transdermal nicotine replacement for hospitalized smokers

Institution: University of California, San Francisco
Investigator(s): Joel Simon, M.D., M.P.H.
Award Cycle: 1997 (Cycle 6) Grant #: 6RT-0002 Award: $451,969
Subject Area: Nicotine Dependence
Award Type: Research Project Awards
Abstracts

Initial Award Abstract
The US Surgeon General has identified smoking as the single largest cause of premature loss of life in the United States. It has been estimated that more than 400,000 deaths occur each year in this country as a result of tobacco use. Recent data indicate that approximately one in four America are current smokers. Because of the large disease burden associated with cigarette smoking, decreasing the percentage of Americans who smoke is an important public health goal.

There are at least 6.5 million adult smokers hospitalized yearly in the US, providing doctors and health educators a window of opportunity to reach smokers with smoking cessation inter-ventions. Patients are often hospitalized for a smoking-related illness, may not be able to smoke while hospitalized because of restrictive smoking policies, and may, therefore, be more open to quitting smoking. To date, relatively few controlled clinical trials have examined whether hospital-based smoking cessation interventions are effective in helping smokers quit.

The Smoking Cessation Research Group at the San Francisco VA Medical Center recently completed one of the largest hospital-based smoking cessation clinical trials. A total of 324 smokers received intensive counseling or minimal counseling during hospitalization for noncardiac surgery. Participants in the intensive intervention group also had the option to receive nicotine replacement therapy on an out-patient basis. The results of this study, which have been accepted for publication. In the Archives of Internal Medicine, demonstrated that such a behavioral modification intervention could double the rate of smoking cessation compared with a minimal counseling intervention.

Because the effectiveness of the nicotine patch for in-patient smoking cessation has not been studied previously, we propose a clinical trial In which all study participants will receive the nicotine patch during their hospitalization. Use of the nicotine patch will continue for 2 months. In addition, participants will be randomly assigned to receive either intensive counseling or minimal counseling. If minimal counseling and the nicotine patch results in a quit rate that is similar to that achieved by intensive counseling and the nicotine patch, we would recommend that hospitalized smokers who want to quit smoking receive the patch and the less intensive intervention first, reserving the more intensive counseling for out-patient smokers who require more individualized attention.

Although 40 million Americans have quit smoking, approximately 50 million continue to smoke. Effective, economical, targeted smoking cessation and relapse prevention programs that are capable of reaching millions of American smokers who are hospitalized each year have the potential to decrease the burden of disease, disability, and death resulting from tobacco use. The effectiveness of the nicotine patch combined with counseling when used in hospital-based programs needs to be evaluated to define the role of the patch in this setting. The proposed study would be an important contribution to this relatively understudied area of smoking cessation research.

Final Report
There are at least 6.5 million adult smokers hospitalized yearly in the US, providing a window of opportunity to reach smokers who want to quit. To date, relatively few controlled clinical trials have examined whether hospital-based smoking cessation interventions are effective. We conducted a clinical trial in which all study participants received the nicotine patch during their hospitalization, the use of which continued for 2 months. In addition, participants were randomly assigned to receive either intensive or minimal counseling. If minimal counseling and the nicotine patch resulted in a similar quit rate to that achieved by intensive counseling and the nicotine patch, we would have recommended that hospitalized smokers who want to quit smoking receive the patch and the less intensive intervention first, reserving the more intensive counseling for out-patient smokers who require individualized attention.

We enrolled 223 participants and have 6-month follow-up data on 219 participants: 107 intervention and 105 comparison subjects. At 6-months, 7 participants had died and 4 participants were lost-to-follow-up. By self-report at 6-months, 35% of the intensive counseling + nicotine patch participants have quit compared with 21% of the minimal counseling + nicotine patch participants (P = 0.03). Almost complete data are available for the one-year follow-up. Follow-up at one-year is complete for 217 of the 223 enrolled participants. By self-report at one year, 34% of the intensive counseling + nicotine patch participants have quit compared with 21% of the minimal counseling + nicotine patch participants (P = 0.05). To date, the biochemically- or proxy-confirmed quit rate is 28% among the intensive counseling + nicotine patch participants compared with 17% among the minimal counseling + nicotine patch participants (P = 0.05). At 12 months, there were 5 deaths in the intervention group and 9 deaths in the comparison group (P = 0.34). A total of 6 (or 3%) of participants were lost to follow-up and were considered smokers for the analyses.

Effective, economical, targeted smoking cessation and relapse prevention programs that are capable of reaching millions of American smokers who are hospitalized each year have the potential to decrease the burden of disease, disability, and death resulting from tobacco use. Hospital-based intensive counseling and follow-up + the nicotine patch is more effective than hospital-based minimal counseling + the nicotine patch in increasing 6-month and one-year quit rates. Because hospitalization presents a unique window of opportunity to reach smokers who may want to quit, we believe that the necessary resources should be found to fund clinically-proven intensive hospital-based smoking cessation interventions.
Publications

Smoking cessation after surgery: a randomized trial
Periodical: Proceedings of the TRDRP Annual Investigator's Meeting Index Medicus:
Authors: Simon JA, Solkowitz SN, Carmody TP, Browner WS ABS
Yr: 1997 Vol: Nbr: Abs: 6D,page 27 Pg:

Transdermal nicotine replacement for hospitalized smokers: a randomized trial
Periodical: Proceedings of the TRDRP Annual Investigator's Meeting Index Medicus:
Authors: Simon JA, Carmody TP, Snyder E, Tcheou YM, Murray J ABS
Yr: 1998 Vol: Nbr: 3I Abs: Pg: 22

Transdermal nicotine replacement for hospitalized smokers: a randomized trial
Periodical: Proceedings of the TRDRP Annual Investigator's Meeting Index Medicus:
Authors: Simon JA, Carmody TP, Snyder E, Murray J, Solkowitz S ABS
Yr: 1999 Vol: Nbr: E15 Abs: Pg: 47

Bupropion for smoking cessation: a randomized trial
Periodical: Proceedings of the TRDRP Annual Investigator's Meeting Index Medicus:
Authors: Simon JA, Carmody TP, Duncan C, Snyder E ABS
Yr: 1999 Vol: Nbr: E16 Abs: Pg: 48