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Effectiveness of two different regimens in smoking clinic

Institution: University of California, Los Angeles
Investigator(s): Scott Eliot Sherman, M.D., M.P.H.
Award Cycle: 1999 (Cycle 8) Grant #: 8RT-0068 Award: $272,989
Subject Area: Nicotine Dependence
Award Type: Research Project Awards

Initial Award Abstract
Smoking is the number one cause of death in the United States that can be prevented. It is responsible for one out of every five deaths. Illnesses that are can be due to smoking include heart disease, cancer, and lung diseases such as chronic obstructive pulmonary disease, all of which are very expensive to treat. Many efforts have been aimed to try to decrease the amount of people who smoke, but 20-30% of Americans continue to smoke.

In order to increase the number of individuals who do not smoke, the Sepulveda Veterans Administration Medical Center (VAMC) began using bupropion as part of its Smoking Cessation Clinic (SCC). Bupropion is new medication that has been shown to help people quit smoking. The SCC is a two-month program that uses counseling and nicotine patches to help people who are trying to stop smoking. Many studies have looked at how useful bupropion is at helping people quit when it is used in combination with counseling and nicotine patches. However, most of these studies occur under very strict conditions and their results may not be appropriate to all populations. Also, these studies may not answer questions about how effective or how successful bupropion is when it is used in normal clinical conditions.

In order to evaluate the success of smoking cessation medicines in routine practice, this study would examine the effectiveness of bupropion and the combination of bupropion plus nicotine patches in the SCC. We currently receive 50-60 new patients per month. Patients attending the clinic receive one-on-one counseling in a group setting. A pharmacist assigns medicine (nicotine patch and/or bupropion) before starting the clinic based on information provided by the patient. If no restrictions are found for taking any of the medicines, a person will randomly be assigned to a medicine group. The effectiveness of the two medicine groups will be determined by looking at the number of people who complete the SCC, the number who remain non-smokers six months after finishing the program, and the cost of each medicine. Also, the number and types of side effects caused by the medicine and any changes in what medicine was taken during the program will be assessed in order to determine how well patients tolerated the medicine. We will also determine the number of patients who were able to be assigned to a medicine group out of everyone who enrolled in the program. Significant differences in the success of each medicine group, based on the number of people who remain non-smokers six months after the program, will become an important factor in setting up a standard plan that is more likely to help patients quit smoking.

In the US, about 50 million people still smoke. This shows that an effective and economic program is needed to help people quit smoking. Finding an effective medicine plan can help decrease the amount of disease, disability, and death that is due to smoking cigarettes. This study would help determine which of these two regimens is the most effective way to help people stop smoking in a clinical setting.

Final Report
Many studies have been conducted on the efficacy of different smoking cessation therapies in controlled trials. However, few studies have looked at their effectiveness in everyday clinical practice. This study is an analysis of the effectiveness of bupropion versus bupropion plus nicotine patch in a routine clinical setting at the Sepulveda VA’s Smoking Cessation Clinic (SCC). Our primary goals were to compare the two treatment regimens with respect to the percent of patients able to take the medications, side effects, completion rates of the SCC, six-month abstinence rates, and cost.

This study took place February 25, 2000 through June 29, 2001. During this time, all patients enrolled in the SCC were asked to participate in the study. Consenting patients had the option of agreeing to one or more of the following study components: 1) random assignment to receive bupropion or bupropion plus nicotine patch, 2) complete the baseline and follow-up survey, and 3) give access to their medical records. Of the 708 patient referrals received by the SCC, 388 (55%) attended at least one session of the eight-week long program. Of these, 89% were eligible to receive either of the two treatment regimens. 274 (71%) consented to participate in one or more parts of the study, but only 174 agreed to be randomized to a treatment. Of these, 82 were randomly assigned to the bupropion treatment group and 92 were randomly assigned to the combination group (bupropion plus nicotine patch).

Side effects were reported by 37/67 (55%) of people taking bupropion and 57/81 (70%) of people taking combination therapy (p=0.05). The most commonly reported side effects were dry mouth (8%), insomnia (4%), and constipation (2%). Treatment regimens were changed in 7% of patients that started on bupropion and 14% of patients that started on combination therapy (p value not significant). Changes in therapy were due mainly to intolerable side effects and patient request for a different medication.

Two-month smoking abstinence was based upon patient self-report and verified by carbon monoxide testing. Among the 174 study patients who were randomly assigned to treatment, 120/174 (69%) successfully completed the 2-month program. The rate of completion was slightly higher among the combination therapy group (38% vs. 27%) although it did not quite reach statistical significance (p=0.1).

Six-month smoking abstinence rates were assessed using follow-up telephone interviews. Based on the self-report of the 117 patients who were randomly assigned to treatment and completed the follow-up interviews, 22/52 (42%) of patients who used bupropion and 23/65 (35%) of patients who used combination therapy were abstinent at 6 months. Abstinence was defined as not having smoking at all in the last 30 days prior to the follow-up interview. However, these results were not statistically significant (p=0.4)

Our results indicate that combination therapy may be superior to bupropion alone at 2 months but there was no difference in 6-month abstinence rates. However, sample size limitations may have contributed to our inability to find a long term difference.