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NRT and paroxetine for smoking cessation

Institution: Stanford University
Investigator(s): Joel Killen, Ph.D.
Award Cycle: 1997 (Cycle 6) Grant #: 6RT-0041 Award: $646,916
Subject Area: Nicotine Dependence
Award Type: Research Project Awards
Abstracts

Initial Award Abstract
This study has the following specific aim: to compare the effectiveness of a treatment program which combines nicotine patch and antidepressant medication (paroxetine) in helping smokers to stop smoking and to stay quit. We believe that it is important to treat depression symptoms which often occur when people stop smoking because those who experience an increase in depression symptoms are more likely to begin smoking again. The proposed study is very relevant to the TRDRP research priorities concerned with the study of programs which combine approaches for the treatment of nicotine addiction and studies of factors which make it difficult for smokers to stop smoking.

To realize the aim of our proposed study, 300 adult smokers will be assigned at random to one of three treatment groups: (1) nicotine patch + paroxetine given at a dosage of 20mg; (2) nicotine patch + paroxetine given at a dosage of 40mg; (3) nicotine patch + placebo. In addition, all smokers will receive a video which provides helpful stop smoking tips. Study participants will use the nicotine patch and the antidepressant medication for a total of eight weeks. We will evaluate the effectiveness of each of the three treatment groups by determining the extent to which each treatment group helps smokers to stop smoking and remain abstinent. Three months after the conclusion of the treatment program we will ask smokers to visit the study center. Abstinence from smoking will be defined as a report of non-smoking (not even a puff) for seven consecutive days prior to the visit. We will also collect a sample of each smokers' breath and measure the level of carbon monoxide in the breath sample. Smokers have higher carbon monoxide levels than non-smokers. Thus, a measurement of the level of carbon monoxide in a smokers' breath provides a good check on the accuracy of their report of non-smoking. We will also ask participants to visit the study center at 6 and 12 months after the end of the treatment program. Abstinence at 6 and 12 months will be defined as a report of non-smoking (not even a puff) for seven consecutive days prior to contact. We will also measure the level of cotinine in their saliva. When nicotine enters the body it is converted to several products including cotinine. Only smokers have cotinine in their bodies. Thus, cotinine provides an excellent way of determining whether those who say they are not smoking are truly abstinent. We cannot measure cotinine at the three month visit because smokers may still be using nicotine patches.

The proposed study will address several important gaps in our knowledge about how to help smokers stop smoking. First, it will be the first study to examine the effectiveness of a smoking cessation treatment program which combines nicotine patch with antidepressant medication. Second, it will be among the first controlled studies to examine whether antidepressant medication can prevent or reduce depression symptoms which often appear following smoking cessation. Third, in the group of smokers who will receive placebo rather than antidepressant medication, we will determine the extent to which the depression symptoms that are likely to develop following smoking cessation in this group are related to the smokers' ability to stay quit. The study will provide important practical information to the medical and health communities concerning the usefulness of antidepressant medication for smoking cessation and will increase our knowledge of the relationship between nicotine addiction and depression.

Final Report
Smokers (N = 224) were randomized to one of three treatment groups: (1) nicotine patch + placebo; (2) nicotine patch + paroxetine (20mg); (3) nicotine patch + paroxetine (40mg). Assignment to treatment was double blind. Patch treatment was provided for 8 weeks; paroxetine or placebo was provided for 9 weeks. Abstinence rates at weeks 4, 10 & 26 were as follows: (1) nicotine patch + placebo: 45%,36% & 25%; (2) nicotine patch + paroxetine (20mg): 48%,33% & 21%, (3) nicotine patch + paroxetine (40mg): 57%, 39% & 27%. The differences were not statistically significant. The combined treatment was more effective than nicotine replacement alone in reducing both craving and depression symptoms associated with smoking cessation. A sub-group analysis comparing participants who were compliant with the protocol was also conducted. Abstinence rates at weeks 4, 10 & 26 were as follows: (1) nicotine patch + placebo: 46%, 35% & 24%; (2) nicotine patch + paroxetine (20mg): 64%, 43% & 33%; (3) nicotine patch + paroxetine (40mg): 74%, 51% & 38%. The differences between paroxetine groups and placebo at week 4 were statistically significant. Although the overall results of this study are negative, paroxetine may add value to the current standard of care in excess of potential risk. However, more conclusive evidence is needed.
Publications

Nicotine replacement therapy and paroxetine for smoking cessation
Periodical: Journal of Consulting and Clinical Psychology Index Medicus:
Authors: Killen JD, Fortmann SP, Schatzberg AF, et al ART
Yr: 0 Vol: Nbr: Abs: Pg:

Nicotine patch and paroxetine for smoking cessation
Periodical: Journal of Consulting and Clinical Psychology Index Medicus:
Authors: Killen JD, Fortmann SP, Schatzberg AF, et al ART
Yr: 2000 Vol: 68 Nbr: 5 Abs: Pg: 883-889

Onset of major depression during treatment for nicotine dependence
Periodical: Addictive Behaviors Index Medicus:
Authors: Killen JD, Fortmann SP, Schatzberg AF, Hayward C, Varady A ART
Yr: 0 Vol: Nbr: Abs: Pg: