General psychiatry and psychotherapy with outpatient clinic

The implementation of smoking cessation groups facilitates the motivation for abstinence in patients with tobacco-related health problems. For this reason, the aim of our first study was to introduce smoking cessation programmes in general medical and internal medicine practices.

Since the implementation of smoking cessation groups is personnel- and time-intensive and thus associated with not inconsiderable costs, a self-help manual, also referred to as "bibliotherapy", was used as an alternative to behavioral group therapy. Self-help manuals reach a large number of smokers who are willing to give up smoking and, because they are easy to use, they can be integrated into the medical practice without great effort.

Therefore, one task of the first project was the development and use of a self-help manual in order to examine the efficiency of such a manual in comparison with conventional behavioural therapy group therapy.

Finally, we investigated the significance of long-term nicotine patch administration during the critical relapse period (six months after completion of cessation treatment). It remained to be seen whether this would provide decisive protection against relapse.

Decisive for the evaluation of the success of a therapy method in the field of smoking cessation are the long-term abstinence rates. It was shown that both methods are comparable with regard to their prospects of success.

Prospects of success depending on therapy condition (group therapy and bibliotherapy) after the end of therapy (T0), after one month (T1), after 6 months (T6) and after one year.

In our study, abstinence rates for behavioral group therapy were 22% one year after the end of treatment, and 19% for bibliotherapy, which can be considered a good result given the strong average dependence of the participants; the success rates for bibliotherapy are even in the upper range of expected results.

When participants were interviewed, the group session, keeping a tally sheet to monitor cigarette use, and gradually reducing cigarette use were found to be positive.

Furthermore, the results indicate that a gradual reduction in cigarette consumption is perceived as facilitating the cessation process and thus represents an important alternative to immediate smoking cessation.

The analysis of relapse course and causes showed that the critical phase for relapses is one or three months after the end of treatment. After this time, only a small percentage of participants relapsed. Stressful situations and mental tension were cited as the most significant reasons for relapse.

The majority of participants rated the nicotine patch as helpful in the withdrawal process and used it regularly. The importance of the nicotine patch is particularly evident in the fact that the longer the patch was used, the greater the treatment success.

The treatment success was also determined by the initial motivation as well as the degree of nicotine dependence.

Particular risk groups are additionally endangered by smoking. These include, for example, patients with vascular diseases, smokers with particularly strong physical dependence, pregnant women or women with an unfulfilled desire to have children. The success of smoking cessation treatments is particularly important in these groups.

However, current smoking cessation treatments are aimed at smokers in general, without acknowledging specific risk factors in detail.

For this reason, we are working to adapt existing smoking cessation treatments to the concerns of these groups in order to increase success rates.

According to epidemiological studies, only about 50% of pregnant women succeed in giving up smoking during pregnancy, while 25% reduce their cigarette consumption or continue smoking unchanged. Pregnant women, as well as women with an unfulfilled desire to have children, women taking the pill or women with other gynaecological diseases are urgently advised to stop smoking.

Prospects of success after one year depending on therapy and risk condition. Women with risk factor benefit most from individual therapy, healthy smokers benefit equally from individual and group therapy. In the control groups, an informational interview was conducted with each of the study participants.

For this reason, treatment programmes for women belonging to one of the above-mentioned risk groups were developed and tested for their effectiveness in a further, completed study. The usual standard treatment is enriched with additional information, motivational aids, greater consideration of social support, information on nutrition and sporting balance, as well as components for stabilising abstinence. In the context of this study, the combination of the behavioural therapy withdrawal method with nicotine substitution was deliberately avoided.

A total of 257 women participated in the study. The results show that the chances of success of smoking cessation therapy can be significantly improved by a "modified treatment". Women with risk factors benefit most from individual treatment (long-term probability of success: 40%), whereas women without risk factors benefit from both group and individual treatment (long-term probability of abstinence: 34%).

Reference: Batra, A., Schupp, P.E., & Buchkremer, G. (1999). Tobacco cessation in pregnant women or smokers with health risk factors. Addiction, 45, 339-345.

Heavily dependent smokers hardly benefit from the existing possibilities of smoking cessation and are regarded as a risk group among smokers with a high health risk. This suggests that - in the course of efforts to develop risk group-specific therapies - treatment programmes already introduced should be optimised by placing greater emphasis on nicotine substitution for the treatment of nicotine dependence.

In this study, heavily dependent smokers received nicotine patch treatment as part of a six-week behavioral treatment program and were also expected to use nicotine nasal spray in addition, depending on subjective perceived need. 60 smokers participated in the study. After six months, 48% of the participants were still abstinent, after one year 31%. Thus, it could be shown that a stronger consideration of nicotine dependence can lead to significantly higher medium-term, but also long-term abstinence rates.

Short-, medium- and long-term success rates of heavy smokers as a function of treatment condition. One group (44 subjects) was treated with patch, the other group (60 subjects) was treated with patch + nicotine nasal spray). Heavy smokers particularly benefit from treatment with nicotine patch + nicotine nasal spray.

References:

Batra, A., Schupp, P.E., & Buchkremer, G. (1998). The treatment of severely dependent smokers with nicotine patches and nicotine nasal spray. In: K.O. Haustein (Ed.) Smoking and nicotine - Current contributions to smoking cessation. Nuremberg: Perfusion. S. 59-68.

Batra, A., Schupp, P.E., & Buchkremer, G. (1999). Combined use of nicotine replacement products in highly dependent smokers - effectiveness of nasal spray and patch. Nicotine and Tobacco Research, 1, 188 -189.

Compared with the general population, the risk of becoming a smoker is significantly increased in psychiatric patients. At the Psychiatric University Hospital in Tübingen, 368 patients with schizophrenic, depressive and substance-induced (alcoholism and drug dependence) disorders were examined with regard to their smoking behaviour.

Of the 368 patients examined, 56.3% described themselves as smokers, 8.2% as ex-smokers and 35.5% as non-smokers.

Compared with the general population, there were the highest number of smokers among drug-dependent (90.5%) and alcohol-dependent (75.3%) patients. In the group of patients with schizophrenic disorders 63.5% and patients with depressive disorders 32.4% were smokers.

The most pronounced nicotine dependence was shown by drug addicts (5.8 points in the Fagerström test), followed by alcoholics and patients with schizophrenic or depressive disorders (4.7 - 4.9 points in the Fagerström test). The FTND score of the general population is estimated at 3.6.

Bupropion

In July 2000, the smoking cessation drug bupropion (Zymbalta) was approved in Germany. The presumed effect of the substance is based on a regulation of messenger substances in the brain, which can lead to a significant reduction in the desire to smoke.

Studies on the efficacy of the drug in comparison with other forms of therapy are already available from the USA and England, where this drug has been approved for smoking cessation since 1997.

In 1999-2000, the Smoking Cessation Working Group of the University Hospital of Tübingen participated in a Europe-wide study on the efficacy of bupropion.

In this double-blind study, the study participants were recruited exclusively from medical staff (physicians, nurses). They received either the drug bupropion or a placebo during a treatment phase of seven weeks. The abstinence rates of the study participants were recorded at the end of treatment and after one year.

"Harm reduction" - smoking reduction as a treatment strategy

The only moderate abstinence success of smoking cessation treatment in recent years, as well as the limited effect of preventive measures, led to the search for alternative concepts in combating the problem. With regard to the reduction of health damage associated with smoking, ways of successfully reducing smoking are being sought.

Two further clinical trials were designed to investigate the efficacy of nicotine gum for the purpose of reducing smoking and promoting smoking cessation, as well as the tolerability of using nicotine gum in the presence of continued cigarette use. 214 participants were included in the study and randomly assigned to one of two treatment groups (short-term vs. long-term smoking reduction strategy). In the short-term smoking reduction group, smoking reduction was to be achieved by using the gum for 4 weeks, and then smoking cessation was to be attempted. In the long-term smoking reduction treatment group, study participants could reduce cigarette consumption with the aid of the chewing gum, over a period of 6-9 months, and then also attempt smoking cessation. The participants were given either nicotine gum or chewing gum without an active ingredient (placebo) to accompany the smoking reduction. Successful smoking reduction was defined as a 50% decrease in daily cigarette consumption measured against daily cigarette consumption at baseline. In both studies, nicotine gum was found to be superior to placebo for smoking reduction. Abstinence rates at one year were low, but slightly higher in the groups using nicotine replacement. Simultaneous use of nicotine gum and continued cigarette smoking was found to be well tolerated.

Reference: Batra, A., Klingler, K., Landfeldt, B., Friederich, H.M., Westin, A., & Danielsson, T. (2005). Smoking reduction treatment with 4-mg nicotine gum: a double-blind, randomized, placebo-controlled study. Clinical Pharmacology and Therapeutics, 78(6), 689-96.

With funding from the Federal Ministry of Education and Research, a scientific study on the biological and psychological basis of tobacco dependence was conducted in the period 2002-2004. All smokers treated underwent a six-week standard smoking cessation programme oriented towards behavioural therapy. The standard smoking cessation program also included a recommendation for concomitant medication to support tobacco cessation. However, study participants were free to follow this recommendation.

It was suspected that certain 'smoker types' could be distinguished among those smokers willing to quit. Based on a broad survey of psychological variables, four smoker profiles were identified: subclinically 'depressed', 'hyperactive' and 'highly dependent' smokers, and a group of smokers with 'inconspicuous' profiles.

The results of the study showed that those smokers who had elevated scores on scales that captured various psychological variables or physical nicotine dependence, and thus belonged to one of the 'conspicuous' smoking profiles were more likely to smoke one year after treatment than smokers with an 'inconspicuous' smoking profile. Those smokers who could be assigned to one of the 'conspicuous' smoking profiles had poorer odds of becoming and remaining abstinent. The corresponding smoker profiles 'depressed', 'hyperactive', 'highly dependent' could be labelled and grouped as 'risk profiles'. It was reasonable to assume that smokers with 'risk profiles' would benefit more from smoking cessation treatment tailored to their needs. This assumption was to be tested in the subsequent study.

Publications:

Batra, A., Collins, S.E., Torchalla, I., Schröter, M., & Buchkremer, G. (2008). Multidimensional smoker profiles and their prediction of smoking following a pharmacobehavioral intervention. Journal of Substance Abuse Treatment, 35 (1), 41-52.

Collins, S.E., Torchalla, I., Schröter, M., Buchkremer, G., & Batra, A. (2008). Development and validation of a cluster-based classification system to facilitate treatment tailoring. International Journal of Methods in Psychiatric Research, 17, Suppl.1, 65-69.

A further intervention study was designed in which the results of the previous study were to be examined to see whether they could be replicated and in which, in addition, modified - i.e. adapted to the needs of the different types of smokers - treatment strategies (modT) were to be developed and tested to see whether smokers with a 'risk profile' benefit more from them than from treatment with standard therapy (ST).

A total of 268 smokers were included in this study.

The results showed, firstly, that the smoking profiles identified in the previous study could be replicated in this new sample of smokers. They continued to show good abstinence rates for both smokers with 'inconspicuous profiles' who received standard treatment and smokers who were assigned to one of the three 'risk profiles'. In this study, these smokers achieved similarly good treatment results as smokers with an 'inconspicuous profile', irrespective of whether they had been randomly assigned to the standard treatment or the modified treatment form tailored to their respective smoking profile.