Trialling smoking cessation drug among Maori: a nurse researcher is encouraged by preliminary results from a research project assessing the effectiveness of the smoking cessation medication Brupopion within a Maori client group.

FOR THE past two years, nurse researcher Carmen Timu-Parata has been involved in trialling the smoking cessation drug Bupropion (trading under the name Zyban) on a Maori client group. This has been her first research role and one that's proved a very interesting experience.

The project, which is funded by the pharmaceutical company GlaxoSmithKline New Zealand, was conducted independently by P3 Research in Wellington, with the assistance of the Maori Health Unit at Wellington Hospital. The trial is the first New Zealand study of Brupopion carried out with a solely Maori population and follows many international trials of the medication. Timu-Parata is of Ngali Kahungunu descent and a registered nurse since 1988. She's had a long association with Maori health providers in the Wellington region, so was an ideal candidate to join the research team. In order for the trial to gain ethical approval from the Maori Health Unit and the Medical Research Institute, it was essential Maori were involved in all aspects of the research.

The rationale behind the project was primarily the high smoking rates among Maori. According to P3 Research director and doctor Shaun Holt, 40-50 percent of Maori smoke, compared to 20 percent of non-Maori. Maori women have the highest rate of lung cancer in the world, with three quarters of Maori mothers smokers. There are estimated to be 4500 smoking-related deaths each year throughout the New Zealand population. One of the benefits of Zyban, says Holt, is that, unlike other treatments, it does not deliver nicotine. Only two to six percent of smokers manage to quit each year without medical intervention. (1)

The study objectives were to determine the short and long-term "quit rate" achievable in a Maori population with Bupropian and counselling, to compare this with the rate achieved by counselling and placebo, and to assess the safety of Bupropion.

For the first ten months, emphasis was on recruiting a client base of around 140 participants. Eventually, 136 people were enrolled, three quarters of whom live north of Wellington, in Porirua and in the Kapiti region.

"The criteria to join the trial was quite stringent," Timu-Parata explained. "People needed to have smoked more than ten cigarettes a day for the past year and could not be drug or alcohol abusers. They had to really want to give up smoking, be in good health and not pregnant. This was due to safety concerns over the use of Brupopion with certain pre-existent conditions, eg epilepsy and renal disease. We needed people to be very honest about their smoking rates and other lifestyle factors."

Recruitment was achieved through newspaper and radio advertising and via hui held on marae and in sports clubs throughout the area. Each participant was seen by a doctor to assess their suitability and to gain consent. Following this, Timu-Parata conducted her own physical examination and explained the trial and its various stages. The research was conducted as a double blind test, with two thirds of the participants on Brupopion and one third on a placebo. Neither the participant nor the researcher knew whether they had taken Brupopion or a placebo until one year after they began the test.

Timu-Parata followed each participant for a year, with regular visits or phone contact during that time. After the initial screening visit, the participants began a seven-week course of Brupopion or placebo, which aimed to assist them with withdrawal symptoms. They set themselves an agreed target quit date and were assessed at regular intervals for their success at remaining smokefree. "The most successful participants were hardcore smokers who had already tried to give up smoking several times in the past," said Timu-Parata. "Offering them support and phone counselling was a crucial part of the programme, as well as ensuring they established good support networks within their whanau and communities.

"Those that were not so successful this time were often those who didn't have the best motives for taking part in the trial. They were probably doing it to please other people rather than because they wanted to give up smoking for themselves. I have observed some real health gains in those who have remained smokefree for a year or more. Their confidence and self esteem have increased and their families have benefitted from not being subjected to passive smoking. For others, simply being part of the trial will become part of their quitting history. Some people will have up to eight attempts to give up smoking before achieving permanent success."

At present, Pharmac does not subsidise Brupopion, which can only be prescribed by a doctor, with the medication costing around $300 for a seven-week course. This fact gives the project an obvious political aspect. However, Timu-Parata was careful to remain detached from these considerations. "I remained neutral about the trial's purpose and tried to be as honest as possible when I explained the background to clients. I told people about the options they had for quitting smoking, including nicotine patches and gum, going 'cold turkey' or using a medication like Brupopion. People need as much information as possible when making these sorts of decisions. I am not a drug rep. I give people the information they need in order to make an informed choice about their health."

Timu-Parata is pleased her work on the trial has combined hands-on nursing work with counselling and support. On each of her follow-up visits, she assessed participants' smoking status using a smokefree meter, checked their weight and blood pressure, and questioned them about any withdrawn symptoms or reactions to the medication. Analysing the statistics at the completion of the project will be the only aspect of the work unfamiliar to her.

One of the real challenges participants faced was how they coped during the weeks immediately following completion of the Brupopion or placebo course. Attending social events where friends were smoking could be very stressful, so finding an appropriate quit date was important. "Smoking can be a very sociable thing. For many smokers, it's the way they make connections with others. Learning new ways to make these connections or making new smokefree friends is often the key to giving up," said Timu-Parata.

Both Timu-Parata and Holt are cautiously optimistic about the effectiveness of Brupopion in helping people give up smoking. Initial results at three months after the trial began show nearly 47 percent of participants remained smokefree compared to nearly 22 percent on a placebo. The drug was shown to be generally safe and well-tolerated, though 26 percent said they experienced insomnia. Those on a placebo gained more weight than those on Brupopion.

Timu-Parata is very appreciative of the support she has received from Te Wananga-o-Raukawa in Otaki for her work on the project. The smokefree Maori university and its Te Ohaki committee, which has a particular oversight of student welfare and health, have provided her with a room and computer, ongoing support for her work with participants, and technical help in putting together a video about the project. Comments from interviewees include such things as "I wanted to see my children and grandchildren grow up", "Giving up smoking is the best thing I have ever done for myself" and "Not smoking makes me feel clean, healthier and more in control of my life". Miriona Johnson of Otaki (Ngati Ruakawa ki te Tonga) said she had been smoking since the age of nine. Smokefree for almost two years, she now works as a quit coach with the health provider Te Runanga O Raukawa. Her children are delighted she has managed to give up smoking ("She's getting healthier," says son Ihaka on the video) and she has also been able to persuade other family members to give up.

Tania Bristowe (Ngati Porou), who works in Te Wananga-o-Raukawa's audio visual unit, had promised her two daughters she would give up smoking (she smoked around 25 cigarettes a day) but had never thought she could. "Carmen was the only non-smoking friend I had when I went on the trial. I have since found friends who are smokefree and now find smoking disgusting. I feel very proud that I have been able to achieve the promises I made to my daughters." The interviewees all noted the support Timu-Parata had provided them and how Brupopion had helped stop their craving for a cigarette.

With the research project now nearing its end, Timu-Parata has reduced her hours to part-time and will be making her last client visit at the beginning of next month. She and Holt will analyse the data in April and feed the results back to the participants and their communities later that month. Final results are expected to be published in an international medical journal later this year. One of the expected recommendations will be a call to Government for Brupopion to be included in a package of smoking cessation support, including counselling.

For Timu-Parata, the end of the trial will mark a return to academic studies and the finishing of her Master's thesis. However, the pull to continue working as a nurse researcher has become strong and she expects her nursing career to continue in this direction in the future.

REFERENCE

(1)) Galgali G, Beaglehole R, Scragg R, Tobias M. (1997) Potential for prevention of premature death and disease in New Zealand. NZ Med J; 110: 7-10.