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A trial looking at nortriptyline and nicotine replacement therapy to help people give up smoking

This trial compared a drug called nortriptyline and nicotine replacement therapy (NRT) with NRT alone to help people give up smoking. This trial was supported by Cancer Research UK.

Smoking is a risk factor for many cancers including lung cancer, mouth cancer, cancer of the food pipe (oesophagus), stomach cancer,  bladder cancer and kidney cancer.

Some people find nicotine replacement therapy (NRT) is very useful to help them give up smoking. But it doesn’t help everyone to give up. In this trial doctors wanted to see if an anti depressant drug called nortriptyline (Allegron) together with NRT could help people give up.

The aim of the trial was to find out if NRT and nortriptyline is better than NRT alone for people trying to give up smoking. And to find out more about the side effects.

Recruitment

Start 01/11/2003
End 30/05/2005

Phase

Other

Summary of results

The research team found that nortriptyline and NRT are both useful treatments to help people give up smoking. But the results of this trial do not show that NRT and nortriptyline together is better than either treatment alone.

The trial recruited 901 people who attended the NHS Stop Smoking Service clinics

  • Half had NRT and nortriptyline
  • Half had NRT and dummy tablet (placebo)

The researchers analysed the results in 2006. They looked at the number of people who gave up smoking and were still not smoking 6 months and 12 months after starting treatment. They found that slightly more people who had nortriptyline and NRT weren’t smoking 6 months after treatment began. But this was not significant in statistical terms. After 12 months there were a similar number of people in each treatment group who had given up smoking.

Overall, there was no difference in total nicotine withdrawal symptoms between those who used nortriptyline and NRT compared with those using placebo and NRT. But nortriptyline reduced two symptoms of nicotine withdrawal, depression and anxiety. The people who took nortriptyline reported more problems with constipation and a dry mouth.

We have based this summary on information from the team who ran the trial. The information they sent us has been reviewed by independent specialists (peer reviewed) and published in a medical journal. The figures we quote above were provided by the trial team. We have not analysed the data ourselves.

Chief Investigator

Dr Paul Aveyard

This is Cancer Research UK trial number CRUK/03/026. 

Supported by

Cancer Research UK
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Updated: 6 November 2013