CompletedPhase 3ACTRN12609000482268

Randomised controlled trial of Zonnic and nicotine patch (ZAP) in smoking cessation

Randomised placebo-controlled trial of Zonnic and nicotine patch in heavy smokers for smoking cessation


Sponsor

Health Research Council of New Zealand

Enrollment

1,600 participants

Start Date

Mar 12, 2010

Study Type

Interventional

Conditions

Summary

We aim to test the effect on 12 month quit rates of adding Zonnic (a nicotine mouthspray) to nicotine patch therapy compared to nicotine patch therapy plus placebo Zonnic. Subjects will receive 5 months of nicotine patch, and 6 months of Zonnic. Subjects will reduce their smoking in the first month, then quit smoking and continue to use Zonnic and patches. Abstinence will be measured at 12 months post-cessationo and verified by plasma or hair nicotine.


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 70 Yearss

Plain Language Summary

Simplified for easier understanding

This study compares the effectiveness of a nicotine mouth spray combined with a nicotine patch against a patch alone for smoking cessation. It targets heavier smokers who smoke 15 or more cigarettes per day.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Zonnic (peppermit flavoured nicotine mouthspray) plus nicotine patch compared to placebo-Zonnic plus active nicotine patch. Zonnic for 6 months, nicotine patch for 5 months. Zonnic contains 1mg nicoti

Zonnic (peppermit flavoured nicotine mouthspray) plus nicotine patch compared to placebo-Zonnic plus active nicotine patch. Zonnic for 6 months, nicotine patch for 5 months. Zonnic contains 1mg nicotine per spray, use at the discretion of the participant for first 5 months, wean during 6th month. Use patches daily with dose titrated to amount smoked using standard schedule recommended by manufacturer. In 5th month wean from patches in step-wise manner as laid out by manufacturer. Zonnic and patches both start at the second clinic visit. Quit date is the first quit day at the end of the 3 weeks of smoking reduction.


Locations(1)

New Zealand

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