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

Phase 3

Completed

• Conditions: Tobacco Addiction; Smoking Cessation; Mental Health - Addiction

• Registration Number: ACTRN12609000482268
• Lead Sponsor: Health Research Council of New Zealand

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-06-18
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 1600

Inclusion Criteria

Smokers of 15 or more cigarettes per day, with Fagerstrom Test of Nicotine Dependence score of 3 or greater.

Exclusion Criteria

Any serious medical condition, history of peptic ulcer, cardiovascular disease, pregnancy, breastfeeding, inadequate contraception.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Post-cessation smoking abstinence assessed by self-report and hair nicotine. Hair nicotine testing involves the collection of a sample of hair from the head, which is analysed in the laboratory to measure its nicotine content.[12 months post smoking cessation date.];Continuous smoking abstinence between quit date and end of study by self-report[Over the 12 month period after smoking cessation. During this period continuous smoking abstinence is measured by self-report on daily diary cards from Week 2 to Week 5, and for a fortnight every month thereafter. It is biochemically verified by exhaled carbon monoxide tests at each clinic visit (1, 3, 6, and 12 months post smoking cessation) and by the nicotine content of a sample of hair taken from the head at 12 months post-smoking cessation.]

Secondary Outcome Measures

Name	Time	Method
Abstinence rates at 3 months verified by exhaled carbon monoxide[3 months post smoking cessation.];Abstinence rates at 6 months assessed by exhaled carbon monoxide.[6 months post smoking cessation.];Continued use of Zonnic after the planned stop date, assessed by self-report.[Between stop date (after 6 months use of Zonnic) and end of the study. This will be assessed by self-report at clinic visits at 3, 6 and 12 months post smoking-cessation.];Correlation between 12 month quit rate, and the magnitude of reduction in brief-Questionnaire of Smoking Urges score pre and post first use of Zonnic at Visit 2.[Visit 2 is the start of using Zonnic, and 12 month quit rate is determined 12 months post smoking cessation.];Abstinence rates at 1 month post quit.[The 1 month quit rate will be assessed one month after the subject's quit date, which is 3 weeks after they start taking the nicotine replacement therapy]