Vaporised nicotine products versus nicotine replacement therapy for tobacco smoking cessation among low-socioeconomic status smokers: A randomised controlled trial.

Phase 4

Completed

• Conditions: Tobacco smoking; Public Health - Health service research; Mental Health - Addiction

• Registration Number: ACTRN12621000076875
• Lead Sponsor: niversity of New South Wales

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-01-29
• Study Completion: 2022-12-08
• Last Update Posted: 1 May 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 1058

Inclusion Criteria

Participants can be included if they meet the following criteria:
•willing to allow the research team and study clinician to access their data for quality assurance and to maintain the integrity of the trial;
•18 years of age or older;
•receiving a government pension or allowance (proxy for low-SES);
•are a current daily smoker;
•interested in quitting smoking and using the study products;
•willing to make a quit attempt in the next two weeks;
•have a mobile phone that can receive text messages;
•available for follow-up over a 7-month period;
•agree to use the allocated study product and refrain from using another quit smoking medication whilst using the study products;
•willing to receive daily quit support text messages during the treatment period (with the option to opt out during the study);
•speak English and can provide consent;
•willing to allow the research team to share the collected contact details for the purpose(s) of (i) the study doctor to make contact if required, (ii) the Social Research Centre to conduct two telephone interviews, and (iii) research staff from UNSW or a third-party contracted research organisation mailing out the study products;
•willing for the study clinician to call if they need more information about health status and to inform the UNSW research team of their decision;
•willing to complete two telephone check-in calls with the UNSW research team; and
•willing to complete baseline and follow-up telephone interviews with the SRC.

Exclusion Criteria

Participants will be excluded if they are:
•currently participating in another quit smoking program or study;
•currently using any quit smoking medications or products (i.e. NRT, bupropion [Zyban], varenicline [Champix], clonidine, nortriptyline, cytisine, vaporised nicotine product/electronic or e-cigarettes/inhalers or other quit smoking medication or product);
•diagnosed with unstable angina (i.e. chest pain that occurs suddenly and becomes worse over time, which happens seemingly without cause, where patient may be resting or asleep);
•hospitalised for stroke, heart attack, or another heart-related condition in the last two weeks;
•women who are pregnant, breastfeeding or planning to become pregnant in the next 7 months; and
•deemed medically unfit, by the study clinician, to participate at the time of screening (see below).

Study & Design

• Study Type: Interventional
• Study Design: Not specified