Addressing Smokeless Tobacco Research and capacity building in South Asia (ASTRA): A randomised, controlled, feasibility trial for smokeless tobacco cessation

niversity of York0 个研究点目标入组 264 人开始时间: 2019年9月17日最近更新: 2024年6月18日

适应症

试验速览

2022 Protocol article in https://pubmed.ncbi.nlm.nih.gov/35996179/ (added 23/08/2022) 2024 Results article in https://pubmed.ncbi.nlm.nih.gov/38769627/ (added 04/06/2024)

•1. Self-reported daily user of ST products at least for the last 6 months or ST use on >25 days in the past month
•2. Aged >18 years at the time of recruitment
•3. Able to provide informed consent
•4. Motivated and willing to quit ST use within the next 30 days.

•1. Self-reported users of any combustible tobacco product (cigarettes, bidis, hookah) or e-cigarettes in the past 30 days or those having carbon monoxide (CO) levels >10 ppm, identified by breath test
•2. Pregnant or breastfeeding women
•3. Individuals with health conditions that warrant caution in using NRT and have previously been excluded in trials of nicotine replacement in smoking. These will be assessed by participant self-report at the pre-trial screening by asking participants whether they have suffered angina pectoris, myocardial infarction or stroke in the past 3 weeks.
•4. Individuals who are already on an existing treatment, either pharmacological or behavioral, for tobacco cessation
•5. ST-using individuals with diagnosis of oral cancer. Due to the nature of care required, any such individuals identified during the recruitment process will receive a direct referral to specialist care for treatment.

发起方

niversity of York