Comparing different ways to help people stop using smokeless tobacco products in India, Pakistan and Bangladesh

Not Applicable

Suspended

Conditions: Mental and Behavioural Disorders
Smokeless tobacco use

Registration Number: ISRCTN65109397

Lead Sponsor: niversity of York

Brief Summary: 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)

Detailed Description: Not available

Recruitment & Eligibility

Status: Suspended

Sex: All

Target Recruitment: 264

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Self-reported continuous abstinence to all forms of tobacco (smoked and smokeless) at 26 weeks after the quit date, verified by carbon monoxide breath test and salivary cotinine assessment. Participants will be asked a set of questions (one for each type of tobacco product) asking: have you used this product at all since your quit date? The possible responses are: no, not even once; yes, 1- 5 times; yes, >5 times. Participants who report consuming tobacco <5 times since quit date, as well as having CO levels that are consistent with abstinence, will be considered as abstinent. <br>2. Feasibility of conducting a full trial on smokeless tobacco cessation, particularly the feasibility of delivering the intervention, recruitment, randomisation and retention, as well as measures for data collection in a full trial, will be demonstrated through analysis of trial data, as well as preliminary process evaluation and economic assessments

Secondary Outcome Measures

Name	Time	Method
Point abstinence to all forms of tobacco (smoked and smokeless) at 6 and 12 weeks following quit date. Participants will be asked about the their tobacco use (all forms) in the past 7 days. Those who report not to have used any tobacco product in the past 7 days will be labelled as abstinent, while those who have used any tobacco product >5 times will be labelled as non-abstinent.