Effect of yoga on reducing craving in tobacco dependent individuals

Phase 2/3

Recruiting

• Conditions: Nicotine dependence,

• Registration Number: CTRI/2023/10/058779
• Lead Sponsor: Jewel Johns

Brief Summary

We aim to evaluate the feasibility of yoga- based intervention on craving in tobacco dependent individuals who want to quit tobacco use using a single-site, parallel group, two-arm randomised controlled trial design in 96 participants. The eligible and consenting participants will be screened for tobacco dependence on Fagerstrom scale. A quit date will be selected within 2 weeks.

The participants in yoga arm will receive a yoga intervention by a yoga instructor. The first session will be offline while the rest of the 6 sessions will be online.  Motivation to stop smoking scale and Brief Questionnaire of Smoking Urges would be used. Participants in intervention arm will receive yoga intervention and control group will receive WHO 5As model.  Questionnaire of Smoking Urges and the Visual Analogue Scale will be repeated at the end of 2 weeks of yoga.  Participants that relapse can rejoin the group they belonged to. Participants will be encouraged to use the techniques they have learned to overcome craving. Quit rate, relapse and abstinence will be assessed at 2 weeks, 1 month and 3 months follow ups

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-28
• Last Update Posted: 2024-12-10

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Male
• Target Recruitment: 96

Inclusion Criteria

1.Tobacco dependent individuals (Fagerstrom test for tobacco dependence score more than or equal to 4) 2.Men aged 18 to 65 years 3.Recruited from Rural community health and training centre, Mugalur, Tobacco cessation centre and OPDs of Department of general medicine, pulmonary medicine, cardiology,ENT and dental surgery and other super speciality OPD at SJMCH.

Exclusion Criteria

• 1.Patients with recent alcohol use (last 3 months) and use of other drugs of abuse 2.Patients with clinical diagnosis of Intellectual disability 3.Comorbid Major mental illness including Dementia, Psychosis, Recurrent depressive disorder, Bipolar affective disorder, OCD, generalized anxiety disorder, Panic disorder and Phobias, diagnosed within the last 6 months.
• 4.Patients with recent MI and stroke in the last 3 months or those physically unable to perform the yoga postures due to physical disabilities determined by clinical interview 5.Patients with severe hypertension(SBP≥180mmHg and BP≥120mmHg) 6.Patients with seizures disorder 7.Patients with COPD.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To study the feasibility of yoga in reducing craving in individuals who use tobacco	3months

Secondary Outcome Measures

Name	Time	Method
1. Quit Rate	2. Relapse

Trial Locations

Locations (1)

St Johns Medical College Hospital, Bangalore; 🇮🇳 Bangalore, KARNATAKA, India

St Johns Medical College Hospital, Bangalore

🇮🇳Bangalore, KARNATAKA, India

Dr Jewel Johns

Principal investigator

9902487374

drjohns.jewel@gmail.com