Effect of Yoga on Reducing Craving in Tobacco Dependent Individuals

NCT06488443 | Recruiting

• 2 other identifiers: STUDY23050176D43TW009114
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

Yoga is a culturally acceptable practice that can reduce craving and help people quit tobacco. There is a need to evaluate the feasibility of implementation of a well- designed yoga protocol to address craving in individuals who use tobacco in India.

Conditions

Tobacco Dependence

Keywords

Tobacco dependence; Smoking; Craving; Fagerstorm test

Outcome Measures

Primary Outcomes (4)

• Feasibility of yoga based intervention

  To evaluate the feasibility of yoga-based intervention in changing craving of tobacco in comparison to WHO 5As intervention on individuals who want to quit tobacco use with Visual Analogue scale (upto score 3 not useful: scores 4,5,6 neutral; 7,8,9, 10 useful) Minimum score is 0 and maximum score is 10

  After one week of intervention

• Craving of tobacco after intervention

  To evaluate the feasibility of yoga-based intervention in changing craving of tobacco measured by Brief Questionnaire of Smoking Urges in comparison to WHO 5As intervention on individuals who want to quit tobacco use using (Scale is 10 items likert scale and total of all item scores is the score, more the score more is the craving)Minimm score is 0 and maximum is 100.

  After one week of intervention

• Craving of tobacco one month follow up

  To evaluate the feasibility of yoga-based intervention in changing craving of tobacco measured by Brief Questionnaire of Smoking Urges in comparison to WHO 5As intervention on individuals who want to quit tobacco use (Scale is 10 items likert scale and total of all item scores is the score, more the score more is the craving) Minimum score is 0 and maximum is 100.

  1 month after intervention

• Craving of tobacco three months follow up

  To evaluate the feasibility of yoga-based intervention in changing craving of tobacco (Scale is 10 items likert scale and total of all item scores is the score, more the score more is the craving)measured by Brief Questionnaire of Smoking Urges in comparison to WHO 5As intervention on individuals who want to quit tobacco use. The minimum score is 0 and maximum score is 100.

  3 months after intervention

Secondary Outcomes (9)

• Relapse rate of tobacco use (Number of participants start using tobacco again)

  After one week of intervention

• Relapse rate of tobacco use(One month sustainability) ((Number of participants start using tobacco again)

  1 month after intervention

• Relapse rate of tobacco use (Three months sustainability)(Number of participants start using tobacco again)

  3 months after intervention

• Quit rate of tobacco

  After one week of intervention

• Quit rate of tobacco (One month sustainability)

  1 month after intervention

Study Arms (2)

Intervention-yoga

EXPERIMENTAL

Participants in intervention arm will receive intervention from an instructor who would be trained in the intervention by the yoga adviser. One week of yoga intervention with the first session offline and the rest of the 6 sessions online

Behavioral: Yoga

WHO 5As model intervention

ACTIVE COMPARATOR

The control group will be given the WHO 5As model intervention to help patients ready to quit.

Behavioral: WHO 5As model intervention

Interventions

Yoga BEHAVIORAL

Participants in yoga arm will receive intervention from an instructor who would be trained in the intervention by the yoga adviser.All the yoga exercises selected for this study are low-impact and involve highly controlled movements. All yoga exercises will be taught and supervised by a skilled yoga-instructor. The yoga-instructor will take great care to emphasize to participants that they should not go beyond their usual range of motion/comfort for any of the yoga exercises.

Intervention-yoga

WHO 5As model intervention BEHAVIORAL

WHO 5As model to help patients ready to quit. The five major steps to intervention are the "5 A's": Ask, Advise, Assess, Assist, and Arrange.

WHO 5As model intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients with recent alcohol use (last 3 months) and use of other drugs of abuse
• Patients with clinical diagnosis of Intellectual disability
• 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.
• 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.
• Patients with severe hypertension(SBP≥180mmHg and BP≥120mmHg)
• Patients with seizures disorder
• Patients with COPD(GOLD-2,3 and 4)

Sponsors & Collaborators

• University of Pittsburgh: lead
• Fogarty International Center of the National Institute of Health: collaborator
• St.John's Medical College and Hospital: collaborator

Study Sites (1)

St.John's Medical College and Hospital

Bengaluru, Karnataka, 560029, India

RECRUITING

MeSH Terms

Conditions

Tobacco Use Disorder; Smoking

Interventions

Yoga

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Behavior

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Exercise Movement Techniques; Physical Therapy Modalities

Study Officials

• Vishwajit Nimgaonkar, MD, PhD

  University of Pittburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vishwajit L Nimgaonkar, MD, PhD

CONTACT

4127265164; vishwajitnl@upmc.edu

Triptish Bhatia, PhD

CONTACT

+919910107210; trb16@pitt.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessor will be blinded to the randomisation. Principal investigator will not be involved in randomization of participants.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: The proposed study is a Randomized controlled trial.. It is two arm study, intervention arm and control arm. Intervention arm will be imparted yoga while control arm will be given the WHO 5As model intervention.

Study Record Dates

• First Submitted: June 18, 2024
• First Posted: July 5, 2024
• Study Start: November 1, 2024
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 2, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: One year after publication of this study.
• Access Criteria: For individual participant data, meta-analysis.

Locations

IN (1)