Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
MALE
ID06488443

Randomized Controlled Study Evaluating Yoga for Reducing Craving in Tobacco Dependent Men Aged 18 to 65 Who Want to Quit

Led by University of Pittsburgh · Updated on 2026-06-05

96

Participants Needed

1

Research Sites

21 weeks

Total Duration

On this page

Sponsors

U

University of Pittsburgh

Lead Sponsor

F

Fogarty International Center of the National Institute of Health

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research aims to evaluate the feasibility of using a well-designed yoga protocol to reduce craving in individuals dependent on tobacco in India. Tobacco use remains highly prevalent and underserved in the community, and yoga is a culturally accepted practice that may help people reduce craving and quit tobacco. The study focuses on men aged 18 to 65 years who are tobacco dependent and want to quit tobacco use, with the goal to assess the feasibility of yoga for this purpose.

CONDITIONS

Brief Title

Effect of Yoga on Reducing Craving in Tobacco Dependent Individuals

Who Can Participate

Age: 18Years - 65Years
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Tobacco dependent men aged 18 to 65 years
  • Fagerstrom test for tobacco dependence score of 4 or higher
  • Recruited from specified rural health centers and hospital outpatient departments
Not Eligible

You will not qualify if you...

  • Recent alcohol use within the last 3 months
  • Use of other drugs of abuse
  • Clinical diagnosis of intellectual disability
  • Major mental illnesses diagnosed within last 6 months including dementia, psychosis, recurrent depression, bipolar disorder, OCD, anxiety disorders, panic disorder, and phobias
  • Recent myocardial infarction or stroke within last 3 months
  • Physical inability to perform yoga postures due to disabilities
  • Severe hypertension (systolic BP ≥180 mmHg and diastolic BP ≥120 mmHg)
  • Seizure disorder
  • COPD stages GOLD-2, 3, or 4

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 1 week

Participants in the yoga intervention group attend one week of yoga sessions, starting with an offline session followed by six online sessions, each lasting about 60 minutes. Participants in the control group receive the WHO 5As model intervention to support quitting tobacco.

7 visits (1 offline and 6 online sessions)

Follow-up

Duration - 3 months

Participants are followed up to assess craving, relapse, and quit rates at 1 month and 3 months after the intervention.

2 visits (at 1 month and 3 months post-intervention)

Trial Site Locations

Total: 1 location

1

St.John's Medical College and Hospital

Bengaluru, Karnataka, India, 560029

Actively Recruiting

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Research Team

V

Vishwajit L Nimgaonkar, MD, PhD

T

Triptish Bhatia, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Frequently Asked Questions

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