Tobacco DependenceNCT06488443
Effect of Yoga on Reducing Craving in Tobacco Dependent Individuals
A study testing Yoga and WHO 5As model intervention in people with Tobacco Dependence, run by University of Pittsburgh at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Tobacco Dependence
- What is being tested?
- Yoga and WHO 5As model intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteIndia
- Study dates
- 1 Nov 2024to 31 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site, 1 recruiting
- Recruiting
St.John's Medical College and Hospital
Bengaluru, Karnataka, 560029
Jewel Jones, MBBS, +919902487374, drjohns.jewel@gmail.com
Smita Deshpande, MD, +919312654702, smitadeshp@gmail.com
About this study
Official title: Randomized Control Study to Study the Effect of Yoga on Reducing Craving in Tobacco Dependent Individuals Who Want to Quit Tobacco Use
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.
Read the detailed description
There is a high prevalence of tobacco use in the community that continue to remain underserved in terms of intervention and support for their tobacco use. Yoga is a culturally acceptable practice that can reduce craving and help people quit tobacco. However, we didn't come across Indian studies looking at yoga to reduce craving in individuals who use 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.
Aim: To study the feasibility of yoga in reducing craving in individuals who use tobacco
Objectives:
Primary
- To evaluate the feasibility of yoga based intervention on craving in tobacco dependent individuals who want to quit tobacco use Secondary/tertiary
- To assess the effect on abstinence
- To assess quit rate
Sampling frame:
Screened positive participants will be 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 super speciality OPD at SJMCH
.
Sample recruitment/sampling method:
Participants who fulfilled the inclusion criteria will be approached by the principal investigator and/or junior research fellow, and those who agreed to participate in the study will be randomly allocated to one of two groups via simple randomization. Randomisation will be computerised. This will be done in blocks of 10. Outcome assessor will be blinded to the randomisation. Principal investigator will not be involved in randomization of participants.
Training/ interventions/assessments/ procedures in the study -Participants in yoga arm will receive intervention from an instructor who would be trained in the intervention by the yoga adviser.
Procedure:
Screening positive participants fulfilling eligibility criteria, information regarding study is given and informed consent is documented. Selection of a quit date within 21 weeks.
Standard of living index(SLI) or Modified Kuppuswamy Scale for sociodemographic data (10mins), Fagerstrom scale(5 mins), Motivation to stop smoking (1 min) .
Participants are randomized into intervention and TAU groups with 48 participants each.
For intervention group, sixty minute yoga session will be imparted. The first session shall be offline, the rest of the 6 sessions shall be online.. After Completion all assessments will be done again both of intervention and TAU groups.Follow up at 21 weeks, 1 month and at 3 months.
-To assess relapse
Hypothesis Yoga will be a feasible method to reduce craving in tobacco dependent individuals who want to quit tobacco use
- Conditions
- Tobacco Dependence
- Being tested
- Yoga, WHO 5As model intervention
- Keywords
- Tobacco dependence, Smoking, Craving, Fagerstorm test
- Medical subject headings
- Tobacco Use Disorder, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YogaBehavioural
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.
WHO 5As model interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Behavioral: WHO 5As model intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 months after intervention
Secondary outcomes (9)
Relapse rate of tobacco use (Number of participants start using tobacco again)
To compare effect of yoga Relapse rate of tobacco use on abstinence with WHO 5As intervention group
Measured: After one week of intervention
Relapse rate of tobacco use(One month sustainability) ((Number of participants start using tobacco again)
To compare effect of yoga intervention on relapse rate of tobacco use with WHO 5As intervention group
Measured: 1 month after intervention
Relapse rate of tobacco use (Three months sustainability)(Number of participants start using tobacco again)
To compare effect of yoga intervention on relapse rate of tobacco use with WHO 5As intervention group
Measured: 3 months after intervention
Quit rate of tobacco
To compare the change in quit rate after yoga intervention with WHO 5As intervention group
Measured: After one week of intervention
Quit rate of tobacco (One month sustainability)
To compare the change in quit rate after yoga intervention with WHO 5As intervention group
Measured: 1 month after intervention
Quit rate of tobacco (Three month sustainability)
To compare the change in quit rate after yoga intervention with WHO 5As intervention group
Measured: 3 months after intervention
Relapse rate of smoking
To compare the change in relapse rate after yoga intervention with that of WHO 5As intervention group
Measured: After one week of intervention
Relapse rate of smoking (One month sustainability)
To compare the change in relapse rate after yoga intervention with that of WHO 5As intervention group
Measured: 1 month after intervention
Relapse rate of smoking (Three month sustainability)
To compare the change in relapse rate after yoga intervention with that of WHO 5As intervention group
Measured: 3 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2024
- Study start1 Nov 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco DependenceStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Fogarty International Center of the National Institute of Health, St.John's Medical College and Hospital
- Responsible party
- Principal investigator, Vishwajit Nimgaonkar, MD PhD, University of Pittsburgh
- Investigators
- Vishwajit Nimgaonkar, MD, PhD, Principal investigator, University of Pittburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06488443
- Sponsor's protocol ID
- STUDY23050176
- Other IDs
- D43TW009114
- Status last verified
- Jun 2026
- First submitted
- 18 Jun 2024
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in the article, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Control Study to Study the Effect of Yoga on Reducing Craving in Tobacco Dependent Individuals Who Want to Quit Tobacco Use
- ClinicalTrials.gov ID
- NCT06488443
- Acronym / sponsor ID
- STUDY23050176
- Conditions
- Tobacco Dependence
- Keywords
- Tobacco dependence, Smoking, Craving, Fagerstorm test
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Fogarty International Center of the National Institute of Health, St.John's Medical College and Hospital
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 5 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
There is a high prevalence of tobacco use in the community that continue to remain underserved in terms of intervention and support for their tobacco use. Yoga is a culturally acceptable practice that can reduce craving and help people quit tobacco. However, we didn't come across Indian studies looking at yoga to reduce craving in individuals who use 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.
Aim: To study the feasibility of yoga in reducing craving in individuals who use tobacco
Objectives:
Primary
- To evaluate the feasibility of yoga based intervention on craving in tobacco dependent individuals who want to quit tobacco use Secondary/tertiary
- To assess the effect on abstinence
- To assess quit rate
Sampling frame:
Screened positive participants will be 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 super speciality OPD at SJMCH
.
Sample recruitment/sampling method:
Participants who fulfilled the inclusion criteria will be approached by the principal investigator and/or junior research fellow, and those who agreed to participate in the study will be randomly allocated to one of two groups via simple randomization. Randomisation will be computerised. This will be done in blocks of 10. Outcome assessor will be blinded to the randomisation. Principal investigator will not be involved in randomization of participants.
Training/ interventions/assessments/ procedures in the study -Participants in yoga arm will receive intervention from an instructor who would be trained in the intervention by the yoga adviser.
Procedure:
Screening positive participants fulfilling eligibility criteria, information regarding study is given and informed consent is documented. Selection of a quit date within 21 weeks.
Standard of living index(SLI) or Modified Kuppuswamy Scale for sociodemographic data (10mins), Fagerstrom scale(5 mins), Motivation to stop smoking (1 min) .
Participants are randomized into intervention and TAU groups with 48 participants each.
For intervention group, sixty minute yoga session will be imparted. The first session shall be offline, the rest of the 6 sessions shall be online.. After Completion all assessments will be done again both of intervention and TAU groups.Follow up at 21 weeks, 1 month and at 3 months.
-To assess relapse
Hypothesis Yoga will be a feasible method to reduce craving in tobacco dependent individuals who want to quit tobacco use
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention-yoga | Experimental | Behavioral: YogaParticipants 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 |
| WHO 5As model intervention | Active comparator | Behavioral: WHO 5As model interventionThe control group will be given the WHO 5As model intervention to help patients ready to quit. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- -Tobacco dependent individuals (Fagerstrom test for tobacco dependence score more than or equal to 4)
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| YogaParticipants 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. | Behavioural | Intervention-yoga |
| WHO 5As model interventionWHO 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. | Behavioural | WHO 5As model intervention |
Primary outcome
Feasibility of yoga based intervention
Time frame: After one week of 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
Craving of tobacco after intervention
Time frame: After one week of 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.
Craving of tobacco one month follow up
Time frame: 1 month 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 (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.
Craving of tobacco three months follow up
Time frame: 3 months after intervention
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.
9 secondary outcomes
Relapse rate of tobacco use (Number of participants start using tobacco again)
Time frame: After one week of intervention
Relapse rate of tobacco use(One month sustainability) ((Number of participants start using tobacco again)
Time frame: 1 month after intervention
Relapse rate of tobacco use (Three months sustainability)(Number of participants start using tobacco again)
Time frame: 3 months after intervention
Quit rate of tobacco
Time frame: After one week of intervention
Quit rate of tobacco (One month sustainability)
Time frame: 1 month after intervention
Quit rate of tobacco (Three month sustainability)
Time frame: 3 months after intervention
Relapse rate of smoking
Time frame: After one week of intervention
Relapse rate of smoking (One month sustainability)
Time frame: 1 month after intervention
Relapse rate of smoking (Three month sustainability)
Time frame: 3 months after intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in the article, after deidentification (text, tables, figures, and appendices).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Vishwajit Nimgaonkar, MD, PhD principal investigator
University of Pittburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoga and WHO 5As model intervention in people with Tobacco Dependence, run by University of Pittsburgh at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vishwajit L Nimgaonkar, MD, PhD (4127265164, vishwajitnl@upmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of yoga based intervention (time frame: After one week of intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.