Clinical trial NCT06488443: Effect of Yoga on Reducing Craving in Tobacco Dependent Individuals
Official title: Randomized Control Study to Study the Effect of Yoga on Reducing Craving in Tobacco Dependent Individuals Who Want to Quit Tobacco Use
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tobacco Dependence
Keywords: Tobacco dependence
Smoking
Craving
Fagerstorm test
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Fogarty International Center of the National Institute of Health
name: St.John's Medical College and Hospital
First posted: 2024-07-05
Enrollment: 96
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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

Eligibility criteria: Inclusion Criteria:

* -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

Exclusion Criteria:

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)

Primary outcomes:
measure: Feasibility of yoga based intervention
timeFrame: After one week of intervention
measure: Craving of tobacco after intervention
timeFrame: After one week of intervention
measure: Craving of tobacco one month follow up
timeFrame: 1 month after intervention
measure: Craving of tobacco three months follow up
timeFrame: 3 months after intervention
Secondary outcomes:
measure: Relapse rate of tobacco use (Number of participants start using tobacco again)
timeFrame: After one week of intervention
measure: Relapse rate of tobacco use(One month sustainability) ((Number of participants start using tobacco again)
timeFrame: 1 month after intervention
measure: Relapse rate of tobacco use (Three months sustainability)(Number of participants start using tobacco again)
timeFrame: 3 months after intervention
measure: Quit rate of tobacco
timeFrame: After one week of intervention
measure: Quit rate of tobacco (One month sustainability)
timeFrame: 1 month after intervention
measure: Quit rate of tobacco (Three month sustainability)
timeFrame: 3 months after intervention
measure: Relapse rate of smoking
timeFrame: After one week of intervention
measure: Relapse rate of smoking (One month sustainability)
timeFrame: 1 month after intervention
measure: Relapse rate of smoking (Three month sustainability)
timeFrame: 3 months after intervention
Other outcomes:
Locations:
city: Bengaluru
country: India
facility: St.John's Medical College and Hospital
state: Karnataka
Study officials:
affiliation: University of Pittburgh
name: Vishwajit Nimgaonkar, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: