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Impact of Smoke Free Public Places (Smoke Free Cabs) on Cab Drivers in Mumbai

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ClinicalTrials.gov Identifier: NCT02354638
Recruitment Status : Completed
First Posted : February 3, 2015
Last Update Posted : April 30, 2018
Sponsor:
Information provided by (Responsible Party):
Gauravi Ashish Mishra, Tata Memorial Hospital

Brief Summary:

In addition to the passengers smoking inside the cab, the taxi drivers,are themselves addicted to smoking and/ or use of smokeless tobacco. Since tobacco is highly addictive, the cab drivers using tobacco need help in quitting. It is also necessary to raise the awareness of the cab drivers with respect to the hazards of tobacco and significance of the smoke free legislation.

It's been six years since the implementation of rules prohibiting smoking in public places and a re-look at the compliance to this regulation is necessary. The study will also help tobacco users to quit their habits. They will get screened for oral premalignant and malignant lesions.

Also, the cab drivers may pass on some effective messages regarding importance of keeping oneself away from tobacco, to the customers while commuting. In view of the above background, the current study is proposed to look at all these aspects.

The findings of the study will be certainly generating useful information with regards to lacunae in the existing system for appropriate implementation and for strengthening anti tobacco advocacy in our country.


Condition or disease Intervention/treatment Phase
Compliance Behavioral: Tobacco users Drug: Pharmacotherapy Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Screening
Official Title: Impact of Smoke Free Public Places (Smoke Free Cabs) on Cab Drivers in Mumbai, India
Study Start Date : December 2014
Actual Primary Completion Date : April 2018
Actual Study Completion Date : April 2018

Arm Intervention/treatment
Experimental: Tobacco users: behavioural counseling
The cab drivers using tobacco will be invited to participate in the tobacco cessation programme at the TCC and will receive three monthly follow-up for one year. Thus intervention will be in the form of behavioural therapy and pharmacotherapy (if required)
Behavioral: Tobacco users
Various tobacco cessation interventions in the form of one to one counseling, focus group discussions, role plays, games etc. will be used in the tobacco users.

Drug: Pharmacotherapy

Pharmacotherapy will also be prescribed as per the need assessment consisting of:

Nicotine Chewing Gums:

Dose: 2 mg/4 mg, 10-15 pieces per day with maximum dose of 24 pieces/day depending on cravings.Total Duration: 12 weeks Duration of treatment: Higher dose for 4-6 weeks, with weaning till 2-3 months

Nicotine Transdermal patches:

Dose: 7 mg/10 mg/14 mg/21 mg -for 24-hours use. Total Duration: 12 weeks Duration of treatment: Higher strength patch for 2 weeks and depending on cravings will be gradually decreased till 4 weeks

Other Name: Nicotine replacement therapy

No Intervention: Non Users
The cab drivers who are not using tobacco in any form will not receive any type of intervention



Primary Outcome Measures :
  1. Knowledge, Attitude & practice (change in the baseline KAP) [ Time Frame: 30 months ]
    a) The


Secondary Outcome Measures :
  1. Attitude regarding implementation of smoke free policy (perceptions and attitude of cab drivers) [ Time Frame: 30 months ]
    b) The perceptions and attitude of cab drivers regarding implementation of smoke free cab policy.

  2. Oral cancer detection by oral screening [ Time Frame: 30 months ]
    c)The results of oral cancer screening in the form of oral pre-cancers and cancers detected

  3. Quit rates (self reported quit rates) [ Time Frame: 30 months ]
    d) The success of tobacco cessation programme in the form of self reported quit rates at the end of one year

  4. Reactions towards no tobacco messages (Reactions of the commuters and their own perceptions) [ Time Frame: 30 months ]
    e) Reactions of the commuters and their own perceptions towards the no tobacco messages conveyed to the customers while traveling



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 400 Cab drivers ferrying customers near Tata Memorial Hospital on a regular basis

Exclusion Criteria:

  • Any Cab drivers outside the category as mentioned in the proposal

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02354638


Locations
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India
Gauravi A. Mishra
Mumbai, Maharashtra, India, 400012
Sponsors and Collaborators
Tata Memorial Hospital
Investigators
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Principal Investigator: Gauravi A Mishra, Assoc Prof Tata Memorial Hospital, Mumbai
Principal Investigator: Sharmila A Pimple, Professor Tata Memorial Hospital, Mumbai

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Responsible Party: Gauravi Ashish Mishra, Associate Professor & Physician, Tata Memorial Hospital
ClinicalTrials.gov Identifier: NCT02354638     History of Changes
Other Study ID Numbers: TMHPOCAB2015
First Posted: February 3, 2015    Key Record Dates
Last Update Posted: April 30, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Gauravi Ashish Mishra, Tata Memorial Hospital:
Perceptions
Education and evaluate post intervention KAP
Additional relevant MeSH terms:
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Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action