Preloaded Combination Nicotine Replacement Therapy on Smoking Cessation of Adult Population in Kazakhstan

March 22, 2023 updated by: Chethan Purushothama, Nazarbayev University

Effectiveness of Preloaded Combination Nicotine Replacement Therapy on Smoking Cessation of Adult Population in Kazakhstan- A Randomized Controlled Trial

Randomized, controlled, two-armed, single-blinded, superiority trial with 1:1 allocation ratio Nicotine Replacement Therapy(NRT)

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The primary objective is to determine the effectiveness of preloaded combination nicotine replacement therapy (NRT) on smoking cessation of tobacco smokers. The secondary objectives are to determine the predictors of smoking cessation among the study participant's, to determine the change in health-related quality of life due to smoking cessation & to determine the perception of treatment adherence among the study participants.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Kazakhstan
      • Astana, Kazakhstan, 010000
        • Nazarbayev University School of Medicine
      • Astana, Kazakhstan, 010000
        • National Research Cardiac Surgery Center, Astana, Kazakhstan
        • Contact:
          • Chetan Purushothama

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • all current smokers aged 18 years and above with a motivation to quit

Exclusion Criteria:

  • smokeless tobacco users, smoking frequency of fewer than 10 cigarettes per day, pregnant women, lactating women, patients with a recent history of myocardial infarction of fewer than 3 months, and electronic cigarette users

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nicotine replacement therapy (NRT) Preloading
  1. Brief Advice (5 A's & 5 R's)- 0-day, Month- 1, 3, 6, 9, 12
  2. a. Nicotine Replacement Therapy for > 20 cigarettes per day

Nicotine Patch: Preloading for 4 weeks + 12 weeks post quit date,21 mg: 4 weeks before and after quit date,14 mg: Next 4 weeks,7 mg: Last 4 weeks Nicotine chewing gums 4 mg for 12 weeks post quit date (12/day on week 1(Tapering dose weekly)1/day on week 12

2.b. Nicotine Replacement Therapy for < 20 cigarettes per day Nicotine Patch: Preloading for 4 weeks + 12 weeks post quit date 21 mg: 4 weeks before and after quit date 14 mg: Next 4 weeks 7 mg: Last 4 weeks

Nicotine chewing gums 2 mg for 12 weeks post quit date (12/day on week

1(Tapering dose)1/day on week 12
Drug: Nicotine patch, Nicotine gums

Nicotine patch 21mg, 12 weeks post quit date and nicotine chewing gums 4mg for 12 weeks post quit date

  • 14 mg: Next 4 weeks
  • 7 mg: Last 4 weeks
Other Names:
  • Nicotex
Behavioral: Brief Advice (5 A's & 5 R's)
Brief Advice (5 A's & 5 R's) at Day 0, 1 month, 3,6,9 & 12 months
Drug: Nicotine Patch: Preloading for 4 weeks
Nicotine Patch: Preloading for 4 weeks - 21 mg: 4 weeks before quit date
Active Comparator: Nicotine replacement therapy (NRT)
  1. Brief Advice (5 A's & 5 R's)- 0-day, Month- 1, 3, 6, 9, 12
  2. a. Nicotine Replacement Therapy for > 20 cigarettes per day

Nicotine Patch: 12 weeks post quit date 21 mg: 4 weeks after quit date 14 mg: Next 4 weeks 7 mg: Last 4 weeks

Nicotine chewing gums 4 mg for 12 weeks post quit date (12/day on week 1(Tapering dose weekly)1/day on week 12

2.b. Nicotine Replacement Therapy for < 20 cigarettes per day

Nicotine Patch: 12 weeks post quit date 21 mg: 4 weeks after quit date 14 mg: Next 4 weeks 7 mg: Last 4 weeks

Nicotine chewing gums 2 mg for 12 weeks post quit date (12/day on week 1(Tapering dose)1/day on week 12
Drug: Nicotine patch, Nicotine gums

Nicotine patch 21mg, 12 weeks post quit date and nicotine chewing gums 4mg for 12 weeks post quit date

  • 14 mg: Next 4 weeks
  • 7 mg: Last 4 weeks
Other Names:
  • Nicotex
Behavioral: Brief Advice (5 A's & 5 R's)
Brief Advice (5 A's & 5 R's) at Day 0, 1 month, 3,6,9 & 12 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self reported smoking during intervention period : Yes/No
Time Frame: Assessed at 12 months from the starting point of intervention.
Self-reported smoking anytime during the intervention or follow-up period
Assessed at 12 months from the starting point of intervention.
Salivary cotinine test results: Positive or Negative
Time Frame: Salivary cotinine test results before intervention, after the intervention and after follow ups
Salivary cotinine test results before, during and after the intervention
Salivary cotinine test results before intervention, after the intervention and after follow ups

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self reported number of quit attempts of tobacco
Time Frame: Assessed at 3, 6 & 12 months from the starting point of intervention.
Number of quit attempts of tobacco since enrolment
Assessed at 3, 6 & 12 months from the starting point of intervention.
Self reported number of smoked cigarettes/bidis per day
Time Frame: Assessed at 12 months from the starting point of intervention.
Number of smoked cigarettes/bidis per day since enrolment
Assessed at 12 months from the starting point of intervention.
Adherence to intervention in days: Self reported
Time Frame: Assessed at 12 months from the starting point of intervention.
Self reported duration of use of the intervention in days
Assessed at 12 months from the starting point of intervention.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pattern of smoking
Time Frame: Assessed at 12 months from the starting point of intervention.
The change in smoking frequency from the baseline information (It can be excess use, reduced use or relapse)
Assessed at 12 months from the starting point of intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nazarbayev University

Collaborators

Astana Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 1, 2023

Primary Completion (Anticipated)

December 31, 2024

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

July 22, 2022

First Submitted That Met QC Criteria

July 30, 2022

First Posted (Actual)

August 2, 2022

Study Record Updates

Last Update Posted (Actual)

March 24, 2023

Last Update Submitted That Met QC Criteria

March 22, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11022021CRP1514

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data of the current study will available from the corresponding author on reasonable request.

IPD Sharing Time Frame

Data will be available from the corresponding author on reasonable request.

IPD Sharing Access Criteria

Data will be available from the corresponding author on reasonable request via e-mail

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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