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What Are the Effects of Varenicline Compared With Nicotine Replacement Therapy on Long Term Smoking Cessation and Clinically Important Outcomes?

NCT02681848 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 180000

Last updated 2019-03-05

No results posted yet for this study

Summary

Introduction: Smoking is a major avoidable cause of ill-health and premature death. Treatments that help patients successfully quit smoking have an important effect on health and life expectancy. Varenicline is a medication that can help smokers successfully quit smoking. However, there are concerns that it may cause adverse effects, such as increase in the occurrence of depression, self-harm and suicide and cardiovascular disease. In this study the investigators aim to examine the effects of varenicline versus other smoking cessation pharmacotherapies on smoking cessation, health service use, all-cause and cause-specific mortality and physical and mental health conditions.

Methods: In this project the investigators will investigate the effects of varenicline compared to nicotine replacement therapies on: (1) long-term smoking cessation and whether these effects differ by area level deprivation; and (2) the following clinically-important outcomes: rate of general practice and hospital attendance; all-cause mortality and death due to diseases of the respiratory system and cardiovascular disease; and a primary care diagnosis of respiratory illness, myocardial infarction or depression and anxiety. The study is based on a cohort of patients prescribed these smoking cessation medications from the Clinical Practice Research Datalink (CPRD). The investigators will use three methods to overcome confounding: multivariable adjusted Cox regression, propensity score matched Cox regression, and instrumental variable regression. The total expected sample size for analysis will be at least 180 000. Follow-up will end with the earliest of either an 'event' or censoring due to the end of registration or death.

Ethics and dissemination: Ethics approval was not required for this study. This project has been approved by the CPRD's Independent Scientific Advisory Committee (ISAC). The investigators will disseminate the findings via publications in international peer-reviewed journals and presentations at international conferences.

Conditions

Interventions

DRUG

Varenicline

Smoking cessation medication

DRUG

Nicotine replacement therapy

Sponsors & Collaborators

  • University of Bristol

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-09-01
Primary Completion
2014-03-31
Completion
2019-09-30

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02681848 on ClinicalTrials.gov