Skip to main content
OpenTrials
Completed

NCT Number: NCT02648178

Evaluation of Appeal and Impact of E-Cigarettes Among Chronic Smokers With Smoking-Related Cancers

This study will test feasibility, in smokers with lung, head & neck, and bladder cancers, that examines the effect of e-cigarette substitution, on measures of smoking-related toxicity and medical outcomes. The aim of the study is to determine the appeal of e-cigarettes compared to regular combustible cigarettes.

Completed

Looking for future studies?

Notify Me

Key information

About this study

The aim of the study is to determine the appeal of e-cigarettes compared to combustible cigarettes as measured by the degree to which patients succeed in reducing their cigarette consumption over the 9 weeks they are supplied with product, along with their consumption of e-cigarettes. We will measure past use of e-cigarettes and cigarettes at baseline, 3, 6, 9, and 12 weeks. We will also assess the effect of e-cigarette substitution on toxicity by measuring expired carbon monoxide and urine NNAL (4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol) , a carcinogenic metabolite of cigarette smoke.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histological or cytological diagnosis of lung, head & neck, or bladder cancer within the past 5 years.
  • AJCC (American Joint Committee on Cancer) stages I-IV
  • Daily Smoking (at least 10 cigarettes per day for 10 years) and breath CO (carbon monoxide) greater than or equal to 9 ppm
  • Does not wish to quit smoking now (anyone wishing to quit smoking will be referred for smoking cessation counselling through the DHMC (Dartmouth Hitchcock Medical Center) program)
  • May be receiving anti-cancer agents
  • Age 18 or older
  • Fluent in English;
  • Patient must be capable and willing to provide informed written consent for study participation;
  • Able to participate in study visits

Exclusion criteria

  • Cancer surgery planned in the next 9 weeks;
  • Treatment with radiation planned for the next 9 weeks,
  • Actively trying to quit smoking, or planning to in the next 30 days. (If a subject reports that they plan to quit smoking in the next 30 days, we will call them after the 30 days to see if they are still trying to quit.)
  • Any use of e-cigarettes in the past 30 days,
  • Pregnant or trying to get pregnant.

Treatment and study plan

HALO

Device

HALO manufactures e-cigarettes which will be distributed to patients. Two products, the G6 and tank model will be used.

Primary outcomes

  1. Change in Daily Cigarette Smoking Given 10 or More E-cigarette Sessions in a Day

    Time frame: 12 Weeks

    Participants report of daily cigarette and e-cigarette use for the previous 7 days at each study time-point (baseline and 3, 6, 9, and 12 weeks post-baseline) will be averaged to create usual daily cigarette. Mixed-effects linear regression with a random effect at the participant level will be used to assess the association between usual cigarette use (dependent variable) and usually e-cigarette use (independent predictor) over the study period while accounting for the repeated measures within subject. The model will be fit using restricted maximum likelihood. Time will be included in the model as continuous and categorical, separately, and we assess for stability of the association between cigarette use and e-cigarette over time by including an interaction term between e-cigarette use and time in the model.

  2. Average Number of E-cigarettes Used Per Day

    Time frame: 12 Weeks

    Average number of e-cigarettes used per day over the 12 week period

Sponsors and collaborators

Lead sponsor

Dartmouth-Hitchcock Medical Center

Other

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jan 6, 2016
Registry last updated
Sep 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.