- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02648178
Evaluation of Appeal and Impact of E-Cigarettes Among Chronic Smokers With Smoking-Related Cancers
September 18, 2019 updated by: James D. Sargent, Dartmouth-Hitchcock Medical Center
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
19
Phase
- Not Applicable
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
-
-
New Hampshire
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Lebanon, New Hampshire, United States, 03756
- Dartmouth Hitchcock Medical Center
-
-
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 and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
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: Other
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: HALO G6
HALO cigalike model
|
HALO manufactures e-cigarettes which will be distributed to patients.
Two products, the G6 and tank model will be used.
|
Active Comparator: HALO Triton
HALO tank model
|
HALO manufactures e-cigarettes which will be distributed to patients.
Two products, the G6 and tank model will be used.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
12 Weeks
|
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
|
12 Weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: James D Sargent, MD, Dartmouth College
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 (Actual)
June 1, 2016
Primary Completion (Actual)
May 1, 2018
Study Completion (Actual)
May 1, 2018
Study Registration Dates
First Submitted
January 5, 2016
First Submitted That Met QC Criteria
January 5, 2016
First Posted (Estimate)
January 6, 2016
Study Record Updates
Last Update Posted (Actual)
September 19, 2019
Last Update Submitted That Met QC Criteria
September 18, 2019
Last Verified
September 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- D15154
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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