Feasibility and Smokers' Reactions to DNA Feedback



Status:Completed
Conditions:Smoking Cessation
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - Any
Updated:1/7/2018
Start Date:February 14, 2017
End Date:July 24, 2017

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The purpose of the study is to explore how feedback of cellular DNA (Deoxyribonucleic Acid)
damage, as a marker of exposure to the genotoxic agents of tobacco smoke, promotes cessation.

The study aims to recruit 50 smokers who are not engaged in quitting. The study will involve
two in-person visits. During visit 1, participants will complete a baseline survey and have
their blood drawn. Approximately two weeks later, in visit 2, smokers will be randomized in a
1:2:2 ratio to one of three arms:

1. education about harms of smoking (control group);

2. same education plus information on DNA damage and biomarker feedback (biomarker arm)
without visual of damage; or

3. same as arm 2 except accompanied with visuals of participants' normal and DNA damage
cells. Participants in the this arm will be informed of their proportion of leucocytes
showing DNA damage with pictures of their normal and damaged cells.

The goal of the analyses is to obtain effect size estimates (direction, confidence intervals)
to inform if results align with hypotheses and obtain insights about reactions about the
feedback (Aim 1). The study will collect feasibility data from baseline to three months
(e.g., percentage who show up to the sessions, attrition).

Inclusion Criteria:

- ages 18+

- smoke > 5 cig/day during the last week

- be open to biomarker feedback

- not actively trying to quit

Exclusion Criteria:

- smoker carbon monoxide level(CO < 10 ppm)
We found this trial at
1
site
2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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