NCT02922790

Feasibility and Smokers' Reactions to DNA Feedback

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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).

Conditions

• Smoking

Interventions

Type	Name	Description
BEHAVIORAL	standard health information	Subjects will review standard health information
BEHAVIORAL	standard health information plus info. on DNA damage	Subjects will review standard health information and information on DNA damage
BEHAVIORAL	Subjects will review standard health information and information on DNA damage, plus pictures of their DNA damage	Subjects will review standard health information and information on DNA damage, as well as review pictures of their cells' DNA damage

Timeline

• Start date: 2017-02-14
• Primary completion: 2017-07-24
• Completion: 2017-07-24
• First posted: 2016-10-04
• Last updated: 2018-01-05

Locations

1 site across 1 country: United States