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Biomarker Feedback for Smoking Cessation

Biomarker Feedback for Smoking Cessation

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02206971
Enrollment
109
Registered
2014-08-01
Start date
2012-05-31
Completion date
2014-12-31
Last updated
2020-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cigarette Smoking

Brief summary

The purpose of this study is to examine the impact of providing light smokers with feedback about their health, including exposure to tobacco-related chemicals.

Detailed description

The smoking pattern among adults in the US is undergoing a remarkable change. A substantial proportion of smokers are now light smokers (smoke ≤ 10 cigarettes per day), yet little is known about how to help light smokers quit. The prevalence of light smoking is high (\ 50%) among African Americans (AAs) who compared to other groups have high cotinine levels, are less successful quitting smoking, and experience disproportionately higher smoking-related cancers. Because light smokers often think that smoking fewer cigarettes a day is safe, a potential smoking cessation strategy is therefore to provide light smokers with feedback on biomarkers of tobacco exposure and increased cancer risk. The objective of this proposal is to develop and pilot test a biomarker risk assessment intervention to enhance smoking cessation for AA light smokers. The proposal builds on our previous work that shows that light smokers have 1) difficulty quitting smoking, 2) lower perceived health risks, but high levels of biomarkers (e.g. cotinine). This study will occur in 2 phases. Phase 1 will utilize focus groups to examine prevailing knowledge, attitudes, and beliefs about biomarkers as well as preferences about how participants would like to receive biomarker feedback (BF; e.g. by mail, phone, in-person). In Phase 2, data from the focus groups will be used to develop a (BF) intervention for light smokers. The new intervention will undergo further feasibility evaluation among 60 adult light smokers. Outcomes in Phase 2 will include process measures, (e.g. perceived usefulness, acceptance, and adherence) and changes in biomarker values with smoking reduction or cessation. By the end of the proposed pilot study, we expect to have developed a replicable, feasible, and acceptable BF intervention that will be ready for efficacy testing in a large clinical trial for smoking cessation or smoking reduction. The aims of the application are to: 1) Examine the prevailing knowledge, attitudes, beliefs, and preferences about BF for smoking cessation among AA light smokers; 2) Develop a BF intervention for smoking cessation among AA light smokers; and 3) Test the feasibility of a BF intervention for smoking cessation in AA light smokers.

Interventions

OTHERurine analyses feedback

biomarker feedback report regarding the urine sample analyzed for the tobacco chemicals, cotinine, nicotine and NNAL

Sponsors

Masonic Cancer Center, University of Minnesota
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes

Inclusion criteria

* Male or female cigarette smokers, 18-75 years * Smoked an average of less than 10 cigarettes per day during past month * A personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.

Exclusion criteria

* Only one subject per household may participate * Pregnancy

Design outcomes

Primary

MeasureTime frameDescription
urinary cotinine levelweek 0, week 8, week 26changes to biomarker levels with smoking reduction or cessation

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026