Smokers' Response to Nicotine Dependence Genotyping

January 30, 2018 updated by: Julia Houfek, PhD, University of Nebraska
Innovative strategies to reduce adult smoking prevalence include using genetic information to motivate cessation and, ultimately, to tailor cessation pharmacotherapy. Success of these interventions depends, in part, on smokers' interest and participation in genetic testing related to cessation and their understanding and use of the results (i.e., their genetic literacy). The recent availability of genetic risk testing for a nicotinic acetylcholine receptor gene (CHRNA3) variant (rs105173) associated with nicotine dependence makes it highly feasible to investigate smokers' interest in and use of genetic information about nicotine dependence. Therefore, the primary purpose of this study is to determine the impact of an intervention that provides smokers with an educational session about genetic contributions to smoking and nicotine dependence plus their genotype results for rs1051730 on smoking cessation outcomes compared to those who receive only the educational session. Secondary purposes are to determine: (a) the impact of genetic education and knowing personal genotype results on genetic literacy outcomes and (b) the feasibility of recruitment and retention methods in a study addressing genotyping for nicotine dependence. Primary outcomes are cessation-related behaviors and cognitions indicating abstinence. Secondary outcomes are cognitions and emotions indicating genetic literacy. Knowledge gained from this study has the potential for clinical translation so that as genotyping becomes part of smoking cessation, health-care providers can understand and address factors influencing smokers' adaptation to genetically-informed cessation treatment. The study will use a longitudinal, repeated measures design (experimental, control; N=90; 45/group). All participants will receive a 90-minute educational session about genetic contributions for smoking and nicotine dependence and will donate a buccal swab sample for genotyping. The investigators will then randomize participants to two groups: those who receive genotyping results in a genetic counseling session (experimental) and those who do not (control). Follow-up data will be collected from both groups at baseline and weeks 2, 6, 10 after the experimental group receives genotyping results, with a brief follow-up and study termination occurring at week 12. Control group participants will be offered their genotyping results at the end of the study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The primary aim of this study is:

Aim 1. Determine the impact of knowing personal genotyping results for nicotine dependence risk on the smoking cessation (primary) outcomes at weeks 2, 6, and 10.

The working hypotheses for the cessation-related behaviors are:

  1. When compared to the control group, the experimental group will have greater: (1) smoking abstinence; (2) use of formal smoking cessation programs; (3) contact with health-care provider for cessation; (4) use of pharmacotherapy, and (5) use of self-management strategies for cessation.
  2. There will be no difference in the number of quit attempts between the experimental and control groups.

The working hypotheses for the cessation-related cognitions are:

  1. When compared to the control group, the experimental group will have higher self-efficacy for smoking cessation.
  2. When compared to the control group, the experimental group will have higher abstainer and lower smoker self-schemas.

The secondary aims are:

Aim 2. Determine the impact of knowing personal genotyping results for nicotine dependence risk on the secondary genetic literacy (secondary) outcomes at weeks 2, 6, and 10.

The working hypotheses for the genetic literacy-related cognitions and emotions are:

  1. When compared to the control group, the experimental group will have greater: (1) knowledge of genetic contributions to smoking, (2) mental representations indicating endorsement of genetic risk for nicotine dependence, (3) accurate perceptions of genetic risk for nicotine dependence, and (4) self-efficacy for use of genotyping results.
  2. There will be no difference in psychological distress between the experimental and control groups.

Aim 3. Explore smokers' perceptions and experiences that contextualize participation in genetic education and genotyping for nicotine dependence risk. We will conduct focus groups with both the intervention and control group participants at weeks 2 and 6 after intervention group participants receive their genotyping results.

Aim 4. Determine the feasibility of an intervention that informs people of their personal genotype results for nicotine dependence risk for a larger clinical trial, including evaluation of enrollment (recruitment efficiency, attrition, problems and solutions), intervention fidelity (delivery, receipt, enactment), data collection, subject acceptability of the intervention, and estimation of effect sizes for sample size determination in future, larger clinical trials.

Study Type

Interventional

Enrollment (Actual)

24

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

  • United States
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • University of Nebraska 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

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • >19 years of age;
  • smoking>= 10 cigarettes/day;
  • intention to quit smoking at some time in the future;
  • able to understand, speak, and write in English, and
  • physically and mentally able to participate.

The investigators are excluding participants who do not understand, speak or write in English at this time because: (1) the consent document, the educational genetics presentation, and data collection forms are currently written in English only and (2)the resources to make the educational presentation and data collection documents culturally-specific for other cultures are not available. In making the study relevant for non-English speaking participants, it is not only a literal translation the presentation and documents into another language that is needed, but the ideas of health and heredity from the culture related to the language also need to be taken into account when presenting the study and the study materials in another language.

Exclusion Criteria:

  • current treatment for a mental disorder with psychotic symptoms;
  • diagnosis of cancer (other than basal or squamous cell skin cancer) or other life-threatening illness;
  • pregnant, or
  • currently enrolled in another smoking research study.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Receipt of Genetic Results
Receipt of Genetic Results indicates that participants have received the results of genotyping for RS1051730
Behavioral: Receipt of Genetic Results
Participants will receive the results of genotyping for RS1051730
Active Comparator: No results given
Participants will not be offered to receive the results of genotyping for RS1051730 until all data collection has been completed.
Behavioral: No results given
Participants will not be offered to receive the results of genotyping for RS1051730 until all data collection has been completed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Baseline Smoking Abstinence at 2, 6, and 10 Weeks after Genotyping Results
Time Frame: Weeks 2, 6, and 10 after genotyping results
Abstinence: Point-Prevalence & Continuous Self-Report; Exhaled CO: <= 6 ppm past 24 hrs.; Salivary Cotinine: <15 ng/ml past 7 days
Weeks 2, 6, and 10 after genotyping results

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Baseline Use of Pharmacotherapy at 2, 6, and 10 Weeks after Genotyping Results
Time Frame: 2, 6, and 10 weeks after genotyping results
Use of Pharmacotherapy: Self-report of type and frequency of use of FDA-approved smoking cessation medications. Verification of product at data collection.
2, 6, and 10 weeks after genotyping results

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Baseline Knowledge of Genetic Contributions to Smoking at 2, 6, and 10 Weeks after Genotyping Results
Time Frame: 2, 6, and 10 weeks after genotyping results
Knowledge Test of Genetics & Smoking Investigator Developed. 20 items; correct items are summed. Scores 0-20. Higher scores indicate more knowledge.
2, 6, and 10 weeks after genotyping results

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Nebraska

Collaborators

Department of Health and Human Services

Investigators

  • Principal Investigator: Julia F Houfek, PhD, University of Nebraska

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

November 14, 2012

Primary Completion (Actual)

August 31, 2013

Study Completion (Actual)

August 31, 2013

Study Registration Dates

First Submitted

January 25, 2013

First Submitted That Met QC Criteria

January 28, 2013

First Posted (Estimate)

January 30, 2013

Study Record Updates

Last Update Posted (Actual)

February 1, 2018

Last Update Submitted That Met QC Criteria

January 30, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 069-12-FB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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