Developing Genetic Education for Smoking Cessation

NCT01186016 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 103

Last updated 2023-10-04

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Summary

This study will test the effects of an educational program about genetics and smoking on smokers' thoughts, feelings, and behaviors before and after participating in smoking cessation treatment. This includes describing participants' knowledge about genetics and smoking, their use of strategies to stop smoking, and experiences when quitting smoking. This study will determine how smokers respond to information about genetics and smoking in anticipation of using genetic information to individualize pharmacological therapy for smoking cessation.

Two groups will participate in this study. The experimental group will participate in two educational sessions about genetics and smoking. The control group will participate in two educational sessions about nutrition. Both the experimental and control groups will participate in a standard, group smoking cessation program with 6 weeks of over-the-counter (OTC) transdermal nicotine replacement therapy. Assignment to either of the two groups is random.

The primary specific aim is to compare the effects of the experimental group to the attention control group on smoking-related mental representations, appraisals, behaviors, and affective responses over time. The secondary aim is to explore whether personality characteristics (trait negative affectivity and curiosity) and educational level moderate the effects of the genetic educational program on smoking-related mental representations, appraisals, behaviors, and affective responses. The hypotheses of the study are as follows:

1. When compared to the attention control group, the experimental group will demonstrate:

* Smoking-Related Mental Representations:
* Greater knowledge of genetic contributions to smoking
* Greater endorsement of genetic contributions to smoking
* More positive attitudes towards NRT
* Increased abstainer and decreased smoker self-schemas
* Smoking-Related Appraisal: greater perceived risk for genetic predispositions to smoking
* Smoking-Related Behaviors: greater interest in genotyping.
2. When compared to the attention control group, the experimental group will differ in:

* Smoking-Related Appraisals: self-efficacy for cessation and abstinence
* Smoking-Related Behaviors: number of quit attempts, abstinence, nicotine dependence
* Affective Responses: negative affect and intrusive/avoidant thoughts

Conditions

  • Tobacco Smoking

Interventions

BEHAVIORAL

Genetic Education Session

The intervention includes receiving education about genetics and smoking. The content is basic genetics and education about the multifactorial nature of smoking; research findings about genetic contributions to smoking, potential applications of this research for cessation treatment, and legal, ethical and social implications of future use of genotyping for cessation. All participants also receive a 5-week standard cognitive-behavioral smoking cessation intervention with 6 weeks of OTC transdermal nicotine replacement therapy.

BEHAVIORAL

Nutrition Education Session

To control for an attention placebo effect, the control group will receive information about nutritional guidelines as established by the USDA and the FDA. The attention control group will be referred to as the Nutritional Education Session (NES) group. The content of NES sessions one and two are use of the USDA (MyPyramid) dietary and food safety guidelines. All participants also receive a 5-week standard cognitive-behavioral smoking cessation intervention with 6 weeks of OTC transdermal nicotine replacement therapy.

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH
  • University of Nebraska

    lead OTHER

Principal Investigators

  • Julia F Houfek, PhD, RN · University of Nebraska

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-02-01
Primary Completion
2012-04-01
Completion
2012-07-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01186016 on ClinicalTrials.gov