Developing Genetic Education for Smoking Cessation
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|ClinicalTrials.gov Identifier: NCT01186016|
Recruitment Status : Completed
First Posted : August 20, 2010
Last Update Posted : January 21, 2013
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 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:
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.
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
|Condition or disease||Intervention/treatment||Phase|
|Tobacco Smoking||Behavioral: Genetic Education Session Behavioral: Nutrition Education Session||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||103 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Developing Genetic Education for Smoking Cessation|
|Study Start Date :||February 2010|
|Actual Primary Completion Date :||April 2012|
|Actual Study Completion Date :||July 2012|
Experimental: Genetic Education Session (GES)
The objectives are to: discuss the impact of the human genome project; define basic genetic concepts and terminology; distinguish between single-gene and multifactorial genetic diseases/conditions; describe genetic counseling/testing; identify uses of pharmacogenetics; discuss psychological and legal/ethical implications of genetic discoveries; smoking as a multifactorial behavior; findings of epidemiological studies about smoking heritability; research about candidate genotypes DRD2 and CYP2A6; and potential use of genotyping to tailor smoking cessation treatment.
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.
Other Name: GES
|Active Comparator: Nutrition Education Session (NES)||
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.
Other Name: NES
- Mental representations when experimental and attention control groups are compared. [ Time Frame: 6 months after the end of the Smoking Cessation Intervention ]Knowledge of genetic contributions to smoking, endorsement of genetic contributions to smoking, and attitudes towards nicotine replacement therapy [NRT].
- Appraisals when experimental and attention control groups are compared. [ Time Frame: 6 months after the end of the Smoking Cessation Intervention ]Perceived risk for genetic predisposition to smoking, and self-efficacy for cessation and abstinence.
- Smoking-related behavior when experimental and attention control groups are compared. [ Time Frame: 6 months after the end of the Smoking Cessation Intervention ]Use of cessation strategies, abstinence, and interest in genotyping.
- Differences in mental representations based on personality characteristics and education level. [ Time Frame: 6 months after the end of the Smoking Cessation Intervention ]Smoker and abstainer self-schemas.
- Differences in smoking-related behaviors based on personality characteristics and education level. [ Time Frame: 6 months after the end of the Smoking Cessation Intervention ]Number of quit attempts and nicotine dependence.
- Differences in affective responses based on personality characteristics and education level. [ Time Frame: 6 months after the end of the Smoking Cessation Intervention ]State negative affect and intrusive/avoidant thoughts.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01186016
|United States, Nebraska|
|University of Nebraska Medical Center|
|Omaha, Nebraska, United States, 68198|
|Principal Investigator:||Julia F Houfek, PhD, RN||University of Nebraska|