Developing Genetic Education for Smoking Cessation - Full Text View

Purpose

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	Intervention
Tobacco Smoking	Behavioral: Genetic Education Session Behavioral: Nutrition Education Session

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Developing Genetic Education for Smoking Cessation

Resource links provided by NLM:

MedlinePlus related topics: Quitting Smoking Smoking

U.S. FDA Resources

Further study details as provided by University of Nebraska:

Primary Outcome Measures:

Mental representations when experimental and attention control groups are compared. [ Time Frame: 6 months after the end of the Smoking Cessation Intervention ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Use of cessation strategies, abstinence, and interest in genotyping.

Secondary Outcome Measures:

Differences in mental representations based on personality characteristics and education level. [ Time Frame: 6 months after the end of the Smoking Cessation Intervention ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
State negative affect and intrusive/avoidant thoughts.

Enrollment:	103
Study Start Date:	February 2010
Study Completion Date:	July 2012
Primary Completion Date:	April 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Arms

Assigned Interventions

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

Show Detailed Description

Eligibility

Ages Eligible for Study:	19 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Current Smoker
Smoking ten or more cigarettes per day
19 years or older
Intention of quitting smoking in the next month
Agree to use two forms of acceptable birth control while using the nicotine replacement patch

Exclusion Criteria:

Not currently seeking treatment for a mental disorder with psychotic symptoms
Not currently pregnant nor nursing
Not been recently diagnosed or currently affected with cancer or any other life-threatening illness
No recent heart attack
No history of high blood pressure or not currently receiving treatment to manage high blood pressure
No history of an irregular heartbeat
Not currently taking medications to help quit smoking (i.e. Chantix, Zyban or Wellbutrin, NRT)
No history of adverse effects from using nicotine replacement patches
Not currently experiencing serious pain or discomfort due to heart disease

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01186016

Locations

United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198

Sponsors and Collaborators

University of Nebraska

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

Investigators

Principal Investigator:

Julia F Houfek, PhD, RN

University of Nebraska

More Information

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Collins FS, Green ED, Guttmacher AE, Guyer MS; US National Human Genome Research Institute. A vision for the future of genomics research. Nature. 2003 Apr 24;422(6934):835-47. Epub 2003 Apr 14. No abstract available.

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Brownlee, S., Leventhal, H., & Leventhal, E. A. (2000). Regulation, self-regulation, and construction of the self in maintenance of physical health. In M. Boekaerts, P.R. Pintrich, & M. Zeidner, (Eds.). Handbook of Self-Regulation. San Diego, CA: Academic Press, pp. 369-416.

2008 PHS Guideline Update Panel, Liaisons, and Staff. Treating tobacco use and dependence: 2008 update U.S. Public Health Service Clinical Practice Guideline executive summary. Respir Care. 2008 Sep;53(9):1217-22. No abstract available.

Lerman, C.E., Schnoll, R.A., & Munafo, M.R. (2007). Genetics and smoking cessation. American Journal of Preventive Medicine, 33 (6S), S398-S405.

Li MD, Ma JZ, Beuten J. Progress in searching for susceptibility loci and genes for smoking-related behaviour. Clin Genet. 2004 Nov;66(5):382-92. Review.

Li MD, Cheng R, Ma JZ, Swan GE. A meta-analysis of estimated genetic and environmental effects on smoking behavior in male and female adult twins. Addiction. 2003 Jan;98(1):23-31. Review.

Liang, K.Y., & Zeger, S.L. (1986). Longitudinal data analysis using generalized linear models. Biometrika, 73, 13-22.

Swan GE, Hudmon KS, Jack LM, Hemberger K, Carmelli D, Khroyan TV, Ring HZ, Hops H, Andrews JA, Tildesley E, McBride D, Benowitz N, Webster C, Wilhelmsen KC, Feiler HS, Koenig B, Caron L, Illes J, Cheng LS. Environmental and genetic determinants of tobacco use: methodology for a multidisciplinary, longitudinal family-based investigation. Cancer Epidemiol Biomarkers Prev. 2003 Oct;12(10):994-1005.

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Sullivan, P. F., & Kendler, K. S. (1999). The genetic epidemiology of smoking. Nicotine & Tobacco Research, 1(Supplement 2), 549-555.

Shields A, Lerman C, Sullivan P. Translating emerging research on the genetics of smoking into clinical practice: ethical and social considerations. Nicotine Tob Res. 2004 Aug;6(4):675-88. Review.

McInerney J. Education in a genomic world. J Med Philos. 2002 Jun;27(3):369-90.

Messina ES, Tyndale RF, Sellers EM. A major role for CYP2A6 in nicotine C-oxidation by human liver microsomes. J Pharmacol Exp Ther. 1997 Sep;282(3):1608-14.

Morgan GD, Kobus K, Gerlach KK, Neighbors C, Lerman C, Abrams DB, Rimer BK. Facilitating transdisciplinary research: the experience of the transdisciplinary tobacco use research centers. Nicotine Tob Res. 2003 Dec;5 Suppl 1:S11-9.

Schnoll RA, Johnson TA, Lerman C. Genetics and smoking behavior. Curr Psychiatry Rep. 2007 Oct;9(5):349-57. Review.

Responsible Party:	Julia Houfek, PhD, Professor, PhD, APRN-CNS, University of Nebraska
ClinicalTrials.gov Identifier:	NCT01186016 History of Changes
Other Study ID Numbers:	226-09-FB, 1R21DK084517-01
Study First Received:	July 22, 2010
Last Updated:	January 17, 2013
Health Authority:	United States: Federal Government United States: Institutional Review Board

Keywords provided by University of Nebraska:

Genetic Education
Smoking Cessation
Quitting Smoking
Standard Smoking Cessation Program
Genetic Education for Smoking Cessation

Additional relevant MeSH terms:

Smoking
Habits

ClinicalTrials.gov processed this record on May 23, 2013