Developing Genetic Education for Smoking Cessation

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Julia Houfek, PhD, University of Nebraska
ClinicalTrials.gov Identifier:
NCT01186016
First received: July 22, 2010
Last updated: January 17, 2013
Last verified: January 2013
  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:

  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

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:


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

  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
Investigators
Principal Investigator: Julia F Houfek, PhD, RN University of Nebraska
  More Information

Publications:
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.
Lerman, C.E., Schnoll, R.A., & Munafo, M.R. (2007). Genetics and smoking cessation. American Journal of Preventive Medicine, 33 (6S), S398-S405.
Liang, K.Y., & Zeger, S.L. (1986). Longitudinal data analysis using generalized linear models. Biometrika, 73, 13-22.
Sutherland, B.A. (2003). Evidence for counseling effectiveness for smoking cessation. Journal of Clinical Psychiatry Monograph, 18, 22-34.
Sullivan, P. F., & Kendler, K. S. (1999). The genetic epidemiology of smoking. Nicotine & Tobacco Research, 1(Supplement 2), 549-555.

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 April 17, 2014