Developing Genetic Education for Smoking Cessation

NCT01186016 | Completed Results DMC

• 2 other identifiers: 0226-09-FB1R21DK084517-01
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

Brief 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:

• 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

Conditions

Tobacco Smoking

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Knowledge of Genetic Contributions to Smoking

  Knowledge of genetic contributions to smoking. Name of Scale: Genetic Knowledge Test (9 items). Minimum/Maximum Scores: 0-9. Higher score means better outcome.

  One week after completion of the two Educational Sessions (GES or NES). Educational sessions occurred over two weeks.

• Smoking-Related Appraisals

  Self-efficacy for Quitting/Resisting Smoking. Self-efficacy/Temptation Scale (Velicer, DiClemente, Rossi \& Prochaska, 1990) Total Score. Scores range from 1 to 5, with higher scores indicating greater self-efficacy. Source: Velicer, W.F., DiClemente, C.C., Rossi, J.S., \& Prochaska, J.O. (1990). Relapse situations and self-efficacy: An integrative model. Addictive Behaviors, 15, 271-283.

  Six weeks after the baseline data collection, which was the end of the Smoking Cession Sessions.

• Smoking Abstinence at End of Smoking Cessation Sessions

  Number of participants reporting Smoking Abstinence at the end of the Smoking Cessation Sessions and who had a carbon monoxide (CO) measurement of 6 ppm or less.

  Six weeks, which was the end of the Smoking Cessation Sessions.

Study Arms (2)

Genetic Education Session (GES)

EXPERIMENTAL

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. All participants also receive a 5-week standard cognitive-behavioral smoking cessation intervention with 6 weeks of OTC transdermal nicotine replacement therapy.

Behavioral: Genetic Education Session

Nutrition Education Session (NES)

ACTIVE COMPARATOR

The objective is to provide a control group that will received comparable attention as the experimental group by providing USDA approved nutritional information (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.

Behavioral: Nutrition Education Session

Interventions

Genetic Education Session BEHAVIORAL

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.

Also known as: GES

Genetic Education Session (GES)

Nutrition Education Session BEHAVIORAL

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.

Also known as: NES

Nutrition Education Session (NES)

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Current Smoker
• Smoking ten or more cigarettes per day
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Nebraska: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

Related Publications (24)

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MeSH Terms

Conditions

Tobacco Smoking; Smoking Cessation

Condition Hierarchy (Ancestors)

Smoking; Behavior; Tobacco Use; Health Behavior

Limitations and Caveats

Group sessions may have hindered attendance/study withdrawal. Of the 89 participants only 44 Experimental and 34 Control group participants received the GES or NES and 33 Experimental and 28 Control group participants completed the smoking cessation program. Future studies can determine if one session of GES/NES and individual smoking cessation sessions increases participation/retention.

Results Point of Contact

• Title: Julia F Houfek
• Organization: University of Nebraska Medical Center

jhoufek@unmc.edu

402-660-4046

Study Officials

• Julia F Houfek, PhD, RN

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2010
• First Posted: August 20, 2010
• Study Start: February 1, 2010
• Primary Completion: April 1, 2012
• Study Completion: July 1, 2012
• Last Updated: October 4, 2023
• Results First Posted: December 7, 2022

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ANALYTIC CODE
• Time Frame: After main study findings are published.
• Access Criteria: Researchers in the public or private sector studying genetic education for smoking cessation who contact the PI.

Locations

US (1)