N/A
N=103
Developing Genetic Education for Smoking Cessation
Tobacco Smoking
Bottom Line
View on ClinicalTrials.gov: NCT01186016 ↗Enrolled (actual)
103
Serious AEs
0.0%
Results posted
Dec 2022
Primary outcome: Primary: Knowledge of Genetic Contributions to Smoking — 5.25; 3.73; 7.04; 4.03 score on a scale — p=<0.01
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Genetic Education Session (Behavioral); Nutrition Education Session (Behavioral)
- Age
- Adult, Older Adult · 19+ yrs
- Sex
- All
- Sponsor
- University of Nebraska
- Primary completion
- Apr 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Knowledge of Genetic Contributions to Smoking |
5.25; 3.73; 7.04; 4.03 | <0.01 sig |
| PRIMARY Smoking-Related Appraisals |
3.93; 3.99; 3.80; 3.86; 2.73; 2.57 | 0.44 |
| PRIMARY Smoking Abstinence at End of Smoking Cessation Sessions |
11; 10; 17; 15 | .88 |
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
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01186016). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.