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NCT01186016

Developing Genetic Education for Smoking Cessation

Completed NA Results posted Last updated 4 October 2023
What this trial tests

NA trial testing Genetic Education Session in Tobacco Smoking in 103 participants. Completed in 1 July 2012.

Timeline
1 February 2010
Primary endpoint
1 April 2012
1 July 2012

Quick facts

Lead sponsorUniversity of Nebraska
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment103
Start date1 February 2010
Primary completion1 April 2012
Estimated completion1 July 2012
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of Nebraska

Who can join

19 and older, any sex, with Tobacco Smoking. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Knowledge of Genetic Contributions to Smoking Primary · One week after completion of the two Educational Sessions (GES or NES). Educational sessions occurred over two weeks.

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

Baseline
GroupValue95% CI
Genetic Education Session (GES)5.25± 2.55
Nutrition Education Session (NES)3.73± 2.66
End of Educational Sessions
GroupValue95% CI
Genetic Education Session (GES)7.04± 1.72
Nutrition Education Session (NES)4.03± 2.78
Smoking-Related Appraisals Primary · Six weeks after the baseline data collection, which was the end of the Smoking Cession Sessions.

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.

Baseline
GroupValue95% CI
Genetic Education Session (GES)3.93± .46
Nutrition Education Session (NES)3.99± .70
End of Educational Sessions
GroupValue95% CI
Genetic Education Session (GES)3.80± .60
Nutrition Education Session (NES)3.86± .69
End of Smoking Cessation Sessions
GroupValue95% CI
Genetic Education Session (GES)2.73± .86
Nutrition Education Session (NES)2.57± 1.03
Smoking Abstinence at End of Smoking Cessation Sessions Primary · Six weeks, which was the end of the 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.

GroupValue95% CI
Genetic Education Session (GES)11
Nutrition Education Session (NES)10
Genetic Education Session (GES)17
Nutrition Education Session (NES)15

Sponsor's own description

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

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Additional behavioural support as an adjunct to pharmacotherapy for smoking cessation.
    Hartmann-Boyce J, Hong B, Livingstone-Banks J, Wheat H, et al · · 2019 · cited 108× · PMID 31166007 · DOI 10.1002/14651858.cd009670.pub4
  2. Biomedical risk assessment as an aid for smoking cessation.
    Clair C, Mueller Y, Livingstone-Banks J, Burnand B, et al · · 2019 · cited 20× · PMID 30912847 · DOI 10.1002/14651858.cd004705.pub5

Verify or expand the search:

Other recruiting trials for Tobacco Smoking

Currently open trials in the same condition.

Other University of Nebraska trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01186016.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing