Trial Outcomes & Findings for Developing Genetic Education for Smoking Cessation (NCT NCT01186016)
NCT ID: NCT01186016
Last Updated: 2023-10-04
Results Overview
Knowledge of genetic contributions to smoking. Name of Scale: Genetic Knowledge Test (9 items). Minimum/Maximum Scores: 0-9. Higher score means better outcome.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
103 participants
Primary outcome timeframe
One week after completion of the two Educational Sessions (GES or NES). Educational sessions occurred over two weeks.
Results posted on
2023-10-04
Participant Flow
We had 103 participants in the study. The last 14 participants were recruited at the end of the funding period and had a shortened intervention and data collection protocol to determine feasibility of the shortened protocol. The main study variables were analyzed on 89 participants (50 in the experimental GES group; 39 in the attentional control NES group) who completed the original protocol.
Participant milestones
| Measure |
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 dopamine D2 receptor (DRD2) and CYP2A6; and potential use of genotyping to tailor smoking cessation treatment.
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 over-the-counter (OTC) transdermal nicotine replacement therapy.
|
Nutrition Education Session (NES)
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 U.S. Department of Agriculture (USDA) (MyPyramid) dietary and food safety guidelines. All participants also receive a 5-week standard cognitive-behavioral smoking cessation intervention with 6 weeks of over-the-counter (OTC) transdermal nicotine replacement therapy.
|
|---|---|---|
|
Overall Study
STARTED
|
57
|
46
|
|
Overall Study
Started Original Protocol
|
50
|
39
|
|
Overall Study
Completed Original Protocol
|
10
|
12
|
|
Overall Study
COMPLETED
|
11
|
17
|
|
Overall Study
NOT COMPLETED
|
46
|
29
|
Reasons for withdrawal
| Measure |
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 dopamine D2 receptor (DRD2) and CYP2A6; and potential use of genotyping to tailor smoking cessation treatment.
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 over-the-counter (OTC) transdermal nicotine replacement therapy.
|
Nutrition Education Session (NES)
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 U.S. Department of Agriculture (USDA) (MyPyramid) dietary and food safety guidelines. All participants also receive a 5-week standard cognitive-behavioral smoking cessation intervention with 6 weeks of over-the-counter (OTC) transdermal nicotine replacement therapy.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
46
|
29
|
Baseline Characteristics
Developing Genetic Education for Smoking Cessation
Baseline characteristics by cohort
| Measure |
Genetic Education Session (GES)
n=57 Participants
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.
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.
|
Nutrition Education Session (NES)
n=46 Participants
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.
|
Total
n=103 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
54 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
51 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
57 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
103 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: One week after completion of the two Educational Sessions (GES or NES). Educational sessions occurred over two weeks.Population: Analysis is based on the number of participants who completed the two educational sessions, i.e., GES for the experimental group and NES for the attentional control group.
Knowledge of genetic contributions to smoking. Name of Scale: Genetic Knowledge Test (9 items). Minimum/Maximum Scores: 0-9. Higher score means better outcome.
Outcome measures
| Measure |
Genetic Education Session (GES)
n=44 Participants
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.
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.
|
Nutrition Education Session (NES)
n=33 Participants
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.
|
|---|---|---|
|
Knowledge of Genetic Contributions to Smoking
End of Educational Sessions
|
7.04 score on a scale
Standard Deviation 1.72
|
4.03 score on a scale
Standard Deviation 2.78
|
|
Knowledge of Genetic Contributions to Smoking
Baseline
|
5.25 score on a scale
Standard Deviation 2.55
|
3.73 score on a scale
Standard Deviation 2.66
|
PRIMARY outcome
Timeframe: Six weeks after the baseline data collection, which was the end of the Smoking Cession Sessions.Population: Analysis is based on the number of participants who completed the Smoking Cessation Sessions and returned questionnaire data for the following time points: baseline, end of the Educational Sessions, and end of the Smoking Cessation 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.
Outcome measures
| Measure |
Genetic Education Session (GES)
n=28 Participants
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.
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.
|
Nutrition Education Session (NES)
n=24 Participants
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.
|
|---|---|---|
|
Smoking-Related Appraisals
Baseline
|
3.93 score on a scale
Standard Deviation .46
|
3.99 score on a scale
Standard Deviation .70
|
|
Smoking-Related Appraisals
End of Educational Sessions
|
3.80 score on a scale
Standard Deviation .60
|
3.86 score on a scale
Standard Deviation .69
|
|
Smoking-Related Appraisals
End of Smoking Cessation Sessions
|
2.73 score on a scale
Standard Deviation .86
|
2.57 score on a scale
Standard Deviation 1.03
|
PRIMARY outcome
Timeframe: Six weeks, which was the end of the Smoking Cessation Sessions.Population: Analysis based on the number of participants who completed 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.
Outcome measures
| Measure |
Genetic Education Session (GES)
n=28 Participants
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.
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.
|
Nutrition Education Session (NES)
n=25 Participants
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.
|
|---|---|---|
|
Smoking Abstinence at End of Smoking Cessation Sessions
Number of Participants Quit
|
11 Participants
|
10 Participants
|
|
Smoking Abstinence at End of Smoking Cessation Sessions
Number of Participants Not Quit
|
17 Participants
|
15 Participants
|
Adverse Events
Genetic Education Session (GES)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Nutrition Education Session (NES)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place