Smokers' Response to Nicotine Dependence Genotyping
| Status: | Completed |
|---|---|
| Conditions: | Smoking Cessation, Tobacco Consumers |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 19 - Any |
| Updated: | 2/3/2018 |
| Start Date: | November 14, 2012 |
| End Date: | August 31, 2013 |
Innovative strategies to reduce adult smoking prevalence include using genetic information to
motivate cessation and, ultimately, to tailor cessation pharmacotherapy. Success of these
interventions depends, in part, on smokers' interest and participation in genetic testing
related to cessation and their understanding and use of the results (i.e., their genetic
literacy). The recent availability of genetic risk testing for a nicotinic acetylcholine
receptor gene (CHRNA3) variant (rs105173) associated with nicotine dependence makes it highly
feasible to investigate smokers' interest in and use of genetic information about nicotine
dependence. Therefore, the primary purpose of this study is to determine the impact of an
intervention that provides smokers with an educational session about genetic contributions to
smoking and nicotine dependence plus their genotype results for rs1051730 on smoking
cessation outcomes compared to those who receive only the educational session. Secondary
purposes are to determine: (a) the impact of genetic education and knowing personal genotype
results on genetic literacy outcomes and (b) the feasibility of recruitment and retention
methods in a study addressing genotyping for nicotine dependence. Primary outcomes are
cessation-related behaviors and cognitions indicating abstinence. Secondary outcomes are
cognitions and emotions indicating genetic literacy. Knowledge gained from this study has the
potential for clinical translation so that as genotyping becomes part of smoking cessation,
health-care providers can understand and address factors influencing smokers' adaptation to
genetically-informed cessation treatment. The study will use a longitudinal, repeated
measures design (experimental, control; N=90; 45/group). All participants will receive a
90-minute educational session about genetic contributions for smoking and nicotine dependence
and will donate a buccal swab sample for genotyping. The investigators will then randomize
participants to two groups: those who receive genotyping results in a genetic counseling
session (experimental) and those who do not (control). Follow-up data will be collected from
both groups at baseline and weeks 2, 6, 10 after the experimental group receives genotyping
results, with a brief follow-up and study termination occurring at week 12. Control group
participants will be offered their genotyping results at the end of the study.
motivate cessation and, ultimately, to tailor cessation pharmacotherapy. Success of these
interventions depends, in part, on smokers' interest and participation in genetic testing
related to cessation and their understanding and use of the results (i.e., their genetic
literacy). The recent availability of genetic risk testing for a nicotinic acetylcholine
receptor gene (CHRNA3) variant (rs105173) associated with nicotine dependence makes it highly
feasible to investigate smokers' interest in and use of genetic information about nicotine
dependence. Therefore, the primary purpose of this study is to determine the impact of an
intervention that provides smokers with an educational session about genetic contributions to
smoking and nicotine dependence plus their genotype results for rs1051730 on smoking
cessation outcomes compared to those who receive only the educational session. Secondary
purposes are to determine: (a) the impact of genetic education and knowing personal genotype
results on genetic literacy outcomes and (b) the feasibility of recruitment and retention
methods in a study addressing genotyping for nicotine dependence. Primary outcomes are
cessation-related behaviors and cognitions indicating abstinence. Secondary outcomes are
cognitions and emotions indicating genetic literacy. Knowledge gained from this study has the
potential for clinical translation so that as genotyping becomes part of smoking cessation,
health-care providers can understand and address factors influencing smokers' adaptation to
genetically-informed cessation treatment. The study will use a longitudinal, repeated
measures design (experimental, control; N=90; 45/group). All participants will receive a
90-minute educational session about genetic contributions for smoking and nicotine dependence
and will donate a buccal swab sample for genotyping. The investigators will then randomize
participants to two groups: those who receive genotyping results in a genetic counseling
session (experimental) and those who do not (control). Follow-up data will be collected from
both groups at baseline and weeks 2, 6, 10 after the experimental group receives genotyping
results, with a brief follow-up and study termination occurring at week 12. Control group
participants will be offered their genotyping results at the end of the study.
The primary aim of this study is:
Aim 1. Determine the impact of knowing personal genotyping results for nicotine dependence
risk on the smoking cessation (primary) outcomes at weeks 2, 6, and 10.
The working hypotheses for the cessation-related behaviors are:
1. When compared to the control group, the experimental group will have greater: (1)
smoking abstinence; (2) use of formal smoking cessation programs; (3) contact with
health-care provider for cessation; (4) use of pharmacotherapy, and (5) use of
self-management strategies for cessation.
2. There will be no difference in the number of quit attempts between the experimental and
control groups.
The working hypotheses for the cessation-related cognitions are:
1. When compared to the control group, the experimental group will have higher
self-efficacy for smoking cessation.
2. When compared to the control group, the experimental group will have higher abstainer
and lower smoker self-schemas.
The secondary aims are:
Aim 2. Determine the impact of knowing personal genotyping results for nicotine dependence
risk on the secondary genetic literacy (secondary) outcomes at weeks 2, 6, and 10.
The working hypotheses for the genetic literacy-related cognitions and emotions are:
1. When compared to the control group, the experimental group will have greater: (1)
knowledge of genetic contributions to smoking, (2) mental representations indicating
endorsement of genetic risk for nicotine dependence, (3) accurate perceptions of genetic
risk for nicotine dependence, and (4) self-efficacy for use of genotyping results.
2. There will be no difference in psychological distress between the experimental and
control groups.
Aim 3. Explore smokers' perceptions and experiences that contextualize participation in
genetic education and genotyping for nicotine dependence risk. We will conduct focus groups
with both the intervention and control group participants at weeks 2 and 6 after intervention
group participants receive their genotyping results.
Aim 4. Determine the feasibility of an intervention that informs people of their personal
genotype results for nicotine dependence risk for a larger clinical trial, including
evaluation of enrollment (recruitment efficiency, attrition, problems and solutions),
intervention fidelity (delivery, receipt, enactment), data collection, subject acceptability
of the intervention, and estimation of effect sizes for sample size determination in future,
larger clinical trials.
Aim 1. Determine the impact of knowing personal genotyping results for nicotine dependence
risk on the smoking cessation (primary) outcomes at weeks 2, 6, and 10.
The working hypotheses for the cessation-related behaviors are:
1. When compared to the control group, the experimental group will have greater: (1)
smoking abstinence; (2) use of formal smoking cessation programs; (3) contact with
health-care provider for cessation; (4) use of pharmacotherapy, and (5) use of
self-management strategies for cessation.
2. There will be no difference in the number of quit attempts between the experimental and
control groups.
The working hypotheses for the cessation-related cognitions are:
1. When compared to the control group, the experimental group will have higher
self-efficacy for smoking cessation.
2. When compared to the control group, the experimental group will have higher abstainer
and lower smoker self-schemas.
The secondary aims are:
Aim 2. Determine the impact of knowing personal genotyping results for nicotine dependence
risk on the secondary genetic literacy (secondary) outcomes at weeks 2, 6, and 10.
The working hypotheses for the genetic literacy-related cognitions and emotions are:
1. When compared to the control group, the experimental group will have greater: (1)
knowledge of genetic contributions to smoking, (2) mental representations indicating
endorsement of genetic risk for nicotine dependence, (3) accurate perceptions of genetic
risk for nicotine dependence, and (4) self-efficacy for use of genotyping results.
2. There will be no difference in psychological distress between the experimental and
control groups.
Aim 3. Explore smokers' perceptions and experiences that contextualize participation in
genetic education and genotyping for nicotine dependence risk. We will conduct focus groups
with both the intervention and control group participants at weeks 2 and 6 after intervention
group participants receive their genotyping results.
Aim 4. Determine the feasibility of an intervention that informs people of their personal
genotype results for nicotine dependence risk for a larger clinical trial, including
evaluation of enrollment (recruitment efficiency, attrition, problems and solutions),
intervention fidelity (delivery, receipt, enactment), data collection, subject acceptability
of the intervention, and estimation of effect sizes for sample size determination in future,
larger clinical trials.
Inclusion Criteria:
- >19 years of age;
- smoking>= 10 cigarettes/day;
- intention to quit smoking at some time in the future;
- able to understand, speak, and write in English, and
- physically and mentally able to participate.
The investigators are excluding participants who do not understand, speak or write in
English at this time because: (1) the consent document, the educational genetics
presentation, and data collection forms are currently written in English only and (2)the
resources to make the educational presentation and data collection documents
culturally-specific for other cultures are not available. In making the study relevant for
non-English speaking participants, it is not only a literal translation the presentation
and documents into another language that is needed, but the ideas of health and heredity
from the culture related to the language also need to be taken into account when presenting
the study and the study materials in another language.
Exclusion Criteria:
- current treatment for a mental disorder with psychotic symptoms;
- diagnosis of cancer (other than basal or squamous cell skin cancer) or other
life-threatening illness;
- pregnant, or
- currently enrolled in another smoking research study.
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