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| Name | Class |
|---|---|
| Department of Health and Human Services | FED |
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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.
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:
The working hypotheses for the cessation-related cognitions are:
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Receipt of Genetic Results | Experimental | Receipt of Genetic Results indicates that participants have received the results of genotyping for RS1051730 |
|
| No results given | Active Comparator | Participants will not be offered to receive the results of genotyping for RS1051730 until all data collection has been completed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Receipt of Genetic Results | Behavioral | Participants will receive the results of genotyping for RS1051730 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Baseline Smoking Abstinence at 6 and 10 Weeks After Genotyping Results | Abstinence: Point-Prevalence & Continuous Self-Report; Exhaled Carbon Monoxide (CO): <= 6 ppm past 24 hrs.; Salivary Cotinine: <15 ng/ml past 7 days | Assessed at Weeks 6 and 10 after Genotyping Results, Week 10 reported |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Baseline Use of Pharmacotherapy at 6 and 10 Weeks After Genotyping Results | Use of Pharmacotherapy: Self-report of type and frequency of use of FDA-approved smoking cessation medications. | Assessed at Weeks 6 and 10 weeks after Genotyping Results, Week 10 reported. |
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Inclusion Criteria:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Julia F Houfek, PhD | University of Nebraska | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21678175 | Background | Smerecnik C, Quaak M, van Schayck CP, van Schooten FJ, de Vries H. Are smokers interested in genetic testing for smoking addiction? A socio-cognitive approach. Psychol Health. 2011 Aug;26(8):1099-112. doi: 10.1080/08870446.2010.541909. Epub 2011 Jun 28. | |
| 29793253 | Background | Brock AJ, Takeda A, Brennan C, Walton RT. Treatment for tobacco dependence: a potential application for stratified medicine? Per Med. 2011 Sep;8(5):571-579. doi: 10.2217/pme.11.60. |
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A total of 169 persons contacted the study coordinator (n = 169). Of these, 63 were lost to follow-up due to non-return of phone call when contacted. A total of 43 participants completed the assessment for eligibility. Of these 19 were excluded (7 did not meet the criteria and 12 declined to participate further). A total of 24 participants were randomized, 12 each to the experimental and control groups.
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| ID | Title | Description |
|---|---|---|
| FG000 | Receipt of Genetic Results | Receipt of Genetic Results indicates that participants have received the results of genotyping for RS1051730 Receipt of Genetic Results: Participants will receive the results of genotyping for RS1051730 |
| FG001 | No Results Given | Participants will not be offered to receive the results of genotyping for RS1051730 until all data collection has been completed. No results given: Participants will not be offered to receive the results of genotyping for RS1051730 until all data collection has been completed. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Receipt of Genetic Results | Receipt of Genetic Results indicates that participants have received the results of genotyping for RS1051730 Receipt of Genetic Results: Participants will receive the results of genotyping for RS1051730 |
| BG001 | No Results Given |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Baseline Smoking Abstinence at 6 and 10 Weeks After Genotyping Results | Abstinence: Point-Prevalence & Continuous Self-Report; Exhaled Carbon Monoxide (CO): <= 6 ppm past 24 hrs.; Salivary Cotinine: <15 ng/ml past 7 days | Posted | Count of Participants | Participants | Assessed at Weeks 6 and 10 after Genotyping Results, Week 10 reported |
|
Baseline through follow-up (10 weeks)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Receipt of Genetic Results | Receipt of Genetic Results indicates that participants have received the results of genotyping for RS1051730 Receipt of Genetic Results: Participants will receive the results of genotyping for RS1051730 |
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Recruitment goals were not met. Only 14% of those who inquired about the study enrolled. Most individuals who did not participate were interested in a smoking cessation study and/or a higher honorarium. Data collection times were streamlined to encourage continued study participation, which was successful. Recommendations include: (1) offering a smoking cessation component and (2) better explaining the practical benefit of knowing genetic risk for nicotine dependence during recruitment.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Julia F Houfek | University of Nebraska Medical Center | 402-660-4046 | jhoufek@unmc.edu |
Not provided
| ID | Term |
|---|---|
| D000073865 | Cigarette Smoking |
| D014029 | Tobacco Use Disorder |
| ID | Term |
|---|---|
| D000073869 | Tobacco Smoking |
| D012907 | Smoking |
| D001519 | Behavior |
| D064424 | Tobacco Use |
| D019966 |
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| No results given | Behavioral | Participants will not be offered to receive the results of genotyping for RS1051730 until all data collection has been completed. |
|
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Participants will not be offered to receive the results of genotyping for RS1051730 until all data collection has been completed. No results given: Participants will not be offered to receive the results of genotyping for RS1051730 until all data collection has been completed. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Participant Demographic Data | Count of Participants | Participants |
|
|
|
| Secondary | Change in Baseline Use of Pharmacotherapy at 6 and 10 Weeks After Genotyping Results | Use of Pharmacotherapy: Self-report of type and frequency of use of FDA-approved smoking cessation medications. | Posted | Count of Participants | Participants | Assessed at Weeks 6 and 10 weeks after Genotyping Results, Week 10 reported. |
|
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | No Results Given | Participants will not be offered to receive the results of genotyping for RS1051730 until all data collection has been completed. No results given: Participants will not be offered to receive the results of genotyping for RS1051730 until all data collection has been completed. | 0 | 12 | 0 | 12 | 0 | 12 |
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| Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |