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Smokers' Response to Nicotine Dependence Genotyping
NA trial testing Receipt of Genetic Results in Cigarette Smoking in 24 participants. Completed in 31 August 2013.
| Lead sponsor | University of Nebraska |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 24 |
| Start date | 14 November 2012 |
| Primary completion | 31 August 2013 |
| Estimated completion | 31 August 2013 |
| Sites | 1 location across United States |
University of Nebraska
19 and older, any sex, with Cigarette Smoking or Nicotine Dependence. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Abstinence: Point-Prevalence \& Continuous Self-Report; Exhaled Carbon Monoxide (CO): \<= 6 ppm past 24 hrs.; Salivary Cotinine: \<15 ng/ml past 7 days
| Group | Value | 95% CI |
|---|---|---|
| Receipt of Genetic Results | 1 | |
| No Results Given | 0 | |
| Receipt of Genetic Results | 7 | |
| No Results Given | 11 |
Use of Pharmacotherapy: Self-report of type and frequency of use of FDA-approved smoking cessation medications.
| Group | Value | 95% CI |
|---|---|---|
| Receipt of Genetic Results | 2 | |
| No Results Given | 2 | |
| Receipt of Genetic Results | 6 | |
| No Results Given | 9 |
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.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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