Smokers' Response to Nicotine Dependence Genotyping

Nicotine Dependence Clinical Trial

Official title:

Smokers' Response to Nicotine Dependence Genotyping

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01780038
• Other study ID #: 069-12-FB
• Status: Completed
• Phase: N/A
• First received: January 25, 2013
• Last updated: January 30, 2018
• Start date: November 14, 2012
• Est. completion date: August 31, 2013

Study information

• Verified date: January 2018
• Source: University of Nebraska
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: August 31, 2013
• Est. primary completion date: August 31, 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cigarette Smoking
• Nicotine Dependence
• Tobacco Use Disorder

Intervention

Behavioral:
• Receipt of Genetic Results
Participants will receive the results of genotyping for RS1051730
• No results given
Participants will not be offered to receive the results of genotyping for RS1051730 until all data collection has been completed.

Locations

Country	Name	City	State
United States	University of Nebraska Medical Center	Omaha	Nebraska

Sponsors (2)

Lead Sponsor	Collaborator
University of Nebraska	Department of Health and Human Services

Country where clinical trial is conducted

United States, 

References & Publications (54)

Abrams, D.B., Niaura, R., Brown, R.A., Emmons, K.M., Goldstein, M.G., & Monti, P.M. (2003). The Tobacco Dependence Treatment Handbook: A Guide to Best Practices. New York: The Guilford Press.

Addicted to Nicotine: A National Research Forum. July 27-28, 1998. Bethesda, Maryland, USA. Proceedings. Nicotine Tob Res. 1999;1 Suppl 2:S1-215. — View Citation

Amos CI, Wu X, Broderick P, Gorlov IP, Gu J, Eisen T, Dong Q, Zhang Q, Gu X, Vijayakrishnan J, Sullivan K, Matakidou A, Wang Y, Mills G, Doheny K, Tsai YY, Chen WV, Shete S, Spitz MR, Houlston RS. Genome-wide association scan of tag SNPs identifies a susceptibility locus for lung cancer at 15q25.1. Nat Genet. 2008 May;40(5):616-22. doi: 10.1038/ng.109. Epub 2008 Apr 2. — View Citation

Audrain J, Boyd NR, Roth J, Main D, Caporaso NF, Lerman C. Genetic susceptibility testing in smoking-cessation treatment: one-year outcomes of a randomized trial. Addict Behav. 1997 Nov-Dec;22(6):741-51. — View Citation

Benowitz NL. Clinical pharmacology of nicotine: implications for understanding, preventing, and treating tobacco addiction. Clin Pharmacol Ther. 2008 Apr;83(4):531-41. doi: 10.1038/clpt.2008.3. Epub 2008 Feb 27. Review. — View Citation

Brock, A. J., Takeda, A., Brennan, C., & Walton, R. T. (2011). Treatment for tobacco dependence: A potential application for stratified medicine. Biomarkers Medicine, 8 (5), 571-579

Brownlee, S., Leventhal, H., & Leventhal, E. A. (2000). Regulation, self-regulation, and construction of the self in maintenance of physical health. In M. Boekaerts, P.R. Pintrich, & M. Zeidner, (Eds.). Handbook of Self-Regulation. San Diego, CA: Academic Press, pp. 369-416.

Cameron LD, Marteau TM, Brown PM, Klein WM, Sherman KA. Communication strategies for enhancing understanding of the behavioral implications of genetic and biomarker tests for disease risk: the role of coherence. J Behav Med. 2012 Jun;35(3):286-98. doi: 10.1007/s10865-011-9361-5. Epub 2011 Jun 23. — View Citation

Cappella, J.N., Lerman, C., Romantan, A., & Baruh, L. (2003). News about genetics and smoking. Communications Research, 32, 478-502.

CDC (2011a). Vital signs: Current cigarette smoking among adults aged > 18 years - United States, 2005-2010. MMWR, 60 (35), 1207-1211. 2. CDC (2011b). Quitting smoking among adults - United States, 2001-2010. MMWR, 60 (44), 1513-1519.

Cervone D. The architecture of personality. Psychol Rev. 2004 Jan;111(1):183-204. — View Citation

Cohen, J. (1988). Statistical Power Analysis for the Behavioral Sciences. Mahwah, NJ: Lawrence Erlbaum Associates, Inc.

Cokkinides VE, Ward E, Jemal A, Thun MJ. Under-use of smoking-cessation treatments: results from the National Health Interview Survey, 2000. Am J Prev Med. 2005 Jan;28(1):119-22. — View Citation

Condit CM. Public understandings of genetics and health. Clin Genet. 2010 Jan;77(1):1-9. doi: 10.1111/j.1399-0004.2009.01316.x. Review. — View Citation

Doak LG, Doak CC, Meade CD. Strategies to improve cancer education materials. Oncol Nurs Forum. 1996 Sep;23(8):1305-12. Review. — View Citation

Ducci F, Kaakinen M, Pouta A, Hartikainen AL, Veijola J, Isohanni M, Charoen P, Coin L, Hoggart C, Ekelund J, Peltonen L, Freimer N, Elliott P, Schumann G, Järvelin MR. TTC12-ANKK1-DRD2 and CHRNA5-CHRNA3-CHRNB4 influence different pathways leading to smoking behavior from adolescence to mid-adulthood. Biol Psychiatry. 2011 Apr 1;69(7):650-60. doi: 10.1016/j.biopsych.2010.09.055. Epub 2010 Dec 17. — View Citation

Etter JF, Bergman MM, Humair JP, Perneger TV. Development and validation of a scale measuring self-efficacy of current and former smokers. Addiction. 2000 Jun;95(6):901-13. — View Citation

Fiore, M. C., Jaen, C.R., Baker, T.B., et al. (2008). Treating Tobacco Use and Dependence. 2008 Update. Clinical Practice Guideline. Rockville, MD: U.S. Department of Health and Human Services. Public Health Service.

Henderson BJ, Maguire BT. Three lay mental models of disease inheritance. Soc Sci Med. 2000 Jan;50(2):293-301. — View Citation

Hendricks PS, Delucchi KL, Hall SM. Mechanisms of change in extended cognitive behavioral treatment for tobacco dependence. Drug Alcohol Depend. 2010 Jun 1;109(1-3):114-9. doi: 10.1016/j.drugalcdep.2009.12.021. Epub 2010 Jan 21. — View Citation

Hughes JR, Keely JP, Niaura RS, Ossip-Klein DJ, Richmond RL, Swan GE. Measures of abstinence in clinical trials: issues and recommendations. Nicotine Tob Res. 2003 Feb;5(1):13-25. Erratum in: Nicotine Tob Res. 2003 Aug;5(4):603. — View Citation

Hung RJ, McKay JD, Gaborieau V, Boffetta P, Hashibe M, Zaridze D, Mukeria A, Szeszenia-Dabrowska N, Lissowska J, Rudnai P, Fabianova E, Mates D, Bencko V, Foretova L, Janout V, Chen C, Goodman G, Field JK, Liloglou T, Xinarianos G, Cassidy A, McLaughlin J, Liu G, Narod S, Krokan HE, Skorpen F, Elvestad MB, Hveem K, Vatten L, Linseisen J, Clavel-Chapelon F, Vineis P, Bueno-de-Mesquita HB, Lund E, Martinez C, Bingham S, Rasmuson T, Hainaut P, Riboli E, Ahrens W, Benhamou S, Lagiou P, Trichopoulos D, Holcátová I, Merletti F, Kjaerheim K, Agudo A, Macfarlane G, Talamini R, Simonato L, Lowry R, Conway DI, Znaor A, Healy C, Zelenika D, Boland A, Delepine M, Foglio M, Lechner D, Matsuda F, Blanche H, Gut I, Heath S, Lathrop M, Brennan P. A susceptibility locus for lung cancer maps to nicotinic acetylcholine receptor subunit genes on 15q25. Nature. 2008 Apr 3;452(7187):633-7. doi: 10.1038/nature06885. — View Citation

Hung WT, Dunlop SM, Perez D, Cotter T. Use and perceived helpfulness of smoking cessation methods: results from a population survey of recent quitters. BMC Public Health. 2011 Jul 27;11:592. doi: 10.1186/1471-2458-11-592. — View Citation

Lerman C, Gold K, Audrain J, Lin TH, Boyd NR, Orleans CT, Wilfond B, Louben G, Caporaso N. Incorporating biomarkers of exposure and genetic susceptibility into smoking cessation treatment: effects on smoking-related cognitions, emotions, and behavior change. Health Psychol. 1997 Jan;16(1):87-99. — View Citation

Lerman CE, Schnoll RA, Munafò MR. Genetics and smoking cessation improving outcomes in smokers at risk. Am J Prev Med. 2007 Dec;33(6 Suppl):S398-405. Review. — View Citation

Liang, K.Y, & Zeger, S.L. (1986). Longitudinal data analysis using generalized linear models. Biometrika, 73, 13-22

Malaiyandi V, Sellers EM, Tyndale RF. Implications of CYP2A6 genetic variation for smoking behaviors and nicotine dependence. Clin Pharmacol Ther. 2005 Mar;77(3):145-58. Review. — View Citation

McBride CM, Bepler G, Lipkus IM, Lyna P, Samsa G, Albright J, Datta S, Rimer BK. Incorporating genetic susceptibility feedback into a smoking cessation program for African-American smokers with low income. Cancer Epidemiol Biomarkers Prev. 2002 Jun;11(6):521-8. — View Citation

Moss-Morris, R., Weinman, J., Petrie, K.J., Horne, R., Cameron, L.D., & Buick, D. (2002). The revised illness perception questionnaire (IPQ-R). Psychology & Health, 17, 1-16.

Munafò M, Clark T, Johnstone E, Murphy M, Walton R. The genetic basis for smoking behavior: a systematic review and meta-analysis. Nicotine Tob Res. 2004 Aug;6(4):583-97. Review. — View Citation

Munafò MR, Johnstone EC, Walther D, Uhl GR, Murphy MF, Aveyard P. CHRNA3 rs1051730 genotype and short-term smoking cessation. Nicotine Tob Res. 2011 Oct;13(10):982-8. doi: 10.1093/ntr/ntr106. Epub 2011 Jun 20. — View Citation

Park ER, Kleimann S, Youatt EJ, Lockhart A, Campbell EG, Levy DE, Halbert CH, Schmieder E, Krishna R, Shields AE. Black and White adults' perspectives on the genetics of nicotine addiction susceptibility. Addict Behav. 2011 Jul;36(7):769-72. doi: 10.1016/j.addbeh.2011.02.007. Epub 2011 Feb 25. — View Citation

Perkins, K.A., Conklin, C.A., & Levine, M.D. (2008). Cognitive-Behavioral Therapy for Smoking Cessation. New York: Routledge.

Pleasant A, McKinney J. Coming to consensus on health literacy measurement: an online discussion and consensus-gauging process. Nurs Outlook. 2011 Mar-Apr;59(2):95-106.e1. doi: 10.1016/j.outlook.2010.12.006. — View Citation

Quaak M, Smerecnik C, van Schooten FJ, de Vries H, van Schayck CP. Knowledge, attitudes and preferences regarding genetic testing for smoking cessation. A cross-sectional survey among Dutch smokers. BMJ Open. 2012 Jan 5;2:e000321. doi: 10.1136/bmjopen-2011-000321. Print 2012. — View Citation

Quaak M, van Schayck CP, Knaapen AM, van Schooten FJ. Genetic variation as a predictor of smoking cessation success. A promising preventive and intervention tool for chronic respiratory diseases? Eur Respir J. 2009 Mar;33(3):468-80. doi: 10.1183/09031936.00056908. Review. — View Citation

Read CY, Perry DJ, Duffy ME. Design and psychometric evaluation of the Psychological Adaptation to Genetic Information Scale. J Nurs Scholarsh. 2005;37(3):203-8. — View Citation

Sanderson SC, Michie S. Genetic testing for heart disease susceptibility: potential impact on motivation to quit smoking. Clin Genet. 2007 Jun;71(6):501-10. — View Citation

Sanderson SC, Waller J, Humphries SE, Wardle J. Public awareness of genetic influence on chronic disease risk: are genetic and lifestyle causal beliefs compatible? Public Health Genomics. 2011;14(4-5):290-7. doi: 10.1159/000294280. Epub 2010 Apr 29. — View Citation

Shadel WG, Mermelstein R, Borrelli B. Self-concept changes over time in cognitive-behavioral treatment for smoking cessation. Addict Behav. 1996 Sep-Oct;21(5):659-63. — View Citation

Smerecnik C, Grispen JE, Quaak M. Effectiveness of testing for genetic susceptibility to smoking-related diseases on smoking cessation outcomes: a systematic review and meta-analysis. Tob Control. 2012 May;21(3):347-54. doi: 10.1136/tc.2011.042739. Epub 2011 Sep 26. Review. — View Citation

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. — View Citation

Smerecnik CM, Mesters I, de Vries NK, de Vries H. Applying a theory-based framework to understand public knowledge of genetic risk factors: a case for the distinction between how-to knowledge and principles knowledge. Public Health Genomics. 2011;14(4-5):259-70. doi: 10.1159/000294149. Epub 2010 Mar 12. — View Citation

Smerecnik CM, Mesters I, de Vries NK, de Vries H. Educating the general public about multifactorial genetic disease: applying a theory-based framework to understand current public knowledge. Genet Med. 2008 Apr;10(4):251-8. doi: 10.1097/GIM.0b013e31816b4ffd. Review. — View Citation

Spielberger, C.D. (1995a). Scoring information for the revised STPI. Tampa: Center for Research in Behavioral Medicine and Health Psychology, University of South Florida.

Spielberger, C.D. (1995b). Preliminary Manual for the State-Trait Personality Inventory (STPI). Unpublished manual.

SRNT Subcommittee on Biochemical Verification. Biochemical verification of tobacco use and cessation. Nicotine Tob Res. 2002 May;4(2):149-59. — View Citation

Thorgeirsson TE, Geller F, Sulem P, Rafnar T, Wiste A, Magnusson KP, Manolescu A, Thorleifsson G, Stefansson H, Ingason A, Stacey SN, Bergthorsson JT, Thorlacius S, Gudmundsson J, Jonsson T, Jakobsdottir M, Saemundsdottir J, Olafsdottir O, Gudmundsson LJ, Bjornsdottir G, Kristjansson K, Skuladottir H, Isaksson HJ, Gudbjartsson T, Jones GT, Mueller T, Gottsäter A, Flex A, Aben KKH, de Vegt F, Mulders PFA, Isla D, Vidal MJ, Asin L, Saez B, Murillo L, Blondal T, Kolbeinsson H, Stefansson JG, Hansdottir I, Runarsdottir V, Pola R, Lindblad B, van Rij AM, Dieplinger B, Haltmayer M, Mayordomo JI, Kiemeney LA, Matthiasson SE, Oskarsson H, Tyrfingsson T, Gudbjartsson DF, Gulcher JR, Jonsson S, Thorsteinsdottir U, Kong A, Stefansson K. A variant associated with nicotine dependence, lung cancer and peripheral arterial disease. Nature. 2008 Apr 3;452(7187):638-642. doi: 10.1038/nature06846. — View Citation

United States Department of Health and Human Services, Healthy People 2020. (2012, January 9). Tobacco Use: Objectives. Retrieved from http://healthypeople.gov/2020/topicsobjectives2020/objectiveslist.aspx?topicId=41

Velicer WF, Diclemente CC, Rossi JS, Prochaska JO. Relapse situations and self-efficacy: an integrative model. Addict Behav. 1990;15(3):271-83. — View Citation

Weinman J, Petrie KJ. Illness perceptions: a new paradigm for psychosomatics? J Psychosom Res. 1997 Feb;42(2):113-6. — View Citation

Weinman, J., Petrie, K.J., Moss-Morris, R., & Horne, R. (1996). The illness perception questionnaire: A new method for assessing cognitive representations of illness. Psychology & Health, 11, 431-445.

Wright AJ, French DP, Weinman J, Marteau TM. Can genetic risk information enhance motivation for smoking cessation? An analogue study. Health Psychol. 2006 Nov;25(6):740-52. — View Citation

Wright AJ, Weinman J, Marteau TM. The impact of learning of a genetic predisposition to nicotine dependence: an analogue study. Tob Control. 2003 Jun;12(2):227-30. — View Citation

* Note: There are 54 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Baseline Knowledge of Genetic Contributions to Smoking at 2, 6, and 10 Weeks after Genotyping Results	Knowledge Test of Genetics & Smoking Investigator Developed. 20 items; correct items are summed. Scores 0-20. Higher scores indicate more knowledge.	2, 6, and 10 weeks after genotyping results
Primary	Change in Baseline Smoking Abstinence at 2, 6, and 10 Weeks after Genotyping Results	Abstinence: Point-Prevalence & Continuous Self-Report; Exhaled CO: <= 6 ppm past 24 hrs.; Salivary Cotinine: <15 ng/ml past 7 days	Weeks 2, 6, and 10 after genotyping results
Secondary	Change in Baseline Use of Pharmacotherapy at 2, 6, and 10 Weeks after Genotyping Results	Use of Pharmacotherapy: Self-report of type and frequency of use of FDA-approved smoking cessation medications. Verification of product at data collection.	2, 6, and 10 weeks after genotyping results