Smokers' Response to Nicotine Dependence Genotyping

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by University of Nebraska
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Julia Houfek, PhD, University of Nebraska
ClinicalTrials.gov Identifier:
NCT01780038
First received: January 25, 2013
Last updated: January 28, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention
Cigarette Smoking
Nicotine Dependence
Behavioral: Receipt of Genetic Results
Behavioral: No results given

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Smokers' Response to Nicotine Dependence Genotyping

Resource links provided by NLM:


Further study details as provided by University of Nebraska:

Primary Outcome Measures:
  • Change in Baseline Smoking Abstinence at 2, 6, and 10 Weeks after Genotyping Results [ Time Frame: Weeks 2, 6, and 10 after genotyping results ] [ Designated as safety issue: No ]
    Abstinence: Point-Prevalence & Continuous Self-Report; Exhaled CO: <= 6 ppm past 24 hrs.; Salivary Cotinine: <15 ng/ml past 7 days


Secondary Outcome Measures:
  • Change in Baseline Use of Pharmacotherapy at 2, 6, and 10 Weeks after Genotyping Results [ Time Frame: 2, 6, and 10 weeks after genotyping results ] [ Designated as safety issue: No ]
    Use of Pharmacotherapy: Self-report of type and frequency of use of FDA-approved smoking cessation medications. Verification of product at data collection.


Other Outcome Measures:
  • Change in Baseline Knowledge of Genetic Contributions to Smoking at 2, 6, and 10 Weeks after Genotyping Results [ Time Frame: 2, 6, and 10 weeks after genotyping results ] [ Designated as safety issue: No ]
    Knowledge Test of Genetics & Smoking Investigator Developed. 20 items; correct items are summed. Scores 0-20. Higher scores indicate more knowledge.


Estimated Enrollment: 150
Study Start Date: October 2012
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Receipt of Genetic Results
Receipt of Genetic Results indicates that participants have received the results of genotyping for RS1051730
Behavioral: Receipt of Genetic Results
Participants will receive the results of genotyping for RS1051730
Active Comparator: No results given
Participants will not be offered to receive the results of genotyping for RS1051730 until all data collection has been completed.
Behavioral: No results given
Participants will not be offered to receive the results of genotyping for RS1051730 until all data collection has been completed.

Detailed 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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01780038

Contacts
Contact: Victoria M Graeve-Cunningham, MBA, MS 402-559-6549 v.graevecunningham@unmc.edu
Contact: Julia F Houfek, PhD 402-559-6542 jhoufek@unmc.edu

Locations
United States, Nebraska
University of Nebraska Medical Center Recruiting
Omaha, Nebraska, United States, 68198
Contact: Victoria M Graeve-Cunningham, MBA, MS    402-559-6549    v.graevecunningham@unmc.edu   
Contact: Julia F Houfek, PhD    402-559-6542    jhoufek@unmc.edu   
Principal Investigator: Julia F Houfek, PhD         
Sub-Investigator: Gwendoyln M Reiser, MS, CGC         
Sub-Investigator: Tricia LeVan, PhD         
Sub-Investigator: Stephen I Rennard, MD         
Sponsors and Collaborators
University of Nebraska
Investigators
Principal Investigator: Julia F Houfek, PhD University of Nebraska
  More Information

Publications:
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.
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 KK, de Vegt F, Mulders PF, 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):638-42. doi: 10.1038/nature06846.
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.
Lerman, C.E., Schnoll, R.A., & Munafo, M.R. (2007). Genetics and smoking cessation. American Journal of Preventive Medicine, 33 (6S), S398-S405.
Liang, K.Y, & Zeger, S.L. (1986). Longitudinal data analysis using generalized linear models. Biometrika, 73, 13-22

Responsible Party: Julia Houfek, PhD, Professor, PhD, APRN-CNS, University of Nebraska
ClinicalTrials.gov Identifier: NCT01780038     History of Changes
Other Study ID Numbers: 069-12-FB
Study First Received: January 25, 2013
Last Updated: January 28, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Nebraska:
Cigarette Smoking
Nicotine Dependence
Smoking Abstinence
Health Literacy
Genetic Predisposition Testing
Heredity

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 19, 2014