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Cigarette SmokingNCT01780038

Smokers' Response to Nicotine Dependence Genotyping

A study testing Receipt of Genetic Results and No results given in people with Cigarette Smoking and Nicotine Dependence, run by University of Nebraska at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 19 years and olderHealthy volunteers can take part
Conditions the study is for
Cigarette Smoking, Nicotine Dependence
What is being tested?
Receipt of Genetic Results and No results given
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteUnited States
Study dates
14 Nov 2012to 31 Aug 2013
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • >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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198

Other trials in United States

About this study

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.

Read the 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.

Being tested
Receipt of Genetic Results, No results given
Keywords
Cigarette Smoking, Nicotine Dependence, Smoking Abstinence, Health Literacy, Genetic Predisposition Testing, Heredity
Medical subject headings
Cigarette Smoking, Tobacco Use Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Receipt of Genetic ResultsBehavioural

    Participants will receive the results of genotyping for RS1051730

  • No results givenBehavioural

    Participants will not be offered to receive the results of genotyping for RS1051730 until all data collection has been completed.

Study groups in NCT01780038
Study groupRoleWhat they receive
Receipt of Genetic ResultsExperimentalReceipt of Genetic Results indicates that participants have received the results of genotyping for RS1051730
Receives: Behavioral: Receipt of Genetic Results
No results givenActive comparatorParticipants will not be offered to receive the results of genotyping for RS1051730 until all data collection has been completed.
Receives: Behavioral: No results given

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Assessed at Weeks 6 and 10 after Genotyping Results, Week 10 reported

Secondary outcomes (1)

  1. 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.

    Measured: Assessed at Weeks 6 and 10 weeks after Genotyping Results, Week 10 reported.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jan 2013 (estimated)
  2. Study start14 Nov 2012
  3. Primary completion31 Aug 2013
  4. Study completion31 Aug 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01780038
Sponsor's protocol ID
0069-12-FB
Status last verified
Aug 2024
First submitted
25 Jan 2013
Last updated
31 Oct 2024
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 21678175

  • 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.

    PubMed 29793253

  • Addicted to Nicotine: A National Research Forum. July 27-28, 1998. Bethesda, Maryland, USA. Proceedings. Nicotine Tob Res. 1999;1 Suppl 2:S1-215. No abstract available.

    PubMed 12022131

  • 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.

  • 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.

  • 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

  • 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(1):e000321. doi: 10.1136/bmjopen-2011-000321. Print 2012.

    PubMed 22223839

  • 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. doi: 10.1111/j.1547-5069.2005.00036.x.

    PubMed 16235859

  • 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.

    PubMed 18414207

  • 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.

    PubMed 21402205

  • Weinman J, Petrie KJ. Illness perceptions: a new paradigm for psychosomatics? J Psychosom Res. 1997 Feb;42(2):113-6. doi: 10.1016/s0022-3999(96)00294-2. No abstract available.

    PubMed 9076639

  • 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.

  • Munafo 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. doi: 10.1080/14622200410001734030.

    PubMed 15370155

  • Cervone D. The architecture of personality. Psychol Rev. 2004 Jan;111(1):183-204. doi: 10.1037/0033-295X.111.1.183.

    PubMed 14756593

  • 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.

    PubMed 18305452

Questions about this trial

What is this clinical trial studying?

A study testing Receipt of Genetic Results and No results given in people with Cigarette Smoking and Nicotine Dependence, run by University of Nebraska at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Baseline Smoking Abstinence at 6 and 10 Weeks After Genotyping Results (time frame: Assessed at Weeks 6 and 10 after Genotyping Results, Week 10 reported). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01780038, which also lists 54 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2024.

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