Smokers' Response to Nicotine Dependence Genotyping

NCT01780038 | Completed Results

• 1 other identifier: 0069-12-FB
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cigarette Smoking; Nicotine Dependence

Keywords

Cigarette Smoking; Nicotine Dependence; Smoking Abstinence; Health Literacy; Genetic Predisposition Testing; Heredity

Outcome Measures

Primary Outcomes (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

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

Secondary Outcomes (1)

• Change in Baseline Use of Pharmacotherapy at 6 and 10 Weeks After Genotyping Results

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

Study Arms (2)

Receipt of Genetic Results

EXPERIMENTAL

Receipt of Genetic Results indicates that participants have received the results of genotyping for RS1051730

Behavioral: Receipt of Genetic Results

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.

Behavioral: No results given

Interventions

Receipt of Genetic Results BEHAVIORAL

Participants will receive the results of genotyping for RS1051730

Receipt of Genetic Results

No results given BEHAVIORAL

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

No results given

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Nebraska: lead
• Department of Health and Human Services: collaborator

Study Sites (1)

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

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MeSH Terms

Conditions

Cigarette Smoking; Tobacco Use Disorder

Condition Hierarchy (Ancestors)

Tobacco Smoking; Smoking; Behavior; Tobacco Use; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Limitations and Caveats

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.

Results Point of Contact

• Title: Julia F Houfek
• Organization: University of Nebraska Medical Center

jhoufek@unmc.edu

402-660-4046

Study Officials

• Julia F Houfek, PhD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2013
• First Posted: January 30, 2013
• Study Start: November 14, 2012
• Primary Completion: August 31, 2013
• Study Completion: August 31, 2013
• Last Updated: October 31, 2024
• Results First Posted: October 31, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)