Behaviorally Enhanced Counseling on Nicotine Dependence (BEACON) Trial.
NCT ID: NCT00991081
Last Updated: 2012-09-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
36 participants
INTERVENTIONAL
2009-07-31
2011-03-31
Brief Summary
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Detailed Description
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Aim 1: Conduct formative research to develop and refine a clinical protocol for a multi-component smoking cessation intervention, grounded in the extended parallel process model, consisting of pharmacogenetic treatment (smoking cessation drug matched to each individual smoker's genotype) and genetic feedback (delivery of patient-centered, personalized genotype information and its predictive value for smoking cessation treatment efficacy): We will adapt, pilot-test, and refine a theoretically-grounded PGx smoking cessation intervention using formative interviews of 20 African-American and European-ancestry smokers.
Aim 2: Conduct a mixed-methods feasibility trial randomizing treatment-seeking smokers to pharmacogenetic (PGx) treatment combined with genetic feedback (GF) vs. PGx treatment without GF for smoking cessation to examine the feasibility of the newly developed protocol in a primary care setting and characterize its psychological and behavioral impact: Smokers (N = 100) will be randomized to GF vs. no GF and all will receive motivational interviewing (standard care/SC) and PGx treatment. We will assess the impact of GF on time to relapse, medication adherence, and a comprehensive assessment battery of process and cognitive, psychological, and behavioral outcomes. Finally, we will synthesize quantitative and qualitative data to revise protocols, generate hypothesizes, and estimate effect sizes for a follow-up R01 submission.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Standard treatment
* Three 20-minute telephone calls during which a certified tobacco treatment specialist delivered motivationally-enhanced cognitive behavioral counseling.
* A self-help guide for smoking cessation (Clearing the Air, NCI)sent by mail
* A standard 8-week course of genetically-tailored pharmacotherapy
* Participants with the A1 allele (TT/CT) were assigned to receive NRT (the Patch)
* Participants with the A2 allele (CC) were assigned to receive bupropion
Counseling
Three 20-minute telephone calls during which a certified tobacco treatment specialist delivered motivationally-enhanced cognitive behavioral counseling
1. One week prior to the target quit date (TQD)
2. Two weeks post-TQD
3. Four weeks post-TQD
Self-help guide
A printed self-help guide for smoking cessation (Clearing the Air, NCI)sent by mail
Pharmacotherapy
8-week course of genetically-tailored pharmacotherapy
* Participants with the A1 allele (TT/CT) were assigned to receive NRT (the Patch)
* Participants with the A2 allele (CC) were assigned to receive bupropion
Genetic feedback plus standard treatment
In addition to the standard treatment, participants in this arm received the following interventions:
* Genetic feedback, verbal - During the first counseling call, GF participants were informed of their genotype and provided with the rationale for their pharmacotherapy assignment
* Genetic feedback, printed - After the first counseling call, GF participants were mailed a Personal Treatment Profile, which echoed each participant's ANNK1 genotype, the implications of this for smoking cessation treatment outcome, and which medication was chosen for them based on their genotype
Counseling
Three 20-minute telephone calls during which a certified tobacco treatment specialist delivered motivationally-enhanced cognitive behavioral counseling
1. One week prior to the target quit date (TQD)
2. Two weeks post-TQD
3. Four weeks post-TQD
Self-help guide
A printed self-help guide for smoking cessation (Clearing the Air, NCI)sent by mail
Pharmacotherapy
8-week course of genetically-tailored pharmacotherapy
* Participants with the A1 allele (TT/CT) were assigned to receive NRT (the Patch)
* Participants with the A2 allele (CC) were assigned to receive bupropion
Genetic feedback, verbal
During the first counseling call, GF participants were informed of their genotype and provided with the rationale for their pharmacotherapy assignment
Genetic feedback, printed
After the first counseling call, GF participants were mailed a Personal Treatment Profile, which echoed each participant's ANNK1 genotype, the implications of this for smoking cessation treatment outcome, and which medication was chosen for them based on their genotype.
Interventions
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Counseling
Three 20-minute telephone calls during which a certified tobacco treatment specialist delivered motivationally-enhanced cognitive behavioral counseling
1. One week prior to the target quit date (TQD)
2. Two weeks post-TQD
3. Four weeks post-TQD
Self-help guide
A printed self-help guide for smoking cessation (Clearing the Air, NCI)sent by mail
Pharmacotherapy
8-week course of genetically-tailored pharmacotherapy
* Participants with the A1 allele (TT/CT) were assigned to receive NRT (the Patch)
* Participants with the A2 allele (CC) were assigned to receive bupropion
Genetic feedback, verbal
During the first counseling call, GF participants were informed of their genotype and provided with the rationale for their pharmacotherapy assignment
Genetic feedback, printed
After the first counseling call, GF participants were mailed a Personal Treatment Profile, which echoed each participant's ANNK1 genotype, the implications of this for smoking cessation treatment outcome, and which medication was chosen for them based on their genotype.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Currently smoke at least 10 cigarettes per day
* Motivated to quit smoking (\>=5 on a 10-point Likert scale)
* Have a telephone
* Read and speak English.
Exclusion Criteria
* DSM-IV Axis I diagnosis (other than nicotine dependence)
* Subjects who meet criteria for current major depression, or who demonstrate evidence of suicidal ideation at screening will be referred to treatment for depression and will be excluded from the study
* Must agree not to seek other treatment for smoking cessation during the study.
18 Years
ALL
No
Sponsors
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SRI International
INDUSTRY
Johns Hopkins University
OTHER
University of Bristol
OTHER
National Institute on Drug Abuse (NIDA)
NIH
Stanford University
OTHER
Responsible Party
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Principal Investigators
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Sean P David, MD SM DPhil
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Locations
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SRI International
Menlo Park, California, United States
Stanford University School of Medicine
Stanford, California, United States
Group Health Research Institute
Seattle, Washington, United States
Countries
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References
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McClure JB, Swan GE, St John J, Fauver R, Javitz HS, Bergen AW, Nishita D, Niaura R, Munafo MR, David SP. Pharmacogenetic smoking cessation intervention in a health care setting: a pilot feasibility study. Nicotine Tob Res. 2013 Feb;15(2):518-26. doi: 10.1093/ntr/nts173. Epub 2012 Sep 4.
Other Identifiers
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Protocol # 16513
Identifier Type: OTHER
Identifier Source: secondary_id
SU-09152009-3940
Identifier Type: -
Identifier Source: org_study_id