Behaviorally Enhanced Counseling on Nicotine Dependence (BEACON) Trial.

This study has been completed.
Sponsor:
Collaborators:
SRI International
Johns Hopkins University
University of Bristol
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT00991081
First received: October 6, 2009
Last updated: August 21, 2012
Last verified: August 2012
Results First Received: June 25, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Smoking
Interventions: Behavioral: Counseling
Behavioral: Self-help guide
Drug: Pharmacotherapy
Behavioral: Genetic feedback, verbal
Behavioral: Genetic feedback, printed

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Phase I and Phase II participants were recruited from members of Group Health Cooperative in Seattle, WA. Of the 36 Phase II participants enrolled, 32 had been previously genotyped for an earlier study and 4 were genotyped for this study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Formative Interviews

Phase 1 involved formative research to develop and refine a patient-centered, theoretically grounded behavioral intervention for delivering genetically-tailored smoking cessation treatment. We convened a panel of doctorate level experts (n = 10) in pharmacogenetics; smoking cessation treatment; ethical, legal and social implications of genetics research; genetic literacy; patient-clinician communications; and mixed-methods research to guide development of the pharmacogenetic treatment, GF and evaluation.

Next, smokers were asked about their familiarity with genetic concepts (e.g., DNA, genes), understanding of the roles genes play in smoking behavior and treatment response, reaction to the concept of genetically-tailoring pharmacotherapy, familiarity with the Genetic Information Nondiscrimination Act, concerns about privacy of genetic information, and interest in genetically-tailored treatment. Interviews were continued until response saturation was achieved (n = 10).

Standard Treatment Received behavioral counseling by telephone and either bupropion or nicotine replacement patch
Genetic Feedback Plus Standard Treatment Received genetic feedback regarding treatment selection in addition to behavioral counseling by telephone and either bupropion or nicotine replacement patch

Participant Flow for 2 periods

Period 1:   Phase I, Formative Research
    Formative Interviews     Standard Treatment     Genetic Feedback Plus Standard Treatment  
STARTED     20     0     0  
COMPLETED     20 [1]   0     0  
NOT COMPLETED     0     0     0  
[1] The 10 smokers interviewed were not enrolled in the Phase II RCT.

Period 2:   Phase II, Randomized Control Trial
    Formative Interviews     Standard Treatment     Genetic Feedback Plus Standard Treatment  
STARTED     0     17 [1]   19 [1]
Received First Clinical Call     0     16     17  
COMPLETED     0     15     15  
NOT COMPLETED     0     2     4  
[1] Phase I interview participants were not enrolled in the Phase II RCT.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Standard Treatment Received behavioral counseling by telephone and either bupropion or nicotine replacement patch
Genetic Feedback Plus Standard Treatment Received genetic feedback regarding treatment selection in addition to behavioral counseling by telephone and either bupropion or nicotine replacement patch
Total Total of all reporting groups

Baseline Measures
    Standard Treatment     Genetic Feedback Plus Standard Treatment     Total  
Number of Participants  
[units: participants]
  17     19     36  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     17     18     35  
>=65 years     0     1     1  
Age  
[units: years]
Mean ± Standard Deviation
  49.4  ± 10.6     52.7  ± 8.22     51.1  ± 9.42  
Gender  
[units: participants]
     
Female     11     12     23  
Male     6     7     13  
Region of Enrollment  
[units: participants]
     
United States     17     19     36  



  Outcome Measures
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1.  Primary:   Continuous Abstinence at 12 Weeks Post Target Quit Date   [ Time Frame: 12 weeks after Target Quit Date ]

2.  Secondary:   Morisky Adherence Scale   [ Time Frame: 12 weeks after Target Quit Date ]

3.  Secondary:   Trust Scale   [ Time Frame: Within 1 week of first clinical call ]

4.  Secondary:   Communication Scale   [ Time Frame: Within 1 week of first clinical call ]

5.  Secondary:   Satisfaction Scale   [ Time Frame: Within 1 week of first clinical call ]

6.  Secondary:   Treatment Interest Scale   [ Time Frame: Within 1 week of first clinical call ]

7.  Secondary:   Depression   [ Time Frame: Within 1 week of first clinical call ]

8.  Secondary:   Fatalism   [ Time Frame: 12 weeks after Target Quit Date ]

9.  Secondary:   Intention to Quit   [ Time Frame: Within 1 week of first clinical call ]

10.  Secondary:   Motivation   [ Time Frame: Within 1 week of first clinical call ]

11.  Secondary:   Perceived Control   [ Time Frame: Within 1 week of first clinical call ]

12.  Secondary:   Risk Perception   [ Time Frame: Within 1 week of first clinical call ]

13.  Secondary:   Self-Efficacy   [ Time Frame: Within 1 week of first clinical call ]

14.  Secondary:   Threat Minimization   [ Time Frame: Within 1 week of first clinical call ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Possible selection bias as 32 of 36 participants had taken part in previous research  


Results Point of Contact:  
Name/Title: Sean P. David, MD, SM, DPhil
Organization: Stanford University
phone: 650-498-4687
e-mail: spdavid@stanford.edu


Publications of Results:
McClure JB, Swan GE, St. John J, Fauver R, Javitz HS, Bergen AW, Nishita D, Niaura R, Munafò MR, David SP. Pharmacogenetic smoking cessation intervention in a health care setting: A Pilot Feasibility Study. Nicotine Tob Res. (2012, in press).


Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT00991081     History of Changes
Other Study ID Numbers: SU-09152009-3940, 5R21DA027331-03, Protocol # 16513
Study First Received: October 6, 2009
Results First Received: June 25, 2012
Last Updated: August 21, 2012
Health Authority: United States: Institutional Review Board