Status:
COMPLETED
Behaviorally Enhanced Counseling on Nicotine Dependence (BEACON) Trial.
Lead Sponsor:
Stanford University
Collaborating Sponsors:
SRI International
Johns Hopkins University
Conditions:
Smoking
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The major purpose of this exploratory developmental study will be to develop a patient-centered and feasible protocol for communicating genetic data as it relates to drug efficacy for smoking cessatio...
Detailed Description
Therefore, our specific aims are to: Aim 1: Conduct formative research to develop and refine a clinical protocol for a multi-component smoking cessation intervention, grounded in the extended paralle...
Eligibility Criteria
Inclusion
- Inclusion and exclusion criteria are the same for participants in the formative interviews (Study A) and the feasibility RCT (Study B) except that Study A will include African American and European American smokers and Study B will include European American smokers.
- Inclusion criteria:
- Adults (aged 18 or older)
- 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:
- Any medical contraindications for transdermal nicotine replacement therapy (NRT) or sustained-release bupropion hydrochloride (bupropion) use based on the package labels (e.g., for bupropion, risk of seizure)
- 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.
Exclusion
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00991081
Start Date
July 1 2009
End Date
March 1 2011
Last Update
September 19 2012
Active Locations (3)
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1
SRI International
Menlo Park, California, United States, 94025
2
Stanford University School of Medicine
Stanford, California, United States, 94305
3
Group Health Research Institute
Seattle, Washington, United States, 98101