Behaviorally Enhanced Counseling on Nicotine Dependence (BEACON) Trial.
Condition: Smoking
Intervention: Counseling; Self-help guide; Pharmacotherapy; Genetic feedback, verbal; Genetic feedback, printed
Intervention description: Three 20-minute telephone calls during which a certified tobacco treatment specialist delivered motivationally-enhanced cognitive behavioral counseling
One week prior to the target quit date (TQD)
Two weeks post-TQD
Four weeks post-TQD; A printed self-help guide for smoking cessation (Clearing the Air, NCI)sent by mail; 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; During the first counseling call, GF participants were informed of their genotype and provided with the rationale for their pharmacotherapy assignment; 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.
Intervention MeSH terms: Bupropion; Nicotine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 36.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: pharmacogenetics; genetic counseling; genetic feedback; nicotine replacement; bupropion; smoking cessation; primary care; telehealth; motivational interviewing

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 cessation inpatients receiving medication that is matched to individual
      genotypes associated with increased efficacy for bupropion or nicotine replacement therapy.
    

Eligibility criteria:

        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.