Behaviorally Enhanced Counseling on Nicotine Dependence (BEACON) Trial.

Stanford University

Status and phase: Completed; Phase 4

Conditions: Smoking

Treatments: Behavioral: Counseling; Behavioral: Self-help guide; Behavioral: Genetic feedback, printed; Drug: Pharmacotherapy; Behavioral: Genetic feedback, verbal

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT00991081

Protocol # 16513 (Other Identifier)

SU-09152009-3940

5R21DA027331-03 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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 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.

Enrollment: 36 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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36 participants in 2 patient groups

Standard treatment

Active Comparator group

Description:

* 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

Treatment:

Behavioral: Counseling

Drug: Pharmacotherapy

Behavioral: Self-help guide

Genetic feedback plus standard treatment

Experimental group

Description:

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

Treatment:

Behavioral: Genetic feedback, verbal

Behavioral: Counseling

Behavioral: Genetic feedback, printed

Drug: Pharmacotherapy

Behavioral: Self-help guide