Behaviorally Enhanced Counseling on Nicotine Dependence (BEACON) Trial.

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.

Conditions

• Smoking

Interventions

BEHAVIORAL

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

BEHAVIORAL

Self-help guide

A printed self-help guide for smoking cessation (Clearing the Air, NCI)sent by mail

DRUG

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

BEHAVIORAL

Genetic feedback, verbal

During the first counseling call, GF participants were informed of their genotype and provided with the rationale for their pharmacotherapy assignment

BEHAVIORAL

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.

Sponsors & Collaborators

• SRI International

  collaborator INDUSTRY

• Johns Hopkins University

  collaborator OTHER

• University of Bristol

  collaborator OTHER

• National Institute on Drug Abuse (NIDA)

  collaborator NIH

• Stanford University

  lead OTHER

Principal Investigators

• Sean P David, MD SM DPhil · Stanford University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-07-31

Primary Completion

2011-03-31

Completion

2011-03-31

Countries

• United States

Study Locations