Behaviorally Enhanced Counseling on Nicotine Dependence (BEACON) Trial.

NCT00991081 | Completed Phase 4 Results DMC

• 3 other identifiers: SU-09152009-39405R21DA027331-03Protocol # 16513
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 3

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

Conditions

Smoking

Keywords

pharmacogenetics; genetic counseling; genetic feedback; nicotine replacement; bupropion; smoking cessation; primary care; telehealth; motivational interviewing

Outcome Measures

Primary Outcomes (1)

• Continuous Abstinence at 12 Weeks Post Target Quit Date

  Participants reporting continuous tobacco-use abstinence 12 weeks after their Target Quit Date, whose salivary cotinine levels confirmed their abstinence, were counted as "abstinent." All others were recorded as not abstinent.

  12 weeks after Target Quit Date

Secondary Outcomes (13)

• Morisky Adherence Scale

  12 weeks after Target Quit Date

• Trust Scale

  Within 1 week of first clinical call

• Communication Scale

  Within 1 week of first clinical call

• Satisfaction Scale

  Within 1 week of first clinical call

• Treatment Interest Scale

  Within 1 week of first clinical call

Study Arms (2)

Standard treatment

ACTIVE COMPARATOR

* 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

Behavioral: Counseling; Behavioral: Self-help guide; Drug: Pharmacotherapy

Genetic feedback plus standard treatment

EXPERIMENTAL

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

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

Interventions

Counseling BEHAVIORAL

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

Also known as: Motivational interviewing, Motivational enhancement

Genetic feedback plus standard treatment; Standard treatment

Self-help guide BEHAVIORAL

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

Also known as: Support Materials, Clearing the Air

Genetic feedback plus standard treatment; Standard treatment

Pharmacotherapy DRUG

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

Also known as: NRT, Nicotine Replacement Therapy, The Patch, Bupropion, Zyban, Aplenzin, Wellbutrin

Genetic feedback plus standard treatment; Standard treatment

Genetic feedback, verbal BEHAVIORAL

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

Also known as: Pharmacogenetics, Pharmacogenetic counseling

Genetic feedback plus standard treatment

Genetic feedback, printed BEHAVIORAL

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.

Also known as: Pharmacogenetics, Pharmacogenetic Feedback

Genetic feedback plus standard treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Stanford University: lead
• SRI International: collaborator
• Johns Hopkins University: collaborator
• University of Bristol: collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (3)

SRI International

Menlo Park, California, 94025, United States

Location

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Group Health Research Institute

Seattle, Washington, 98101, United States

Location

Related Publications (1)

• McClure JB, Swan GE, St John J, Fauver R, Javitz HS, Bergen AW, Nishita D, Niaura R, Munafo MR, David SP. Pharmacogenetic smoking cessation intervention in a health care setting: a pilot feasibility study. Nicotine Tob Res. 2013 Feb;15(2):518-26. doi: 10.1093/ntr/nts173. Epub 2012 Sep 4.

  PMID: 22949583 RESULT

MeSH Terms

Conditions

Smoking; Smoking Cessation

Interventions

Counseling; Motivational Interviewing; Drug Therapy; Nicotine Replacement Therapy; Bupropion; Pharmacogenomic Testing

Condition Hierarchy (Ancestors)

Behavior; Health Behavior

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Directive Counseling; Therapeutics; Propiophenones; Ketones; Organic Chemicals; Genetic Testing; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Genetic Techniques; Genetic Services; Diagnostic Services; Preventive Health Services

Limitations and Caveats

Possible selection bias as 32 of 36 participants had taken part in previous research

Results Point of Contact

• Title: Sean P. David, MD, SM, DPhil
• Organization: Stanford University

spdavid@stanford.edu

650-498-4687

Study Officials

• Sean P David, MD SM DPhil

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2009
• First Posted: October 7, 2009
• Study Start: July 1, 2009
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: September 19, 2012
• Results First Posted: September 19, 2012

Record last verified: 2012-08

Locations

US (3)