Behaviorally Enhanced Counseling on Nicotine Dependence (BEACON) Trial.

Exploratory/Developmental Study of Pharmacogenetic Smoking Cessation Therapy.

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.

Study Overview

• Status: Completed
• Conditions: Smoking
• Intervention / Treatment: Behavioral: Counseling; Behavioral: Self-help guide; Drug: Pharmacotherapy; Behavioral: Genetic feedback, verbal; Behavioral: Genetic feedback, printed

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 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.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • Menlo Park, California, United States, 94025
      • SRI International
    • Stanford, California, United States, 94305
      • Stanford University School of Medicine
  • Washington
    • Seattle, Washington, United States, 98101
      • Group Health Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard treatment; 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 pharmacotherapyParticipants 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; 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; Other Names: Motivational interviewing; Motivational enhancement; Behavioral: Self-help guide; A printed self-help guide for smoking cessation (Clearing the Air, NCI)sent by mail; Other Names: Support Materials; Clearing the Air; 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; Other Names: Wellbutrin; Zyban; Bupropion; Aplenzin; Nicotine Replacement Therapy; NRT; The Patch
Experimental: Genetic feedback plus standard treatment; 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; 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; Other Names: Motivational interviewing; Motivational enhancement; Behavioral: Self-help guide; A printed self-help guide for smoking cessation (Clearing the Air, NCI)sent by mail; Other Names: Support Materials; Clearing the Air; 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; Other Names: Wellbutrin; Zyban; Bupropion; Aplenzin; Nicotine Replacement Therapy; NRT; The Patch; 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; Other Names: Pharmacogenetics; Pharmacogenetic counseling; 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.; Other Names: Pharmacogenetics; Pharmacogenetic Feedback

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Morisky Adherence Scale	Category: Treatment Acceptability Measures: Treatment Compliance Range: 0-8 Direction: Higher values represent higher compliance	12 weeks after Target Quit Date
Trust Scale	Category: Treatment Acceptability Measures: Trust in the clinician Range: 5-30 Direction: Higher values represent higher trust	Within 1 week of first clinical call
Communication Scale	Category: Treatment Acceptability Measures: Quality of verbal interaction and responsiveness during counseling sessions Range: 4-20 Direction: Higher values represent greater interaction and responsiveness	Within 1 week of first clinical call
Satisfaction Scale	Category: Treatment Acceptability Measures: Overall satisfaction with the clinician Range: 4-20 Direction: Higher values represent higher satisfaction	Within 1 week of first clinical call
Treatment Interest Scale	Category: Treatment Acceptability Measures: Interest in participating in recommended treatment plan Range: 1-10 Direction: Higher values represent higher treatment interest	Within 1 week of first clinical call
Depression	Category: Psychological Outcome Instrument: Center for Epidemiologic Studies Depression Scale (CES-D) Measures: Interest in participating in recommended treatment plan Range: 0-60 Direction: Higher values represent increased symptoms of depression	Within 1 week of first clinical call
Fatalism	Category: Psychological Outcome Instrument: Powe Fatalism Inventory, 10-item, revised Measures: belief in inevitability of smoking status Range: 0-10 Direction: Higher values represent increased fatalism beliefs	12 weeks after Target Quit Date
Intention to Quit	Category: Psychological Outcome Instrument: 3-item inventory, Likert scale from 1 to 7 Measures: Intention, confidence, and expectation of quitting smoking Range: 3-21 Direction: Higher values represent increased intention to quit	Within 1 week of first clinical call
Motivation	Category: Psychological Outcome Instrument: Single item, Likert scale from 1 to 7 Measures: Desire to quit smoking Range: 1-7 Direction: Higher values represent increased motivation to quit	Within 1 week of first clinical call
Perceived Control	Category: Psychological Outcome Instrument: 3-item inventory, Likert scale from 1 to 7 Measures: Control over ability to quit smoking in the next month Range: 3-21 Direction: Higher values represent increased sense of control	Within 1 week of first clinical call
Risk Perception	Category: Psychological Outcome Instrument: 4-item inventory, Likert scale from 1 to 5 Measures: Perceived personal health risks from smoking Range: 4-20 Direction: Higher values represent increased perception of risk	Within 1 week of first clinical call
Self-Efficacy	Category: Psychological Outcome Instrument: 3-item inventory, Likert scale from 1 to 7 Measures: Perceived ability to quit smoking in the next month Range: 3-21 Direction: Higher values represent increased self-efficacy	Within 1 week of first clinical call
Threat Minimization	Category: Psychological Outcome Instrument: 2-item inventory, Likert scale from 1 to 7 Measures: Perceived presence of factors that would reduce personal smoking risks Range: 2-14 Direction: Higher values represent increased risk minimization	Within 1 week of first clinical call

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: National Institute on Drug Abuse (NIDA); Johns Hopkins University; University of Bristol; SRI International
• Investigators: Principal Investigator: Sean P David, MD SM DPhil, Stanford University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (Actual): March 1, 2011
• Study Completion (Actual): March 1, 2011

Study Registration Dates

• First Submitted: October 6, 2009
• First Submitted That Met QC Criteria: October 6, 2009
• First Posted (Estimate): October 7, 2009

Study Record Updates

• Last Update Posted (Estimate): September 19, 2012
• Last Update Submitted That Met QC Criteria: August 21, 2012
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Keywords: pharmacogenetics; primary care; smoking cessation; bupropion; motivational interviewing; telehealth; genetic counseling; nicotine replacement; genetic feedback
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Enzyme Inhibitors; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Antidepressive Agents; Dopamine Agents; Cytochrome P-450 Enzyme Inhibitors; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Antidepressive Agents, Second-Generation; Cytochrome P-450 CYP2D6 Inhibitors; Dopamine Uptake Inhibitors; Nicotine; Bupropion
• Other Study ID Numbers: SU-09152009-3940; 5R21DA027331-03 (U.S. NIH Grant/Contract); Protocol # 16513 (Other Identifier: Stanford IRB)