Behaviorally Enhanced Counseling on Nicotine Dependence (BEACON) Trial.
- Conditions
- Smoking
- Interventions
- Behavioral: CounselingBehavioral: Self-help guideDrug: PharmacotherapyBehavioral: Genetic feedback, verbalBehavioral: Genetic feedback, printed
- Registration Number
- NCT00991081
- Lead Sponsor
- Stanford University
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard treatment Pharmacotherapy * 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 Genetic feedback plus standard treatment Counseling 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 Genetic feedback plus standard treatment Self-help guide 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 Standard treatment Counseling * 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 Standard treatment Self-help guide * 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 Genetic feedback plus standard treatment Pharmacotherapy 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 Genetic feedback plus standard treatment Genetic feedback, verbal 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 Genetic feedback plus standard treatment Genetic feedback, printed 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
- Primary Outcome Measures
Name Time Method Continuous Abstinence at 12 Weeks Post Target Quit Date 12 weeks after 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.
- Secondary Outcome Measures
Name Time Method Morisky Adherence Scale 12 weeks after Target Quit Date Category: Treatment Acceptability Measures: Treatment Compliance Range: 0-8 Direction: Higher values represent higher compliance
Trust Scale Within 1 week of first clinical call Category: Treatment Acceptability Measures: Trust in the clinician Range: 5-30 Direction: Higher values represent higher trust
Communication Scale Within 1 week of first clinical call Category: Treatment Acceptability Measures: Quality of verbal interaction and responsiveness during counseling sessions Range: 4-20 Direction: Higher values represent greater interaction and responsiveness
Satisfaction Scale Within 1 week of first clinical call Category: Treatment Acceptability Measures: Overall satisfaction with the clinician Range: 4-20 Direction: Higher values represent higher satisfaction
Treatment Interest Scale Within 1 week of first clinical call Category: Treatment Acceptability Measures: Interest in participating in recommended treatment plan Range: 1-10 Direction: Higher values represent higher treatment interest
Depression Within 1 week of first clinical call 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
Fatalism 12 weeks after Target Quit Date 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
Intention to Quit Within 1 week of first clinical call 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
Motivation Within 1 week of first clinical call 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
Perceived Control Within 1 week of first clinical call 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
Risk Perception Within 1 week of first clinical call 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
Self-Efficacy Within 1 week of first clinical call 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
Threat Minimization Within 1 week of first clinical call 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
Trial Locations
- Locations (3)
Group Health Research Institute
🇺🇸Seattle, Washington, United States
Stanford University School of Medicine
🇺🇸Stanford, California, United States
SRI International
🇺🇸Menlo Park, California, United States