Behaviorally Enhanced Counseling on Nicotine Dependence (BEACON) Trial.

Study Overview
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Brief Summary
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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
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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.

Official Title
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Exploratory/Developmental Study of Pharmacogenetic Smoking Cessation Therapy.

Conditions
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Smoking

Intervention / Treatment
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* Behavioral: Counseling
* Behavioral: Self-help guide
* Drug: Pharmacotherapy
* Behavioral: Genetic feedback, verbal
* Behavioral: Genetic feedback, printed


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard treatment<br>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<br>* 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<br>* Other names: Motivational enhancement;Behavioral: Self-help guide<br>* A printed self-help guide for smoking cessation (Clearing the Air, NCI)sent by mail<br>* Other names: Clearing the Air;Drug: Pharmacotherapy<br>* 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<br>* Other names: Wellbutrin;|
| Experimental: Genetic feedback plus standard treatment<br>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<br>* 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<br>* Other names: Motivational enhancement;Behavioral: Self-help guide<br>* A printed self-help guide for smoking cessation (Clearing the Air, NCI)sent by mail<br>* Other names: Clearing the Air;Drug: Pharmacotherapy<br>* 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<br>* Other names: Wellbutrin;Behavioral: Genetic feedback, verbal<br>* During the first counseling call, GF participants were informed of their genotype and provided with the rationale for their pharmacotherapy assignment<br>* Other names: Pharmacogenetic counseling;Behavioral: Genetic feedback, printed<br>* 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.<br>* Other names: Pharmacogenetic Feedback;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pharmacogenetics, genetic counseling, genetic feedback, nicotine replacement, bupropion, smoking cessation, primary care, telehealth, motivational interviewing