Behaviorally Enhanced Counseling on Nicotine Dependence (BEACON) Trial.

• Sponsor: Stanford University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00991081
• Collaborator: SRI International (Industry), Johns Hopkins University (Other), University of Bristol (Other), National Institute on Drug Abuse (NIDA) (NIH)
• Enrollment: 36
• Locations: 3
• Arms: 2
• Duration (Months): 20
• Patients Per Site: 12
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Smoking	Behavioral: Counseling; Behavioral: Self-help guide; Drug: Pharmacotherapy; Behavioral: Genetic feedback, verbal; Behavioral: Genetic feedback, printed	Phase 4

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 Design

• Study Type: Interventional
• Actual Enrollment: 36 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Exploratory/Developmental Study of Pharmacogenetic Smoking Cessation Therapy.
• Study Start Date: Jul 1, 2009
• Actual Primary Completion Date: Mar 1, 2011
• Actual Study Completion Date: Mar 1, 2011

Arms and Interventions

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 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; 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: NRT Nicotine Replacement Therapy The Patch Bupropion Zyban Aplenzin Wellbutrin
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: NRT Nicotine Replacement Therapy The Patch Bupropion Zyban Aplenzin Wellbutrin ; 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

Outcome Measures

Primary Outcome Measures

1. 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

1. Morisky Adherence Scale [12 weeks after Target Quit Date]

   Category: Treatment Acceptability Measures: Treatment Compliance Range: 0-8 Direction: Higher values represent higher compliance

2. 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

3. 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

4. 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

5. 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

6. 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

7. 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

8. 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

9. 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

10. 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

11. 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

12. 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

13. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	SRI International	Menlo Park	California	United States	94025
2	Stanford University School of Medicine	Stanford	California	United States	94305
3	Group Health Research Institute	Seattle	Washington	United States	98101

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Sean P David, MD SM DPhil, Stanford University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Stanford University
• ClinicalTrials.gov Identifier: NCT00991081
• Other Study ID Numbers: SU-09152009-3940; 5R21DA027331-03; Protocol # 16513
• First Posted: Oct 7, 2009
• Last Update Posted: Sep 19, 2012
• Last Verified: Aug 1, 2012

• Keywords provided by Stanford University: pharmacogenetics; genetic counseling; genetic feedback; nicotine replacement; bupropion; smoking cessation; primary care; telehealth; motivational interviewing
• Additional relevant MeSH terms: Bupropion; Nicotine

Study Results

Participant Flow

Recruitment Details	Phase I and Phase II participants were recruited from members of Group Health Cooperative in Seattle, WA. Of the 36 Phase II participants enrolled, 32 had been previously genotyped for an earlier study and 4 were genotyped for this study.

Arm/Group Title	Formative Interviews	Standard Treatment	Genetic Feedback Plus Standard Treatment
Arm/Group Description	Phase 1 involved formative research to develop and refine a patient-centered, theoretically grounded behavioral intervention for delivering genetically-tailored smoking cessation treatment. We convened a panel of doctorate level experts (n = 10) in pharmacogenetics; smoking cessation treatment; ethical, legal and social implications of genetics research; genetic literacy; patient-clinician communications; and mixed-methods research to guide development of the pharmacogenetic treatment, GF and evaluation. Next, smokers were asked about their familiarity with genetic concepts (e.g., DNA, genes), understanding of the roles genes play in smoking behavior and treatment response, reaction to the concept of genetically-tailoring pharmacotherapy, familiarity with the Genetic Information Nondiscrimination Act, concerns about privacy of genetic information, and interest in genetically-tailored treatment. Interviews were continued until response saturation was achieved (n = 10).	Received behavioral counseling by telephone and either bupropion or nicotine replacement patch	Received genetic feedback regarding treatment selection in addition to behavioral counseling by telephone and either bupropion or nicotine replacement patch
Period Title: Phase I, Formative Research
STARTED	20	0	0
COMPLETED	20	0	0
NOT COMPLETED	0	0	0
Period Title: Phase I, Formative Research
STARTED	0	17	19
Received First Clinical Call	0	16	17
COMPLETED	0	15	15
NOT COMPLETED	0	2	4

Baseline Characteristics

Arm/Group Title	Standard Treatment	Genetic Feedback Plus Standard Treatment	Total
Arm/Group Description	Received behavioral counseling by telephone and either bupropion or nicotine replacement patch	Received genetic feedback regarding treatment selection in addition to behavioral counseling by telephone and either bupropion or nicotine replacement patch	Total of all reporting groups
Overall Participants	17	19	36
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	17 100%	18 94.7%	35 97.2%
>=65 years	0 0%	1 5.3%	1 2.8%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	49.4 (10.6)	52.7 (8.22)	51.1 (9.42)
Sex: Female, Male (Count of Participants)
Female	11 64.7%	12 63.2%	23 63.9%
Male	6 35.3%	7 36.8%	13 36.1%
Region of Enrollment (participants) [Number]
United States	17 100%	19 100%	36 100%

Outcome Measures

1. Primary Outcome

Title	Continuous Abstinence at 12 Weeks Post Target Quit Date
Description	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.
Time Frame	12 weeks after Target Quit Date

Outcome Measure Data

Analysis Population Description

All randomized participants were included in the data analysis.

Arm/Group Title	Standard Treatment	Genetic Feedback Plus Standard Treatment
Arm/Group Description	Received behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch	Received genetic feedback regarding treatment selection in addition to behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
Measure Participants	17	19
Number [participants]	3 17.6%	2 10.5%

2. Secondary Outcome

Title	Morisky Adherence Scale
Description	Category: Treatment Acceptability Measures: Treatment Compliance Range: 0-8 Direction: Higher values represent higher compliance
Time Frame	12 weeks after Target Quit Date

Outcome Measure Data

Analysis Population Description

Follow-up treatment satisfaction analyses includes only those participants not lost to follow-up (n = 30)

Arm/Group Title	Standard Treatment	Genetic Feedback Plus Standard Treatment
Arm/Group Description	Received behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch	Received genetic feedback regarding treatment selection in addition to behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
Measure Participants	15	15
Mean (Standard Deviation) [units on a scale]	2.7 (1.9)	1.8 (1.6)

3. Secondary Outcome

Title	Trust Scale
Description	Category: Treatment Acceptability Measures: Trust in the clinician Range: 5-30 Direction: Higher values represent higher trust
Time Frame	Within 1 week of first clinical call

Outcome Measure Data

Analysis Population Description

First treatment satisfaction analyses include participants who received the first clinical call (n = 33)

Arm/Group Title	Standard Treatment	Genetic Feedback Plus Standard Treatment
Arm/Group Description	Received behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch	Received genetic feedback regarding treatment selection in addition to behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
Measure Participants	16	17
Mean (Standard Deviation) [units on a scale]	19.3 (2.5)	18.8 (2.3)

4. Secondary Outcome

Title	Communication Scale
Description	Category: Treatment Acceptability Measures: Quality of verbal interaction and responsiveness during counseling sessions Range: 4-20 Direction: Higher values represent greater interaction and responsiveness
Time Frame	Within 1 week of first clinical call

Outcome Measure Data

Analysis Population Description

First treatment satisfaction analyses include participants who received the first clinical call (n = 33)

Arm/Group Title	Standard Treatment	Genetic Feedback Plus Standard Treatment
Arm/Group Description	Received behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch	Received genetic feedback regarding treatment selection in addition to behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
Measure Participants	16	17
Mean (Standard Deviation) [units on a scale]	19.4 (1.4)	19.4 (1.5)

5. Secondary Outcome

Title	Satisfaction Scale
Description	Category: Treatment Acceptability Measures: Overall satisfaction with the clinician Range: 4-20 Direction: Higher values represent higher satisfaction
Time Frame	Within 1 week of first clinical call

Outcome Measure Data

Analysis Population Description

First treatment satisfaction analyses include participants who received the first clinical call (n = 33)

Arm/Group Title	Standard Treatment	Genetic Feedback Plus Standard Treatment
Arm/Group Description	Received behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch	Received genetic feedback regarding treatment selection in addition to behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
Measure Participants	16	17
Mean (Standard Deviation) [units on a scale]	19.4 (1.8)	19.5 (0.8)

6. Secondary Outcome

Title	Treatment Interest Scale
Description	Category: Treatment Acceptability Measures: Interest in participating in recommended treatment plan Range: 1-10 Direction: Higher values represent higher treatment interest
Time Frame	Within 1 week of first clinical call

Outcome Measure Data

Analysis Population Description

First treatment satisfaction analyses include participants who received the first clinical call (n = 33)

Arm/Group Title	Standard Treatment	Genetic Feedback Plus Standard Treatment
Arm/Group Description	Received behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch	Received genetic feedback regarding treatment selection in addition to behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
Measure Participants	16	17
Mean (Standard Deviation) [units on a scale]	9.0 (1.6)	9.6 (0.74)

7. Secondary Outcome

Title	Depression
Description	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
Time Frame	Within 1 week of first clinical call

Outcome Measure Data

Analysis Population Description

First psychological outcome analyses include participants who received the first clinical call (n = 30)

Arm/Group Title	Standard Treatment	Genetic Feedback Plus Standard Treatment
Arm/Group Description	Received behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch	Received genetic feedback regarding treatment selection in addition to behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
Measure Participants	16	17
Mean (Standard Deviation) [units on a scale]	6.1 (7.8)	4.1 (8.2)

8. Secondary Outcome

Title	Fatalism
Description	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
Time Frame	12 weeks after Target Quit Date

Outcome Measure Data

Analysis Population Description

Follow-up psychological outcome analyses include only those participants not lost to follow-up (n = 30)

Arm/Group Title	Standard Treatment	Genetic Feedback Plus Standard Treatment
Arm/Group Description	Received behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch	Received genetic feedback regarding treatment selection in addition to behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
Measure Participants	15	15
Mean (Standard Deviation) [units on a scale]	1.1 (1.8)	0.4 (1.0)

9. Secondary Outcome

Title	Intention to Quit
Description	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
Time Frame	Within 1 week of first clinical call

Outcome Measure Data

Analysis Population Description

First psychological outcome analyses include participants who received the first clinical call (n = 33)

Arm/Group Title	Standard Treatment	Genetic Feedback Plus Standard Treatment
Arm/Group Description	Received behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch	Received genetic feedback regarding treatment selection in addition to behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
Measure Participants	16	17
Mean (Standard Deviation) [units on a scale]	18.3 (2.9)	19.5 (1.9)

10. Secondary Outcome

Title	Motivation
Description	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
Time Frame	Within 1 week of first clinical call

Outcome Measure Data

Analysis Population Description

First psychological outcome analyses include participants who received the first clinical call (n = 33)

Arm/Group Title	Standard Treatment	Genetic Feedback Plus Standard Treatment
Arm/Group Description	Received behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch	Received genetic feedback regarding treatment selection in addition to behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
Measure Participants	16	17
Mean (Standard Deviation) [units on a scale]	6.2 (1.0)	6.4 (0.73)

11. Secondary Outcome

Title	Perceived Control
Description	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
Time Frame	Within 1 week of first clinical call

Outcome Measure Data

Analysis Population Description

First psychological outcome analyses include participants who received the first clinical call (n = 33)

Arm/Group Title	Standard Treatment	Genetic Feedback Plus Standard Treatment
Arm/Group Description	Received behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch	Received genetic feedback regarding treatment selection in addition to behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
Measure Participants	16	17
Mean (Standard Deviation) [units on a scale]	14.0 (2.5)	13.4 (3.4)

12. Secondary Outcome

Title	Risk Perception
Description	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
Time Frame	Within 1 week of first clinical call

Outcome Measure Data

Analysis Population Description

First psychological outcome analyses include participants who received the first clinical call (n = 33)

Arm/Group Title	Standard Treatment	Genetic Feedback Plus Standard Treatment
Arm/Group Description	Received behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch	Received genetic feedback regarding treatment selection in addition to behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
Measure Participants	16	17
Mean (Standard Deviation) [units on a scale]	15.3 (2.8)	16.1 (2.5)

13. Secondary Outcome

Title	Self-Efficacy
Description	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
Time Frame	Within 1 week of first clinical call

Outcome Measure Data

Analysis Population Description

First psychological outcome analyses include participants who received the first clinical call (n = 33)

Arm/Group Title	Standard Treatment	Genetic Feedback Plus Standard Treatment
Arm/Group Description	Received behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch	Received genetic feedback regarding treatment selection in addition to behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
Measure Participants	16	17
Mean (Standard Deviation) [units on a scale]	16.2 (2.5)	15.6 (2.6)

14. Secondary Outcome

Title	Threat Minimization
Description	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
Time Frame	Within 1 week of first clinical call

Outcome Measure Data

Analysis Population Description

First psychological outcome analyses include participants who received the first clinical call (n = 33)

Arm/Group Title	Standard Treatment	Genetic Feedback Plus Standard Treatment
Arm/Group Description	Received behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch	Received genetic feedback regarding treatment selection in addition to behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
Measure Participants	16	17
Mean (Standard Deviation) [units on a scale]	8.9 (2.9)	7.3 (3.6)

Adverse Events

Time Frame	2 years
Arm/Group Title	Standard Treatment		Genetic Feedback Plus Standard Treatment
Arm/Group Description	Received behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch		Received genetic feedback regarding treatment selection in addition to behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
All Cause Mortality
	Standard Treatment		Genetic Feedback Plus Standard Treatment
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Standard Treatment		Genetic Feedback Plus Standard Treatment
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/17 (0%)		0/19 (0%)
Other (Not Including Serious) Adverse Events
	Standard Treatment		Genetic Feedback Plus Standard Treatment
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/17 (0%)		0/19 (0%)

Limitations/Caveats

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

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.