Trial Outcomes & Findings for Behaviorally Enhanced Counseling on Nicotine Dependence (BEACON) Trial. (NCT NCT00991081)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

36 participants

Primary outcome timeframe

12 weeks after Target Quit Date

Results posted on

2012-09-19

Participant Flow

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.

Participant milestones

Participant milestones
Measure	Formative Interviews 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).	Standard Treatment Received behavioral counseling by telephone and either bupropion or nicotine replacement patch	Genetic Feedback Plus Standard Treatment Received genetic feedback regarding treatment selection in addition to behavioral counseling by telephone and either bupropion or nicotine replacement patch
Phase I, Formative Research STARTED	20	0	0
Phase I, Formative Research COMPLETED	20	0	0
Phase I, Formative Research NOT COMPLETED	0	0	0
Phase II, Randomized Control Trial STARTED	0	17	19
Phase II, Randomized Control Trial Received First Clinical Call	0	16	17
Phase II, Randomized Control Trial COMPLETED	0	15	15
Phase II, Randomized Control Trial NOT COMPLETED	0	2	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Behaviorally Enhanced Counseling on Nicotine Dependence (BEACON) Trial.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Standard Treatment n=17 Participants Received behavioral counseling by telephone and either bupropion or nicotine replacement patch	Genetic Feedback Plus Standard Treatment n=19 Participants Received genetic feedback regarding treatment selection in addition to behavioral counseling by telephone and either bupropion or nicotine replacement patch	Total n=36 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	17 Participants n=5 Participants	18 Participants n=7 Participants	35 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Age Continuous	49.4 years STANDARD_DEVIATION 10.6 • n=5 Participants	52.7 years STANDARD_DEVIATION 8.22 • n=7 Participants	51.1 years STANDARD_DEVIATION 9.42 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	12 Participants n=7 Participants	23 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants
Region of Enrollment United States	17 participants n=5 Participants	19 participants n=7 Participants	36 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks after Target Quit Date

Population: All randomized participants were included in the data analysis.

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.

Outcome measures

Outcome measures
Measure	Standard Treatment n=17 Participants Received behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch	Genetic Feedback Plus Standard Treatment n=19 Participants Received genetic feedback regarding treatment selection in addition to behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
Continuous Abstinence at 12 Weeks Post Target Quit Date	3 participants	2 participants

SECONDARY outcome

Timeframe: 12 weeks after Target Quit Date

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

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

Outcome measures

Outcome measures
Measure	Standard Treatment n=15 Participants Received behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch	Genetic Feedback Plus Standard Treatment n=15 Participants Received genetic feedback regarding treatment selection in addition to behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
Morisky Adherence Scale	2.7 units on a scale Standard Deviation 1.9	1.8 units on a scale Standard Deviation 1.6

SECONDARY outcome

Timeframe: Within 1 week of first clinical call

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

Category: Treatment Acceptability Measures: Trust in the clinician Range: 5-30 Direction: Higher values represent higher trust

Outcome measures

Outcome measures
Measure	Standard Treatment n=16 Participants Received behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch	Genetic Feedback Plus Standard Treatment n=17 Participants Received genetic feedback regarding treatment selection in addition to behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
Trust Scale	19.3 units on a scale Standard Deviation 2.5	18.8 units on a scale Standard Deviation 2.3

SECONDARY outcome

Timeframe: Within 1 week of first clinical call

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

Category: Treatment Acceptability Measures: Quality of verbal interaction and responsiveness during counseling sessions Range: 4-20 Direction: Higher values represent greater interaction and responsiveness

Outcome measures

Outcome measures
Measure	Standard Treatment n=16 Participants Received behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch	Genetic Feedback Plus Standard Treatment n=17 Participants Received genetic feedback regarding treatment selection in addition to behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
Communication Scale	19.4 units on a scale Standard Deviation 1.4	19.4 units on a scale Standard Deviation 1.5

SECONDARY outcome

Timeframe: Within 1 week of first clinical call

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

Category: Treatment Acceptability Measures: Overall satisfaction with the clinician Range: 4-20 Direction: Higher values represent higher satisfaction

Outcome measures

Outcome measures
Measure	Standard Treatment n=16 Participants Received behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch	Genetic Feedback Plus Standard Treatment n=17 Participants Received genetic feedback regarding treatment selection in addition to behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
Satisfaction Scale	19.4 units on a scale Standard Deviation 1.8	19.5 units on a scale Standard Deviation 0.8

SECONDARY outcome

Timeframe: Within 1 week of first clinical call

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

Category: Treatment Acceptability Measures: Interest in participating in recommended treatment plan Range: 1-10 Direction: Higher values represent higher treatment interest

Outcome measures

Outcome measures
Measure	Standard Treatment n=16 Participants Received behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch	Genetic Feedback Plus Standard Treatment n=17 Participants Received genetic feedback regarding treatment selection in addition to behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
Treatment Interest Scale	9.0 units on a scale Standard Deviation 1.6	9.6 units on a scale Standard Deviation 0.74

SECONDARY outcome

Timeframe: Within 1 week of first clinical call

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

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

Outcome measures

Outcome measures
Measure	Standard Treatment n=16 Participants Received behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch	Genetic Feedback Plus Standard Treatment n=17 Participants Received genetic feedback regarding treatment selection in addition to behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
Depression	6.1 units on a scale Standard Deviation 7.8	4.1 units on a scale Standard Deviation 8.2

SECONDARY outcome

Timeframe: 12 weeks after Target Quit Date

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

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

Outcome measures

Outcome measures
Measure	Standard Treatment n=15 Participants Received behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch	Genetic Feedback Plus Standard Treatment n=15 Participants Received genetic feedback regarding treatment selection in addition to behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
Fatalism	1.1 units on a scale Standard Deviation 1.8	0.4 units on a scale Standard Deviation 1.0

SECONDARY outcome

Timeframe: Within 1 week of first clinical call

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

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

Outcome measures

Outcome measures
Measure	Standard Treatment n=16 Participants Received behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch	Genetic Feedback Plus Standard Treatment n=17 Participants Received genetic feedback regarding treatment selection in addition to behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
Intention to Quit	18.3 units on a scale Standard Deviation 2.9	19.5 units on a scale Standard Deviation 1.9

SECONDARY outcome

Timeframe: Within 1 week of first clinical call

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

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

Outcome measures

Outcome measures
Measure	Standard Treatment n=16 Participants Received behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch	Genetic Feedback Plus Standard Treatment n=17 Participants Received genetic feedback regarding treatment selection in addition to behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
Motivation	6.2 units on a scale Standard Deviation 1.0	6.4 units on a scale Standard Deviation 0.73

SECONDARY outcome

Timeframe: Within 1 week of first clinical call

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

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

Outcome measures

Outcome measures
Measure	Standard Treatment n=16 Participants Received behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch	Genetic Feedback Plus Standard Treatment n=17 Participants Received genetic feedback regarding treatment selection in addition to behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
Perceived Control	14.0 units on a scale Standard Deviation 2.5	13.4 units on a scale Standard Deviation 3.4

SECONDARY outcome

Timeframe: Within 1 week of first clinical call

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

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

Outcome measures

Outcome measures
Measure	Standard Treatment n=16 Participants Received behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch	Genetic Feedback Plus Standard Treatment n=17 Participants Received genetic feedback regarding treatment selection in addition to behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
Risk Perception	15.3 units on a scale Standard Deviation 2.8	16.1 units on a scale Standard Deviation 2.5

SECONDARY outcome

Timeframe: Within 1 week of first clinical call

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

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

Outcome measures

Outcome measures
Measure	Standard Treatment n=16 Participants Received behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch	Genetic Feedback Plus Standard Treatment n=17 Participants Received genetic feedback regarding treatment selection in addition to behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
Self-Efficacy	16.2 units on a scale Standard Deviation 2.5	15.6 units on a scale Standard Deviation 2.6

SECONDARY outcome

Timeframe: Within 1 week of first clinical call

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

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

Outcome measures

Outcome measures
Measure	Standard Treatment n=16 Participants Received behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch	Genetic Feedback Plus Standard Treatment n=17 Participants Received genetic feedback regarding treatment selection in addition to behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
Threat Minimization	8.9 units on a scale Standard Deviation 2.9	7.3 units on a scale Standard Deviation 3.6

Adverse Events

Standard Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Genetic Feedback Plus Standard Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Sean P. David, MD, SM, DPhil

Stanford University

Phone: 650-498-4687

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place