Smoking
Conditions
Keywords
pharmacogenetics, genetic counseling, genetic feedback, nicotine replacement, bupropion, smoking cessation, primary care, telehealth, motivational interviewing
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.
Interventions
BEHAVIORALCounseling
Three 20-minute telephone calls during which a certified tobacco treatment specialist delivered motivationally-enhanced cognitive behavioral counseling 1. One week prior to the target quit date (TQD) 2. Two weeks post-TQD 3. Four weeks post-TQD
BEHAVIORALSelf-help guide
A printed self-help guide for smoking cessation (Clearing the Air, NCI)sent by mail
DRUGPharmacotherapy
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
BEHAVIORALGenetic feedback, verbal
During the first counseling call, GF participants were informed of their genotype and provided with the rationale for their pharmacotherapy assignment
BEHAVIORALGenetic 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.
Sponsors
SRI International
Johns Hopkins University
University of Bristol
National Institute on Drug Abuse (NIDA)
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Morisky Adherence Scale | 12 weeks after Target Quit Date | Category: Treatment Acceptability Measures: Treatment Compliance Range: 0-8 Direction: Higher values represent higher compliance |
| 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 |
| 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 |
Countries
United States
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.
Participants by arm
| Arm | Count |
|---|---|
| Standard Treatment Received behavioral counseling by telephone and either bupropion or nicotine replacement patch | 17 |
| 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 | 19 |
| Total | 36 |
Baseline characteristics
| Characteristic | Genetic Feedback Plus Standard Treatment | Standard Treatment | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 0 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 18 Participants | 17 Participants | 35 Participants |
| Age Continuous | 52.7 years STANDARD_DEVIATION 8.22 | 49.4 years STANDARD_DEVIATION 10.6 | 51.1 years STANDARD_DEVIATION 9.42 |
| Region of Enrollment United States | 19 participants | 17 participants | 36 participants |
| Sex: Female, Male Female | 12 Participants | 11 Participants | 23 Participants |
| Sex: Female, Male Male | 7 Participants | 6 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 17 | 0 / 19 |
| serious Total, serious adverse events | 0 / 17 | 0 / 19 |
Outcome results
Primary
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.
Time frame: 12 weeks after Target Quit Date
Population: All randomized participants were included in the data analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard Treatment | Continuous Abstinence at 12 Weeks Post Target Quit Date | 3 participants |
| Genetic Feedback Plus Standard Treatment | Continuous Abstinence at 12 Weeks Post Target Quit Date | 2 participants |
Secondary
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
Time frame: Within 1 week of first clinical call
Population: First treatment satisfaction analyses include participants who received the first clinical call (n = 33)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Treatment | Communication Scale | 19.4 units on a scale | Standard Deviation 1.4 |
| Genetic Feedback Plus Standard Treatment | Communication Scale | 19.4 units on a scale | Standard Deviation 1.5 |
Secondary
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
Time frame: Within 1 week of first clinical call
Population: First psychological outcome analyses include participants who received the first clinical call (n = 30)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Treatment | Depression | 6.1 units on a scale | Standard Deviation 7.8 |
| Genetic Feedback Plus Standard Treatment | Depression | 4.1 units on a scale | Standard Deviation 8.2 |
Secondary
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
Time frame: 12 weeks after Target Quit Date
Population: Follow-up psychological outcome analyses include only those participants not lost to follow-up (n = 30)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Treatment | Fatalism | 1.1 units on a scale | Standard Deviation 1.8 |
| Genetic Feedback Plus Standard Treatment | Fatalism | 0.4 units on a scale | Standard Deviation 1 |
Secondary
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
Time frame: Within 1 week of first clinical call
Population: First psychological outcome analyses include participants who received the first clinical call (n = 33)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Treatment | Intention to Quit | 18.3 units on a scale | Standard Deviation 2.9 |
| Genetic Feedback Plus Standard Treatment | Intention to Quit | 19.5 units on a scale | Standard Deviation 1.9 |
Secondary
Morisky Adherence Scale
Category: Treatment Acceptability Measures: Treatment Compliance Range: 0-8 Direction: Higher values represent higher compliance
Time frame: 12 weeks after Target Quit Date
Population: Follow-up treatment satisfaction analyses includes only those participants not lost to follow-up (n = 30)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Treatment | Morisky Adherence Scale | 2.7 units on a scale | Standard Deviation 1.9 |
| Genetic Feedback Plus Standard Treatment | Morisky Adherence Scale | 1.8 units on a scale | Standard Deviation 1.6 |
Secondary
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
Time frame: Within 1 week of first clinical call
Population: First psychological outcome analyses include participants who received the first clinical call (n = 33)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Treatment | Motivation | 6.2 units on a scale | Standard Deviation 1 |
| Genetic Feedback Plus Standard Treatment | Motivation | 6.4 units on a scale | Standard Deviation 0.73 |
Secondary
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
Time frame: Within 1 week of first clinical call
Population: First psychological outcome analyses include participants who received the first clinical call (n = 33)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Treatment | Perceived Control | 14.0 units on a scale | Standard Deviation 2.5 |
| Genetic Feedback Plus Standard Treatment | Perceived Control | 13.4 units on a scale | Standard Deviation 3.4 |
Secondary
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
Time frame: Within 1 week of first clinical call
Population: First psychological outcome analyses include participants who received the first clinical call (n = 33)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Treatment | Risk Perception | 15.3 units on a scale | Standard Deviation 2.8 |
| Genetic Feedback Plus Standard Treatment | Risk Perception | 16.1 units on a scale | Standard Deviation 2.5 |
Secondary
Satisfaction Scale
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
Population: First treatment satisfaction analyses include participants who received the first clinical call (n = 33)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Treatment | Satisfaction Scale | 19.4 units on a scale | Standard Deviation 1.8 |
| Genetic Feedback Plus Standard Treatment | Satisfaction Scale | 19.5 units on a scale | Standard Deviation 0.8 |
Secondary
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
Time frame: Within 1 week of first clinical call
Population: First psychological outcome analyses include participants who received the first clinical call (n = 33)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Treatment | Self-Efficacy | 16.2 units on a scale | Standard Deviation 2.5 |
| Genetic Feedback Plus Standard Treatment | Self-Efficacy | 15.6 units on a scale | Standard Deviation 2.6 |
Secondary
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
Time frame: Within 1 week of first clinical call
Population: First psychological outcome analyses include participants who received the first clinical call (n = 33)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Treatment | Threat Minimization | 8.9 units on a scale | Standard Deviation 2.9 |
| Genetic Feedback Plus Standard Treatment | Threat Minimization | 7.3 units on a scale | Standard Deviation 3.6 |
Secondary
Treatment Interest Scale
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
Population: First treatment satisfaction analyses include participants who received the first clinical call (n = 33)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Treatment | Treatment Interest Scale | 9.0 units on a scale | Standard Deviation 1.6 |
| Genetic Feedback Plus Standard Treatment | Treatment Interest Scale | 9.6 units on a scale | Standard Deviation 0.74 |
Secondary
Trust Scale
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
Population: First treatment satisfaction analyses include participants who received the first clinical call (n = 33)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Treatment | Trust Scale | 19.3 units on a scale | Standard Deviation 2.5 |
| Genetic Feedback Plus Standard Treatment | Trust Scale | 18.8 units on a scale | Standard Deviation 2.3 |