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| ID | Type | Description | Link |
|---|---|---|---|
| 5R21DA027331-03 | U.S. NIH Grant/Contract | View source | |
| Protocol # 16513 | Other Identifier | Stanford IRB |
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| Name | Class |
|---|---|
| SRI International | INDUSTRY |
| Johns Hopkins University | OTHER |
| University of Bristol | OTHER |
| National Institute on Drug Abuse (NIDA) |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard treatment | Active Comparator |
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| Genetic feedback plus standard treatment | Experimental | In addition to the standard treatment, participants in this arm received the following interventions:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Counseling | Behavioral | Three 20-minute telephone calls during which a certified tobacco treatment specialist delivered motivationally-enhanced cognitive behavioral counseling
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| 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 |
| 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 |
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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:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sean P David, MD SM DPhil | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SRI International | Menlo Park | California | 94025 | United States | ||
| Stanford University School of Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22949583 | Result | McClure JB, Swan GE, St John J, Fauver R, Javitz HS, Bergen AW, Nishita D, Niaura R, Munafo MR, David SP. Pharmacogenetic smoking cessation intervention in a health care setting: a pilot feasibility study. Nicotine Tob Res. 2013 Feb;15(2):518-26. doi: 10.1093/ntr/nts173. Epub 2012 Sep 4. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| FG001 | Standard Treatment | Received behavioral counseling by telephone and either bupropion or nicotine replacement patch |
| FG002 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Phase I, Formative Research |
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| Phase II, Randomized Control Trial |
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Treatment | Received behavioral counseling by telephone and either bupropion or nicotine replacement patch |
| BG001 | 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 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | All randomized participants were included in the data analysis. | Posted | Number | participants | 12 weeks after Target Quit Date |
|
2 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard Treatment | Received behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch |
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Possible selection bias as 32 of 36 participants had taken part in previous research
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sean P. David, MD, SM, DPhil | Stanford University | 650-498-4687 | spdavid@stanford.edu |
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| ID | Term |
|---|---|
| D012907 | Smoking |
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D015438 | Health Behavior |
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| ID | Term |
|---|---|
| D003376 | Counseling |
| D062405 | Motivational Interviewing |
| D004358 | Drug Therapy |
| D000095488 | Nicotine Replacement Therapy |
| D016642 | Bupropion |
| D000071185 | Pharmacogenomic Testing |
| ID | Term |
|---|---|
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
| D003153 | Community Health Services |
| D006296 | Health Services |
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| NIH |
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| Self-help guide | Behavioral | A printed self-help guide for smoking cessation (Clearing the Air, NCI)sent by mail |
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| Pharmacotherapy | Drug | 8-week course of genetically-tailored pharmacotherapy
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| Genetic feedback, verbal | Behavioral | During the first counseling call, GF participants were informed of their genotype and provided with the rationale for their pharmacotherapy assignment |
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| Genetic feedback, printed | Behavioral | 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. |
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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 |
| Stanford |
| California |
| 94305 |
| United States |
| Group Health Research Institute | Seattle | Washington | 98101 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | Morisky Adherence Scale | Category: Treatment Acceptability Measures: Treatment Compliance Range: 0-8 Direction: Higher values represent higher compliance | Follow-up treatment satisfaction analyses includes only those participants not lost to follow-up (n = 30) | Posted | Mean | Standard Deviation | units on a scale | 12 weeks after Target Quit Date |
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| Secondary | Trust Scale | Category: Treatment Acceptability Measures: Trust in the clinician Range: 5-30 Direction: Higher values represent higher trust | First treatment satisfaction analyses include participants who received the first clinical call (n = 33) | Posted | Mean | Standard Deviation | units on a scale | Within 1 week of first clinical call |
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| 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 | First treatment satisfaction analyses include participants who received the first clinical call (n = 33) | Posted | Mean | Standard Deviation | units on a scale | Within 1 week of first clinical call |
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| Secondary | Satisfaction Scale | Category: Treatment Acceptability Measures: Overall satisfaction with the clinician Range: 4-20 Direction: Higher values represent higher satisfaction | First treatment satisfaction analyses include participants who received the first clinical call (n = 33) | Posted | Mean | Standard Deviation | units on a scale | Within 1 week of first clinical call |
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| 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 | First treatment satisfaction analyses include participants who received the first clinical call (n = 33) | Posted | Mean | Standard Deviation | units on a scale | Within 1 week of first clinical call |
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| 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 | First psychological outcome analyses include participants who received the first clinical call (n = 30) | Posted | Mean | Standard Deviation | units on a scale | Within 1 week of first clinical call |
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| 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 | Follow-up psychological outcome analyses include only those participants not lost to follow-up (n = 30) | Posted | Mean | Standard Deviation | units on a scale | 12 weeks after Target Quit Date |
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| 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 | First psychological outcome analyses include participants who received the first clinical call (n = 33) | Posted | Mean | Standard Deviation | units on a scale | Within 1 week of first clinical call |
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| 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 | First psychological outcome analyses include participants who received the first clinical call (n = 33) | Posted | Mean | Standard Deviation | units on a scale | Within 1 week of first clinical call |
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| 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 | First psychological outcome analyses include participants who received the first clinical call (n = 33) | Posted | Mean | Standard Deviation | units on a scale | Within 1 week of first clinical call |
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| 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 | First psychological outcome analyses include participants who received the first clinical call (n = 33) | Posted | Mean | Standard Deviation | units on a scale | Within 1 week of first clinical call |
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| 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 | First psychological outcome analyses include participants who received the first clinical call (n = 33) | Posted | Mean | Standard Deviation | units on a scale | Within 1 week of first clinical call |
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| 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 | First psychological outcome analyses include participants who received the first clinical call (n = 33) | Posted | Mean | Standard Deviation | units on a scale | Within 1 week of first clinical call |
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|
| 0 |
| 17 |
| 0 |
| 17 |
| EG001 | Genetic Feedback Plus Standard Treatment | Received genetic feedback regarding treatment selection in addition to behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch | 0 | 19 | 0 | 19 |
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| D005159 | Health Care Facilities Workforce and Services |
| D037001 | Directive Counseling |
| D013812 | Therapeutics |
| D011427 | Propiophenones |
| D007659 | Ketones |
| D009930 | Organic Chemicals |
| D005820 | Genetic Testing |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
| D005821 | Genetic Techniques |
| D033142 | Genetic Services |
| D003954 | Diagnostic Services |
| D011314 | Preventive Health Services |