Toward the Implementation of Genomics in Substance Use Disorder Treatment
Phase: NA
Conditions: Tobacco Use Disorder, Smoking Cessation, Tobacco Use Cessation
Sponsor: Washington University School of Medicine

Title:   
Toward the Implementation of Genomics in Substance Use Disorder 
Treatment 
 
 
Protocol ID#   
201704049 
 
NCT#  
 
NCT04768114 
 
Date:  
 
11/06/2023 
 

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Genomics Implementation in SUD
PI:
Alex Ramsey
IRB ID #: 201704049
Project Details
1. Demographics
1.1
Project Title:
Toward the Implementation of Genomics in Substance Use Disorder Treatment
1.2
Short Title (required):
Genomics Implementation in SUD
1.3
Project is primarily:
Biomedical
1.3.a
Does this study require review under ICH-GCP?
No
1.4
Type of Study:
Other Interventional
1.4.a
Is your research study one in which one or more human subjects are prospectively assigned to one or more
interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-
related biomedical or behavioral outcomes (NIH clinical trial definition).
Yes
1.5
Select how you plan to obtain consent:
•  Sign a consent document or a consent letter
•  Letter or information sheet with no signature
•  Script for use either in person or over the phone with no signature
2. Source(s) of Support
2.1
Source(s) of Support
Type/Source
Grant Title
Name of PI
on Grant
Status
WUSTL Awardee
Institution
Federal Agency
NIH, National
Institutes of Health
Washington University Career Development
Program in Drug Abuse and Addiction
Laura Bierut
AWARDED
Yes
Federal Agency
NIH, National
Institutes of Health
Mechanisms of Behavior Change in a
Genetics-Informed Smoking Cessation
Intervention
Alex Ramsey
AWARDED
Yes
Attachment Name
Category
Version
Date Attached
K12_submitted_grant_HRPO.pdf
Grant from funding source
or private
foundation/association
1
05/05/17
K12_final combined.pdf
Grant from funding source
or private
foundation/association
1
05/05/17
3. Research Team
3.1
Principal Investigator
Name
E-mail
Title
Alex Ramsey
aramsey@wustl.edu
Assoc Prof of Psychiatry
3.2Team Members
Research Team Members
Role
Name
Role Desc
Student
Email
Title
School

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PI
Alex Ramsey, BS, PhD, MA, BS, MA, PHD
No
aramsey@wustl.edu
Assoc Prof
of
Psychiatry
School of
Medicine
Laura Bierut, MD
laura@wustl.edu
Alumni
Endowed
Prof of
Psychiatry
School of
Medicine
Yoonhoo Chang, BS
No
yoonhoochang@wustl.edu
DBBS
Graduate
Research
Asst
School of
Medicine
Jingling Chen, BS
No
chenjingling@wustl.edu
Statistical
Data
Analyst
School of
Medicine
Li-Shiun Chen, ScD, MD, MPH
li-shiun@wustl.edu
Prof of
Psychiatry
School of
Medicine
Sherri Fisher, MS
No
sherri@wustl.edu
Clinical
Research
Specialist
School of
Medicine
Louis Fox, BS
No
foxl@wustl.edu
Research
Statistician
School of
Medicine
Anastasia Hanonick, BA, Psychology
No
hanonick@wustl.edu
Professional
Rater II
School of
Medicine
Elizabeth Laurentius, BS, Psychology
No
laurentius@wustl.edu
Professional
Rater II
School of
Medicine
Giang Pham, MPH
No
g.pham@wustl.edu
Statistical
Data
Analyst
School of
Medicine
Enola Proctor, PHD
ekp@wustl.edu
Research
Professor
Brown
School
Thuelfaqar Rammaha, MS
No
r.thue@wustl.edu
Clinical
Research
Coordinator
II
School of
Medicine
Patricia Salyer, M.Ed., MA
No
salyerp@wustl.edu
Clinical
Research
Supervisor
School of
Medicine
Elizabeth Sekarski, BS, Psychology
No
esekarski@wustl.edu
Professional
Rater II
School of
Medicine
Kristen Sextro, BA
No
sextro@wustl.edu
Clinical
Research
Coordinator
I
School of
Medicine
Nina Smock, BA
No
smockn@wustl.edu
Clinical
Research
Specialist
School of
Medicine
Alia Thomas, High School
No
a.a.thomas@wustl.edu
ARTS AND
SCIENCES
Lauren Waight, BA
No
lwaight@wustl.edu
Professional
Rater II
School of
Medicine
Erika Waters, MPH, PHD
No
waterse@wustl.edu
Prof of
Surgery
(Public
Health
Sciences)
School of
Medicine
LA
Jessica Bourdon, PHD
Jessica
Bourdon is
the Director
of Research
Administration
at Wellbridge
Addiction
Treatment
and Research.
She
completed her
post-
doctorate at
Washington
University and
has played a
key role in
this research
for several
years. She
No
jbourdon@wellbridge.org

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will be
responsible
for consenting
and
conducting
focus groups
for Aim 2 of
the study with
patients and
clinicians at
Wellbridge.
These focus
groups will be
conducted at
Wellbridge.
She will also
be involved in
assisting with
publications
resulting from
this work.
Jessica will
transfer the
data collected
from the
focus groups
through
WUSTL Box
where it will
be securely
stored.
LA
Genevieve Slavens, AA
Genevieve will
be trained to
conduct
recruitment
calls and
administer a
brief phone
follow-up.
After training,
she will
complete calls
and phone
follow-ups
under
supervision of
a member of
the research
team.
No
gslavens@email.wustl.edu
Team Member Financial Interest
Name
Financial Interests
Alex Ramsey, BS, PhD, MA, BS, MA, PHD
none
Laura Bierut, MD
none
Yoonhoo Chang, BS
none
Jingling Chen, BS
none
Li-Shiun Chen, ScD, MD, MPH
none
Sherri Fisher, MS
none
Louis Fox, BS
none
Anastasia Hanonick, BA, Psychology
none
Elizabeth Laurentius, BS, Psychology
none
Giang Pham, MPH
none
Enola Proctor, PHD
none
Thuelfaqar Rammaha, MS
none
Patricia Salyer, M.Ed., MA
none
Elizabeth Sekarski, BS, Psychology
none
Kristen Sextro, BA
none
Nina Smock, BA
none
Alia Thomas, High School
none
Lauren Waight, BA
none
Erika Waters, MPH, PHD
none
Jessica Bourdon, PHD
none
Genevieve Slavens, AA
none

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4. Other Institutional Reviews/Requirements
4.1
Do any of the objectives of this study involve the diagnosis, prevention, screening, evaluation, treatment or support of
cancer patients?
Yes
4.2
Are more than 30% of the patients involved in this study likely to have an active cancer diagnosis?
No
4.2.a
Is this application for treating a single patient without the goal of publication?
No
4.3
Will any subject be asked to undergo a radiation therapy procedure (including external beam therapy, brachytherapy, or
radiopharmaceutical therapy)?
No
4.4
Does your study involve the administration of non therapeutic radiopharmaceuticals (radioactive drugs) for research
purposes?
No
4.5
Will any participant be asked to undergo any of the following:
a standard radiology procedure involving ionizing radiation (includes X-rays, fluoroscopy, DEXA, CT)
OR
a standard nuclear medicine examination with FDA-approved radioactive drugs (including bone scans, radionuclide
ventriculogram (RVG or MUGA), myocardial perfusion imaging, FDG-PET)
DO NOT include a nuclear medicine examination performed with the investigational radioactive drug(s)
listed above in Question 4.4.
DO NOT include MRI or ultrasound
No
4.6
Will the study involve any of the following activity PROSPECTIVELY at WUSM or any BJC hospitals, even if subjects or
their insurance will not be billed for the item or service, and regardless of the study funding source (including studies
with departmental or no funding)?
Procedures, tests, examinations, hospitalizations, use of Pathology, Laboratory, Cardiology, or Radiology services,
use of clinic facilities or clinical equipment, or any patient care services, including services conducted in the Clinical
Research Unit; or
Physician services or services provided by non-physicians who are credentialed to bill (ARNPs, Physician Assistants,
etc.)
No
4.7
Does this study involve administration of recombinant or synthetic nucleic acids (gene therapy or mRNA vaccines) or
microorganisms?
No
4.8
Does this study involve the use of human embryonic stem cells or human induced pluripotent stem cells?
No
4.9
Does this study involve research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected
to risk of injury or death greater than that allowed for research on fetuses in utero?
No
4.12
Will a Certificate of confidentiality be used for this research?
Yes, certificate automatically issued by funding agency
4.13
Does this project need to be registered on ClinicalTrials.gov?
No
4.14
Title that should appear in Epic (and will be visible in the patient medical record):
Genetics & Smoking Study
4.15
Select one person from the study team that should appear in Epic as the contact person for this study:
Alex Ramsey
4.17
Would you like to submit a request for the Epic team to consider your study for the use of BPA (Best Practice Advisory)
in Epic?
No
4.18
Would you like to submit a request for the Epic team to build your questionnaires in Epic for the purposes of
recruitment?
Yes

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4.19
Will any external monitors require access to this study in Epic?
No
4.21
Mark all that apply to your study:
Mark any service(s) you'd like to use:
 • Participant Recruitment Services available through Recruitment Enhancement Core (REC)
 • Participant Recruitment Services available through Community Based Recruitment and
Retention (REACH)
1. Protocol
1.1
Is there a separate, written protocol that will be submitted in addition to this form? (Note: a grant application is not
considered to be a protocol)
No
1.2
Select up to three key words below that best describe this research study:
•  Genetics and Genomics
•  Psychiatry
•  Public Health
1.3
Provide a short summary/abstract of the purpose and procedures of the study proposed in this IRB application.
DO NOT include information on studies not proposed in this application.
Use LAY terminology only. This must be easily understandable by IRB community members and nonscientists.
DO NOT cut and paste technical abstracts from source of support applications that may not be understood by a
general audience.
The overall goal of this project is to conduct early-stage implementation research to (1) establish the feasibility of
returning genomic results to patients and providers in clinical and community settings and (2) pilot test novel
implementation strategies for integrating genomic applications for smoking cessation treatment in clinical care. The use
of personal genomic results to inform treatment has great potential to advance precision medicine efforts, and emerging
genomic discoveries, such as the ability to predict smoking-related disease risk and treatment responsiveness, may soon
be primed for implementation into community and routine care settings. Pre-implementation research is thus urgently
needed to identify and address anticipated barriers at the patient (concerns of genomic profiling) and physician
(resistance to change) levels that might thwart implementation and, as a result, the public health impact of genomic
advances in community and clinical care settings. Through both quantitative and qualitative interviews to address these
potential barriers, we will further advance the field toward appropriate implementation of genomic applications in routine
settings.
This study has two parts (Aim 1 and Aim 2). Aim 1: Examine the acceptability and effect of personalized genomic results
on smoking behaviors in different subgroups of adult smokers. As an important pre-implementation step, we will
examine the extent to which smokers in the community (1) agree to genetic testing, (2) recall details of their
personalized genomic results, and (3) change their smoking behaviors following review of their results. We will give
particular attention to potential differences in outcomes between subgroups, including African Americans and European
Americans. Aim 2: Pilot test implementation strategies for integrating genomics of smoking cessation treatment in
clinical care. The purpose of this aim is to pilot test two strategies--patient-mediated and provider-focused return of
results prior to clinical encounters--and begin to track implementation outcomes of incorporating patients’ personal
genomic information into smoking cessation treatment plans. We will collect data for Aim 1 first. Once the initial
evaluation of Aim 1 results is performed we will submit a modification to add Aim 2 to the study, or alternatively, once
the initial evaluation of Aim 1 results is performed we will submit a separate application to conduct Aim 2.
As a next step for Aim 1 in the context of COVID-19, we will conduct a fully-remote, pilot randomized controlled trial via
telehealth to (1) test the preliminary effects of the genetically-guided RiskProfile compared to brief cessation counseling,
and (2) assess the feasibility and acceptability of genetically-guided smoking cessation via telehealth.
For Aim 1, we will also re-consent participants by phone using the attached verbal script to complete a brief 10-15
minute phone follow-up approximately 18 months after their intervention to see if changes in attitude and behavior as a
result of receiving their personalized genetic results profile have persisted.
1.4
Specify your research question(s), study aims or hypotheses:
Aim 1: Examine the acceptability and effect of personalized genomic results on smoking behaviors, also referred to
as the RiskProfile, in different subgroups of adult smokers. As an important pre-implementation step, we will
examine the extent to which smokers in the community (1) agree to genetic testing, (2) recall details of their
personalized genomic results, and (3) change their smoking behaviors following review of their results. We will give
particular attention to potential differences in outcomes between subgroups, including African Americans and
European Americans. We will also examine potential mechanisms of behavior change, including health-related
cognitions and engagement, that may explain the observed outcomes (acceptability and effect of the RiskProfile).
Aim 2: Adapt the RiskProfile and evaluate feasibility and acceptability for use in real-world community settings. In
this mixed methods approach, we will aim to conduct an iterative process of data collection and adaption to
determine the feasibility of delivering the RiskProfile in a real-world setting. There are two data sources that will
inform the adaptation of the RiskProfile: 1) adapting for internal validity, using evidence from Aim 1 on potential
mechanisms that may identify elements that need to enhance potency of the intervention, and 2) adapting for

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external validity, using focus group feedback from a sample representing patient and provider viewpoints on
necessary modifications to the RiskProfile for use in a community health agency setting.
Feasibility of delivering the adapted RiskProfile will be determined by conducting a small-scale feasibility trial among
current smokers using structured interviews and quantitative metrics to examine the extent to which the RiskProfile
is translatable to real-world community settings. We hypothesize that successful completion of this aim will generate
feasibility and acceptability data that will support standardized use of the RiskProfile by community-based providers
in real-world settings.
1.5
Background and significance and/or Preliminary studies related to this project:
C. SIGNIFICANCE
C1. Substance use disorders, including tobacco use disorders, are a major public health problem. Tobacco use
remains the largest cause of preventable death in the United States, contributing to chronic obstructive pulmonary
disease, myocardial infarction, at least 14 types of cancer, and numerous other medical illnesses.55–57 Harmful
effects of smoking cost the United States more than $200 billion each year in health and productivity-related costs
and will eventually kill half of those who regularly use tobacco.58 There are several evidence-based
pharmacotherapies for smoking cessation—including varenicline, nicotine-replacement therapies, and bupropion—
and 70% of smokers currently want to quit.59–61 Nevertheless, sustained patient engagement and adherence to
treatment are low,61,62 and only about 5% of smokers are able to successfully quit smoking,61 suggesting the need
for improved personalized smoking cessation treatment protocols.63
C2. Genomic data predict heaviness of smoking, risk of smoking-related diseases, and effect of smoking cessation
pharmacotherapy. Similar to genomic advancements in other fields, genomic information may be instrumental to
recovery of tobacco use disorder and other substance use disorders (SUD).58,62–65 In fact, genomic data have
been shown to predict smoking heaviness, smoking-related disease risk, likelihood of smoking cessation, and
responsiveness to smoking cessation treatments.26–35 For instance, smokers with high-risk genomic variants in the
CHRNA5 nicotinic receptor gene were far less likely to successfully abstain from smoking than those with low-risk
genotypes. Additionally, while smokers with high-risk genotypes responded to pharmacologic cessation treatments
with a two-fold increase in abstinence, those with low-risk genotypes did not benefit from pharmacotherapy.26,27
Effective translation of these genomic findings may be critical to engaging high-risk patients and informing the most
appropriate treatment approaches for smoking cessation.58,62,63 Within the SUD field, given that the science of
genomic discovery is farthest along with respect to tobacco use disorder, the current research project focuses on the
role of genomic medicine for smoking cessation.
C3. Genomic advancements will increasingly provide opportunities to personalize care for SUD. The Precision
Medicine Initiative has sparked a new era of medicine in which data on genomics and patient preferences are being
used to better engage individuals, inform decision-making, and personalize treatment for a wide range of
diseases.37,42–46 This proposal aims to prepare the SUD field for the phenomenon referred to as “the unstoppable
march of genomics into clinical practices.”66 The integration of genomic medicine into practice is still in its infancy,
and countless scientific discoveries will continue to advance and refine our understanding of the role of genomic data
in clinical care.23 However, the unprecedented potential of genomic data to engage populations and inform SUD
treatment demands timely conduct of “early stage” implementation studies such as the one currently
proposed.58,62 Assessing the feasibility of returning genomic results for SUD in multiple contexts (community,
clinical) and pilot testing potential implementation strategies will generate long-range, translatable findings that will
greatly benefit the field as genomic medicine continues to advance.
C4. Implementation science offers valuable approaches for bringing genomic medicine to clinical care. Despite the
potential of genomic medicine to radically improve patient engagement and treatment for SUD, there has been a
notable lack of implementation research on the use of rapidly-emerging genomic discoveries for improved clinical
care.47,58,62,64 Implementation research has traditionally focused on long-established and well-validated
interventions. However, the often-cited 17-year delay in translating research to practice54,67–69 necessitates an
aim to better understand the process of implementing new classes of rapidly-emerging innovations (e.g., genomics)
—an approach essential to narrowing the vast translational gap.54,70,71 The NIH-funded Implementing Genomics in
Practice consortium has begun to demonstrate the useful role of implementation science in preparing the medical
field to integrate genomics into clinical diagnosis and treatment.49 The use of implementation science theory (e.g.,
Consolidated Framework for Implementation Research),49,72,73 implementation outcomes such as adoption (actual
utilization) and acceptability (favorable attitudes) of evidence-based innovations,74,75 and implementation
strategies (e.g., clinical decision support systems)76,77 have proven valuable in increasing the readiness of the field
to implement genomics to improve clinical care of other chronic diseases. This value may translate to the field of
SUD as well; however, the proposed research is needed given the unique challenges of implementing new
innovations in the SUD field.78
Preliminary Findings. Prior research led by Dr. Laura Bierut’s team at WU and replicated by others has demonstrated
that variation in the nicotinic cholinergic receptor subunit gene CHRNA5 (particularly rs16969968) and nicotine
metabolism predict risk of tobacco use disorder and developing smoking-related diseases including lung cancer and
chronic obstructive pulmonary disease.30–33,37,38,90–92 Studies indicate that variants in the CHRNA5 gene also
predict delayed smoking cessation26 and more favorable response to pharmacological treatment and success of
pharmacotherapy for smoking cessation.27,34,35,93–95 While the evidence base in genomics for smoking cessation
and SUD continues to develop, these findings constitute important discoveries that are not yet being incorporated
into clinical care or public health programs. Dr. Bierut’s team also found that by returning genetic results to smokers,
smoking cessation attempts increased from 21% at baseline to 53% after 4 to 8 weeks96 and, importantly, did not
lead to “false reassurance” or increased risk of smoking in former or non-smokers.97 Large strides in implementing
genomics have been made in other fields, including oncology, and these efforts have resulted in a growing bank of
instruments and other research materials. These resources provide a much-needed foundation by which other fields,
including SUD, can begin to study the integration of genomic discoveries in clinical care and other settings. The
current research aims are built on this existing infrastructure which enhances the feasibility of the study. However,
this study explores new research questions within the unique and different field of a behavioral disorder, thereby
contributing to the rapidly developing science of implementing genomic findings into diverse settings.
1.6
Literature cited/references (if attaching a grant enter N/A):

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N/A
1.7
Describe EACH of your participant populations
Include description of any control group(s)
Specify the Inclusion/Exclusion criteria for EACH group
AIM 1:
For the Aim 1 lab-based study, participants will include adults who are current smokers of tobacco. Participants will
primarily be located in the Greater St. Louis Area; however, in the event of recruitment challenges, participants may be
geographically dispersed throughout the United States. Subjects cannot have a condition that prevents them from
providing informed consent or effectively participating in the protocol (e.g., language difficulty, central nervous system
damage, or extremely poor health).
For the Aim 1 campus-based study, participants will include adult pedestrians in various parts of WUSM and Danforth
campuses. Participants may include healthcare professionals, academicians, students, patients, or other members of the
public. Subjects cannot have a condition that prevents them from providing informed consent or effectively participating
in the protocol (e.g., language difficulty, central nervous system damage, or extremely poor health). As part of this
study, will also enroll participants who work at the National Council on Alcoholism and Drug Abuse – St. Louis Area
(NCADA). These participants will predominantly consist of substance abuse counselors.
AIM 2:
For Aim 2, participants will include adults who are current tobacco smokers and clinicians and peer support specialists in
a partnering community health agency (Wellbridge Addiction Treatment and Research). Two focus groups will be
conducted: one with current smokers who are inpatient at Wellbridge (n=20) and one with clinicians and peer support
specialists (n=10) at Wellbridge. Each group will be engaged in qualitative interviews to address the feasibility and
acceptability of the content and format of the adapted RiskProfile. These focus groups will be led by a member of the
research team.
To test the feasibility of delivering the RiskProfile in a real-world community setting, a second group of current smokers
(n=25) and peer support specialists (n=10) will be invited to participate in a small-scale feasibility trial that will involve
current smokers getting genetic testing while they are inpatient at Wellbridge and then receiving their their RiskProfile
via Zoom after they are discharged. The RiskProfile will be delivered by their peer support specialist under the
supervision of the research team.
Inclusion/exclusion criteria for individuals in the patient focus group are below.
Inclusion criteria: Past 30-day use of combustible cigarettes, patient in rehabilitation within addiction treatment center
Exclusion criteria: Primarily vaping, in detoxification unit of addiction treatment center, participation in a previous focus
group for this study (if re-admitted)
Inclusion/exclusion criteria for current smokers in the feasibility trial are below.
Inclusion criteria: Past 30-day use of combustible cigarettes, patient in rehabilitation within addiction treatment center
Exclusion criteria: Primarily vaping, in detoxification unit of addiction treatment center
Individuals in the clinician focus group or in the clinician group in the feasibility trial must be currently employed
clinicians or peer support specialists at Wellbridge Addiction Treatment and Research.
1.8
Check all materials/methods that will be used in recruiting participants:
•  Ads/Brochures/Posters/News Release/Fliers
•  Email or letters
•  Other Research Study  -  COGA subjects (IRB ID 201105402) and GISC subjects (IRB ID 201305128)
•  Existing Registry/database  -  Research Participant Registry (RPR) and ResearchMatch through Volunteer for Health -
Recruitment methods through VFH include posting ads on Centerwatch (www.centerwatch.com), RPR Fan Page listing on
Facebook, and an RPR database query for referrals who have self-identified as current smokers. The RPR database is a
HIPAA approved, secure database of consented potential participants that have expressed interest in getting contacted
about currently enrolling Washington University clinical trials.
•  Word of Mouth/Snowball sampling
•  Medical Records or Other PHI
•  Epic - MyChart
•  Other Methods/Source  -  ResearchMatch.org will be utilized as a recruitment tool for this protocol. ResearchMatch.org
is a national electronic, web-based recruitment tool that was created through the Clinical & Translational Science Awards
Consortium in 2009.
Attachment Name
Category
Version
Date Attached
Red Poster (2).rtf
Recruitment Materials:
Ads/Brochures/Posters/News
Release/Fliers
5
07/09/21
Ramsey 201704049 -
Centerwatch_TS edits.rtf
Recruitment Materials:
Ads/Brochures/Posters/News
Release/Fliers
1
07/05/19
mailed recruitment letter.rtf
Recruitment: Email or letters
1
06/20/19
Feasibility Clinician
Recruitment Flyer.pdf
Recruitment Materials:
Ads/Brochures/Posters/News
Release/Fliers
1
07/14/23
Ramsey 201704049-
Facebook_TS edits.rtf
Recruitment Materials:
Ads/Brochures/Posters/News
Release/Fliers
1
07/05/19

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Wellbridge Clinician Flyer
Final.pdf
Recruitment Materials:
Ads/Brochures/Posters/News
Release/Fliers
1
10/07/22
Wellbridge Inpatient
Flyer_FINAL.pdf
Recruitment Materials:
Ads/Brochures/Posters/News
Release/Fliers
1
10/07/22
Grey Poster (1).rtf
Recruitment Materials:
Ads/Brochures/Posters/News
Release/Fliers
5
07/09/21
GENIMP_V5 recruitment
letter_4-6-2023.docx
Recruitment: Email or letters
1
04/07/23
Feasibility Patient
Recruitment Flyer.pdf
Recruitment Materials:
Ads/Brochures/Posters/News
Release/Fliers
1
07/14/23
ResearchMatch Contact
Message.docx
Recruitment: Email or letters
2
08/28/20
Study name and description
for MyChart.docx
Recruitment: Email or letters
2
08/28/20
201704049 VHF Recruitment
Flyer_12-21-21.rtf
Recruitment Materials:
Ads/Brochures/Posters/News
Release/Fliers
3
12/23/21
email correspondence_v5.rtf
Recruitment: Email or letters
9
06/28/21
Recruitment Letter_for
recruiting from GISC_v2.rtf
Recruitment: Email or letters
3
08/16/19
V5 follow-up Flyer4.pdf
Recruitment Materials:
Ads/Brochures/Posters/News
Release/Fliers
1
08/23/23
1.8.b
List the individual data elements you will access from the medical records (or other source of PHI) to identify potential
participants for recruitment and, if applicable, any individual data elements that you will include on a screening log prior
to consent.
We will be recruiting participants from COGA and GISC who smoke and will need to obtain identifiable health information
for recruitment purposes. To identify potential participants for recruitment, we will access and use self-reported past
month smoking and breath carbon monoxide levels from their previous records.
We will also filter results by age and current smoking status from Epic/MyChart, RPR, and ResearchMatch to identify
potential participants for recruitment.
1.8.c
What is the plan for individual identifiers obtained to identify participants and, if applicable, those identifiers maintained
on a screening log prior to consent?
Identifiers for both those who enroll and those who do not enroll will be retained beyond the period of recruitment and
enrollment of participants
• Data analysis/verification
• Long term follow-up
• Linking to other data
1.8.d
Does the research team agree that the requested information will not be reused or disclosed to any other person or
entity, except as required by law, for authorized oversight of the study, or for other research for which the use or
disclosure of the requested information would be permitted by the HIPAA Privacy Rule?
Yes
1.10
Describe where the consent discussion will occur (check all that apply):
•  Private room or area
•  By phone
•  Online
1.11
Participants and/or their legally authorized representative will have (check all that apply to the consent process and
explain process in Question 1.12 below):
•  As much time as they desire to consider enrolling in the study, including:
An opportunity to thoroughly review the consent materials with knowledgeable members of the research team,
and with family and/or friends as appropriate
Sufficient time to have all of their questions answered
1.12
Provide a description of the enrollment and consent process in sequential order and address EACH of the bulleted points
below:
Describe each study population separately including control population
Describe when recruitment and consent materials are used
Indicate how much time individuals will have to consider participation
If eConsent will be used to obtain an electronic signature, describe how the eConsent will be presented to
participants, how their questions will be answered and how the participant will receive a copy of the final, signed

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consent
Describe the steps that will be taken by the research team to minimize the possibility of coercion or undue influence
during the consent process
For Aim 1, participants will include approximately 250 adults who are current smokers from the Greater St. Louis Area.
The research team will recruit subjects from the existing COGA study (IRB ID 201105402) and GISC study (IRB ID
201305128), including only those who are current smokers, and will also Epic/MyChart and work with Volunteer for
Health (VFH) to identify and enroll individuals who are current smokers and at least 18 years of age. Participants can
search for and volunteer to be enrolled in this study or may be identified as potentially eligible for this study. Through
word-of-mouth, participants may also provide us with contact information for others who may be interested in
participating. Once identified, the principal investigator will send the postal mail recruitment letter or email recruitment
letter to potential participants who can then contact the research team to find out more about the study and set up an
in-person or electronic consent (e-Consent) and screening visit or phone call, as desired. Informed consent will be
obtained from all subjects by a trained research assistant. E-Consent will be conducted in REDCap, and we will email to
the participant a link to the e-Consent to complete. Participants will be able to download or print a copy of the consent
from REDCap. Participants will have the option to receive a signed copy of their consent emailed to them by the research
team via REDCap. During the in-person consent visit or e-Consent, participants will be provided with a copy of the
consent form for review and given the opportunity to ask questions prior to agreeing to participate. Participants will be
assured that they can choose not to participate or can discontinue participation at any time without losing any benefits
for which they would otherwise qualify. Participants for this study will also be invited to consent to be enrolled in the
ICTS Genomic Database Protocol (IRB# 201902019). This protocol allows their genetic data, research data and
electronic health care data to be placed in the ICTS Genomic Database for future research. Details for the ICTS Genomic
Database Protocol are provided in the ICTS Genomic Database IRB.
For the brief V5 follow-up, we will reach out to participants by email, mail, and phone to re-engage participants in
completing the phone call visit. Participants will be consented by phone using the Genimp phone consent (attached for
review). A member of the research team will review the consent with the participant, answer any questions they have,
and ask for their verbal consent to participate in the visit.
As a developmental activity prior to the above research study, two research team members will use a brief script to
engage with a convenience sample of individuals walking through various areas of campus, as well as in brief
interactions with staff members (e.g., substance abuse counselors) who work at the National Council on Alcoholism and
Drug Abuse – St. Louis Area (NCADA). Interactions with NCADA staff may instead take place in meeting rooms at
NCADA or at Washington University. We will request that individuals spend 30-60 seconds giving feedback on the design
and formatting of a sample template of the personalized genomic results profile, or report card (see attachments). The
goal is to maximize clarity, simplicity, appeal, and usefulness of the report card for future participants. We will conduct
this activity by setting up a table for people to walk up to, as well as a more mobile, free-range approach of walking
around to solicit feedback from other individuals on campus. Participants of this brief activity may include healthcare
professionals, academicians, students, patients, or other members of the public. This activity will take place
intermittently at various times for up to 6 hours per week for up to 3 weeks, until saturation of design-related themes is
reached. The brief script will be used to request participation, and if individuals decline or do not show interest in
participating, they will simply be thanked for their consideration.
Participants will include a group of current smokers (n=20) and a group of clinicians and peer support specialists (n=10)
in a partnering community health agency (Wellbridge Addiction Treatment and Research). The current smokers will be
adults who are inpatient at Wellbridge for substance abuse treatment and the clinicians will be substance abuse
counselors who work at Wellbridge. The peer support specialists will include former Wellbridge clients who have
successfully maintained their sobriety and now assist with treatment of new patients. A member of the research team
will recruit participants for the study by posting flyers (attached for review) at Wellbridge Treatment Center. One poster
will be targeted for recruitment of patients who are current smokers and the other will be targeted for clinicians.
Individuals interested in participating will be instructed to contact the research team to sign up. The research team
member will make it clear that participation in the study is completely optional and is not a requirement of the treatment
program and that they can stop their participation at any time. For potential participants who are patients, a member of
the research team will verify that they are a current smoker at this time. For potential participants who are patients, a
member of the research team will ask them a couple screening questions to verify that they are a current tobacco
smoker at this time. Potential participants will be given as much time as they need to decide about participation.
Individuals who are interested in participating will then be scheduled for a focus group by a member of the research
team.
Prior to the focus group, a member of the research team will provide participants with an information sheet (attached)
that describes the main points of the study and what participation involves. Participants will then have the opportunity to
ask the research team member any questions they have prior to participating.
For the Aim 2 small scale feasibility trial, current smokers (N=25) and counselors or peer support specialists (n=10) will
be recruited and enrolled from the Wellbridge Treatment Center using the procedures described above. Individuals who
are interested in participating will be asked to contact a member for the research team. Prior to participation in the small
scale feasibility trial, a research team will obtain consent from current smokers at Wellbridge Treatment center using a
paper copy of the consent. During the consent process, current smokers will be provided with a copy of the consent form
for review and given the opportunity to ask questions prior to agreeing to participate. Current smokers will be assured
that they can choose not to participate or can discontinue participation at any time without losing any benefits for which
they would otherwise qualify and that their participation in the study is completely voluntary. A signed copy of the
consent will be provided to current smokers. Counselors and peer support specialists will be provided with a copy of the
clinician consent form to review and given the opportunity to ask questions before being asked to sign.
1.13
Provide a detailed description in sequential order of the study procedures following the consent process - DO NOT cut
and paste from the Consent Document.

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Describe study populations separately if they will be participating in different procedures
DESCRIBE:
Control populations, if applicable
Any randomization, if applicable
What participants will be asked to do/what happens in the study (in sequential order)
The time period over which procedures will occur
Long-term follow-up and how it occurs
For Aim 1, via in-person or remote (phone or Zoom) interviews, we will ask baseline questions about smoking behaviors
and genetic knowledge and then offer genetic testing to the participant. As an objective measure of acceptability, we will
track the proportion of eligible participants who decline the genetic testing; this will inform how many individuals must
be targeted to achieve desired samples in future research. This interview will take approximately 20 minutes. During the
in-person visit, participants will contribute DNA via saliva sample; during remote visits, participants will contribute DNA
via saliva sample using a 23andMe kit that was mailed to them. We will give each participant a tube to collect each
saliva sample. Participants will spit into the tube until there is enough saliva in the tube. This typically takes 1 to 5
minutes. The research team (for in-person visits) or the participant (for remote visits) will send the saliva samples to
23andMe for genetic testing and analysis in a CLIA certified laboratory. Saliva samples sent to 23andMe will be
registered via an on-line account created by the participant on the 23andMe website using their personal email address.
Participants must provide first and last name, sex and date of birth to register their saliva sample. During the in-person
or remote visit, participants will register their sample with 23andMe, including ancestry and health information, and will
authorize the research team to receive their results but will not automatically agree to other research through 23andMe.
A member of the research team will assist participants in creating an online account through the 23andMe website.
Participants can choose whether or not they want 23andMe to store their saliva sample. A member of the research team
will show participants this option on the 23andMe website while helping them to register their sample. We will ask
participants to log into their 23andMe account and give permission for the research team to download their genetic data
and use it for research purposes. We will use these data to create a personalized genetic profile (RiskProfile) specific to
participants' smoking-related genetic risk and likely responsiveness to medication. The data used for genomic profiles
that we will create are part of the standard data generated by 23andMe. We will then randomize participants to one of
two groups--Intervention (receive RiskProfile) or Control (receive brief cessation counseling and then receive RiskProfile
at end of study)--and ask participants to return for a separate in-person or remote visit to receive their personalized
genetic profile or brief cessation counseling and respond to the interview questions during that in-person or remote visit.
The personalized genetic profile will be referred to as a genetics-informed "RiskProfile" and was refined through the
developmental/design-oriented study with multiple stakeholder groups. Depending on the specific genetic profile of the
participant, the RiskProfile will slightly differ; for example, for some, it will say "at very high risk", for some, it will say
"at high risk", and for some, it will say "at risk". This will enable us to receive important feedback about the return of
results procedure within the context of recently receiving personalized genetic results profile. These participants will then
be asked to participate in a 30-day follow-up and then a 6-month follow-up, both comprising a 20-minute interview by
phone or Zoom to examine changes in attitude and behavior as a result of receiving their personalized genetic results
profile. Control group participants will receive their RiskProfile during the 6-month follow-up assessment. For the remote
study, each participant's unique RiskProfile will be stored in the participant's unique folder on WUSTL Box platform and
viewable to that participant and the research team only. Participants will also be asked to do a brief 10-15 minute phone
follow-up approximately 18 months after their intervention to see if changes in attitude and behavior as a result of
receiving their personalized genetic results profile have persisted.
Interviews will be audio recorded, and both audio and video recorded for Zoom interviews, for purposes of quality
monitoring and assurance and to serve as a backup in case of technical difficulties (e.g., data entry software crash)
during the interview that would risk data loss.
For the developmental activity to gather design-related feedback on the report card template, we will ask participants to
review the report card and then share ideas on the clarity, simplicity, appeal, and usefulness of the sample report card,
as well as how the design or formatting could be improved. Finally, we will ask a non-identifying question about whether
the individual is a professional in the medical field and, if so, their general role in this field.
These campus-based interactions and interactions with NCADA staff (e.g., substance abuse counselors) will not be audio
recorded.
Description of 23andMe and 23andMe Service: 23andMe, Inc. is a leading personal genetics company. Founded in 2006,
the mission of the company is to help people access, understand and benefit from the human genome. The 23andMe®
Service is a genetic service available directly to customers. The 23andMe Service includes personalized genetic reports
that meet FDA standards for being scientifically and clinically valid and access to proprietary interactive tools to share,
compare and discover with family and friends. The service is not intended to diagnose any disease. As noted in the
23andMe Privacy Statement (www.23andme.com/about/privacy/), 23andMe employs software, hardware and physical
security measures to protect the computers where customer data is stored, as well as robust authentication methods to
access their systems. 23andMe customers’ personal information and genetic data are stored in physically separate
computing environments, which is in line with the industry standards for security.
AIM 2:
For Aim 2, we will engage current smokers (n=20) and clinicians and peer support specialists (n=10) in a partnering
community health agency (Wellbridge) to adapt the RiskProfile for use in real-world community-based settings. Focus
groups and participatory design activities will be used to guide the adaptation of the existing RiskProfile. We will conduct
two focus groups with current smokers and counselors each to garner additional feedback on the RiskProfile
intervention. Focus groups will attend to the feasibility and acceptability of the content and format of the version of the
intervention in which participants engaged, including aspects of the intervention messaging that require clarification or
that may lead to unintended consequences (e.g., negative behavioral or psychological reactions). All relevant
intervention materials, including a sample RiskProfile, the standardized verbal script, and procedural manual, will be

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reviewed by design participants for their relevance and fit within the community setting. Additionally, participants will be
presented a de-identified recording of the RiskProfile being delivered to gather their feedback on the process. Finally,
focus group participants will be presented an experimental version of the RiskProfile “PrecisionTx” for feedback. This
version provides a hypothetical specific recommendation of medication based on genetic/metabolic factors. We will seek
feedback on the concept of including specific recommendations of medication as part of the genetically-informed tool.
The attached “GENIMP Aim 2_Focus Group Guide” will be used as a guide for the focus groups.
Focus groups will be conducted using elements of design thinking (e.g., human-centered design) which emphasizes (1)
developing empathy for target end-users (i.e., current smokers not yet ready to quit), (2) radical collaboration with input
from a diverse set of perspectives, and (3) rapid prototyping by iteratively generating and vetting ideas of refinements
to the tool in collaboration with participants (i.e., both current smokers and substance abuse counselors). Although the
primary mode of delivery to be explored will be in-person sessions with substance abuse counselors, we will also explore
the potential feasibility of more scalable intervention delivery platforms, including postal mail and web-based tools to
deliver the intervention content. We will also examine perceptions of communication framing strategies among current
smokers with relatively high and low genetic risks for smoking-related diseases.
A second group of current smokers (n=25) and counselors and peer support specialists (n=10) will be engaged in a
small-scale feasibility trial of the genetic testing and intervention delivery protocol. Using the same study procedures in
Aim 1 to guide participants to create a 23andMe account and provide their saliva sample via genetic testing, the second
group of current smokers will undergo genetic testing while they are inpatient at Wellbridge and then be invited to
receive their RiskProfile at the next counseling session via Zoom or in-person at Wellbridge, which will be delivered by a
counselor or peer support specialist at Wellbridge, once their genetic data is ready.
Using structured assessments (attached for approval), we will assess the acceptability and feasibility of the RiskProfile
using quantitative and qualitative metrics for both patients and clinicians. We will use modified versions of the Aim 1
assessments, the Acceptability of Intervention Measure (AIM), and the Feasibility of Intervention Measure (FIM). The
AIM (4 items measuring approval, appeal, and favorability of the RiskProfile) and FIM (4 items measuring usability,
intuitiveness, and comprehensibility) is measured on a 5- point scale (Completely disagree=1.0; Completely agree=5.0).
1.14
Will participants be randomized?
Yes
1.15
Will any of the following be used to collect information from the participant or others?
Screening questions or screening/eligibility questionnaires
Surveys
Questionnaires
Stimuli
Any other written assessments
Yes
Attachment Name
Category
Version
Date Attached
Aim 2_V1
Assessment_07142023.docx
Subject Data Collection
Instruments
1
07/14/23
Aim 2_Clinician V2
Assessment.docx
Subject Data Collection
Instruments
1
07/14/23
Eligibility Screener for Focus
Groups.docx
Subject Data Collection
Instruments
1
10/07/22
V5 Assessment_7-10-23.docx
Subject Data Collection
Instruments
4
07/11/23
V1 Assessments_08052021.docx
Subject Data Collection
Instruments
15
08/05/21
Aim 2_V2
Assessment_071423.docx
Subject Data Collection
Instruments
1
07/14/23
Open Ended Interview
Questions_082620.docx
Subject Data Collection
Instruments
7
08/28/20
Eligibility Script for
GENIMP2_011421 (1).docx
Subject Data Collection
Instruments
4
01/14/21
V4 Assessments_7-10-2023.docx
Subject Data Collection
Instruments
12
07/11/23
Locator Form.docx
Subject Data Collection
Instruments
1
06/25/19
Script for Report Card Design
Feedback_071919.docx
Subject Data Collection
Instruments
5
07/22/19
GENIMP Aim 2_Focus Group
Guide Final.docx
Subject Data Collection
Instruments
1
10/07/22
V2 Assessments_7-10-23.docx
Subject Data Collection
Instruments
17
07/11/23
V3 Assessments_7-10-23.docx
Subject Data Collection
Instruments
17
07/11/23
1.16
Does this project involve creating any audio, video, or photographs?
Yes

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1.17
Does the study include any form of deception (e.g., providing participants with false information, misleading information,
or withholding information about certain study procedures)?
Examples:
Procedure includes a cover story that provides a plausible but inaccurate account of the purposes of the research.
Participants will be provided with false information regarding the particular behaviors of interest in the research.
Procedures include a confederate pretending to be another participant in the study.
Participants will be told that the research includes completion of a particular task, when in fact, that task will not be
administered.
Study is designed to introduce a new procedure (or task) that participants are not initially told about.
No
1.18
Indicate any payments or reimbursements to participants (check all that apply)
Cash
Check
Gift or Debit Card
Forte Debit Card
1.19
Does this study have a plan to have an individual or committee review combined data from all participants on a periodic
basis (such as summary or aggregate safety and/or efficacy data)?
No
1.20
What have you done to minimize any risks?
•  No forseeable risks
1.21
What are the potential benefits related to this project for:
the participant (if any)
benefits to society (if any)
Participants (adults who smoke) will have the direct benefit of receiving their individual genomic results profiles
which could potentially improve their health behaviors (e.g., reduce tobacco use) and effectiveness of their
treatment plans. Participants will receive genetic testing by 23andMe at no cost to them. From 23andMe they will
receive genetic ancestry results and health results including carrier status reports, trait reports, and wellness
reports.
The potential benefits to society are significant if the proposed research increases understanding of the best
approaches to integrating genomic findings for substance use disorders into diverse settings. It is possible that the
results of this study could be used to improve smoking and substance use disorder prevention and treatment
strategies.
1.22
Provide a summary of the analysis methods you will use, including, if applicable, the data points or outcomes you
will analyze.
For Aim 1, we will assess the acceptability of using genomic results (i.e., % agreeing to genetic testing, sharing
results with others, recalling personal genomic results) and test whether smoking behaviors (frequency, heaviness)
change more following delivery of the RiskProfile intervention than following brief cessation counseling. We expect
higher rates of smoking cessation and reduction the Intervention group, particularly for those who accepted and
recall their genomic results and whose health-related cognitions were altered (e.g., increased perceptions of disease
risk, cessation benefits, value of cessation medications, self-efficacy). We will also examine whether the acceptability
and recall of their genomic data for smoking cessation differ by age, sex, race, education level, or initial smoking
behaviors. Given prior research on disparities in use of genomic results, we anticipate that acceptability and recall of
results, or other mechanisms of behavior change, may be lower in African Americans, men, and heavier smokers. We
will conduct multiple linear regression analyses to determine the extent to which race, initial smoking heaviness, or
level of genetic risk predict acceptability and recall of genomic results, and whether receiving the RiskProfile predicts
smoking cessation or reduction.
For Aim 2, we will identify key themes that will guide the adaption and improvement of the RiskProfile to deliver the
tool in real-world settings. Adapting the RiskProfile will include data points consisting of refining the content, format,
and delivery mode.
1.23
Provide the rationale or power analysis to support the number of participants proposed to complete this study.
Prior samples of a similar size and nature have allowed for adequate generalizability and power to detect
relationships between variables of interest, including the ability to detect moderating relationships through
interaction analyses. The current study is expected to mirror this prior experience, yielding adequate validity and
range of responses. However, this study stands on its own as a pilot project, and any challenges related to power
analysis do not negate the usefulness of this small-scale project to demonstrate proof of concept, establish the
feasibility of returning genomic results to patients and physicians in a clinical setting, and provide the necessary
rationale to test these implementation approaches with larger samples in future research.
1.25
Will any data from this project be stored for use in future research studies?
Yes - contribution for future use is optional
1.26
Does this project involve the collection or use of biological samples or genetic data?

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Yes
1.26.a
Will genetic/genomic research occur as part of this study?
Yes
1.26.b
Do you plan to return any genetic/genomic results of testing generated as part of this study to participants
(including either primary or incidental findings)?
Yes
1.26.c
Attach a return of results plan.
Attachment Name
Category
Version
Date Attached
Return of Results
Plan_082620.docx
Return of Results Plan
7
08/28/20
1.26.d
Will biologic samples or genetic data be stored for future research?
No
1.26.f
Will participants be able to request at a later time that the biological samples or genetic data be destroyed?
No
1.27
Are you requesting institutional certification to contribute human data or samples to a repository or database for broad
sharing (public or restricted access)?
No
2. Participants
2.1
Will there be any adult participants?
Yes
2.1.a
How many adult participants do you expect to consent or enroll under a waiver for this project?
600
2.1.b
What is the age of the youngest adult participant?
18.0
2.1.c
What is the age of the oldest adult participant?
No age limit
2.2
Will there be any minor participants?
No
2.3
Will there be any emancipated minor participants?
No
2.7
Do you plan to recruit/enroll non-English speaking people?
No
2.8
Do you propose to enroll any of the following in this study as participants?
Employee of the PI or employee of a research team member
Individual supervised by PI or supervised by member of research team
Individual subordinate to the PI or subordinate to any member of the research team
Student or trainee under the direction of the PI or under the direction of a member of the research team
No
2.9
Is this project about pregnant women?
No
2.10
Will this project involve fetuses?
No
2.11
Does this project involve the use of fetal tissue from any source?
No
2.12
Does this project recruit adult participants who may be incompetent or have limited decision-making capacity on initial
enrollment into the study?
No
2.13
Does this project involve prisoners as participants?
No

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3. Performance Sites
3.1
Indicate type of site(s) where research will occur (check all that apply):
•  Hospital
•  Academic Institution
3.2
Where will project procedures take place (check all that apply)?
School of Medicine
Danforth Campus
Barnes Jewish Hospital (BJH)
Barnes Jewish West County
Barnes Jewish St. Peters
Boone Hospital Center
Christian Hospital NE
Goldfarb School of Nursing
St. Louis Children's Hospital
U.S. off-campus - Meetings with National Council on Alcoholism and Drug Abuse – St. Louis Area (NCADA) staff to
get feedback on the report card template may take place at the NCADA office off-campus, for convenience of study
participants. Focus groups will take place at Wellbridge Addiction Treatment and Research to get feedback on the
RiskProfile (letter of support attached).
3.3
Is this project also being conducted by other researchers at their own sites (e.g. a multi-site collaborative project)?
No
4. Drugs/Devices
4.1
Does this project involve:
Yes No  
Drug(s) (including radioisotopes)
Use of contrast agent(s)
Other substance injected, ingested, or applied to the body
Testing a Device (Including companion devices, software, mobile health devices, assays, not FDA approved or
outside approved indications, etc.)
Combination product (as determined by the FDA - must have FDA documentation identifying this as a
combination product)
4.2
Does this project involve a drug washout (asking participant to stop taking any drugs the participant is currently taking)?
No
4.3
Will any participants receive a placebo in place of standard therapy?
No
5. Privacy & Confidentiality
5.1
Indicate your plans to protect the privacy interests of the participants during the conduct of the study (check all that
apply):
•  Only the minimum necessary private information is collected for the purposes of the study
•  Any procedures or interventions conducted as part of the study will be conducted in private setting to the extent
possible
•  Recruitment/consent will occur in a private setting
•  Participants will be able to ask questions in a private setting
5.2
Are you collecting or using the Social Security Number of any participants for any purpose?
Yes
5.2.a
Provide the intended usage of SSN:
To provide compensation to participants
5.3
Project uses paper or hard copy consents, surveys, data collection forms, research subject binders, or other hard copy
materials (check all that apply):
Yes
•  All materials are stored in secured environment
•  Access is limited to research team members only

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5.4
Project collects, stores and/or transmits electronic data on mobile devices, desktop computers, servers including cloud
servers, email, or any other information in electronic form (check all that apply):
Yes
•  Data are encrypted
•  Data in Redcap
•  Data in Survey Monkey
•  Data in Qualtrics (Use of Qualtrics is not allowed when collecting Protected Health Information (PHI) or Personally
Identifiable Information (PII) (Information Security Requirements).
•  Password protected
•  Access is limited to research team only
5.5
Project collects or uses biologic specimens (check all that apply):
Yes
•  Transported securely/shipped with tracking mechanism
•  Stored in secured environment
•  Coded and the identifiers or key is stored separately from the data
5.6
Identify any additional protections in place for data and or samples (check all that apply):
•  Formal research staff training process