Clinical trial NCT03309943
Conditions: Cigarette Smoking
Sponsor: Duke University
Start date: 2018-01-16; Completion date: 2019-07-15
Enrollment: 44 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The central objective of this project is to obtain proof-of-concept data demonstrating the effects of propranolol (a beta-adrenergic antagonist) on neurobiological responses to personal smoking environments and behavioral responses in a laboratory smoking behavior task. Human cigarette smokers (N = 50) will take photographs of locations where they do and do not smoke cigarettes. They will then be randomly assigned to receive either propranolol (40 mg) or placebo prior to completing: A) An MRI session assessing neural responses to personal smoking/non-smoking environments, standard smoking/non-smoking environments and proximal smoking/non-smoking cues; and B) A laboratory session examining smoking behavior in response to environmental cues.

Detailed description:

Arms: arm 1: Propranolol Capsule: 40 mg IR, administered 2x at separate laboratory sessions arm 2: Placebo Capsule: No active ingredients, administered 2x at separate laboratory sessions
Interventions: intervention 1: Propranolol intervention 2: Placebo
Intervention descriptions: intervention 1: Participants will take one dose of Propranolol (40mg IR) on two separate occasions. intervention 2: Participants will take one dose of Placebo on two separate occasions.

Protocol documents:
Prot_SAP_001.pdf: 
Project Title: Neurobehavioral Substrates of Propranolol’s Effects on Drug Cue Reactivity 
NCT #: NCT03309943 
Document Date: 11/11/2019 
 
 


We propose to obtain consent from a total of 75 smokers in order to identify 40 who meet all inclusion and 
exclusion criteria and provide usable data sets. Participants will complete an initial screening either online or 
over the phone. In both cases, the study will be described in detail and preliminary participant characteristics 
will be assessed (e.g. age, number of cigarettes per day, use of exclusionary medications or medical conditions 
that would preclude participation). Online screenings will be administered via Duke REDCap questionnaires. 
Participants who complete the online screen will also be contacted by phone to confirm information and provide 
additional study information. Those participants who appear to meet criteria for participation will be invited to 
our offices for an informed consent and screening visit. Identifying information from the phone screen for 
participants who do not meet inclusion criteria will be kept until recruitment for this study is completed and 
stored on a secure department server. See Waiver of Consent and HIPAA authorization. Participants or potential 
participants will be provided with a copy of the drug insert upon request - either by email/postal mail in advance 
of participation or at their screening visit.  
  
Screening Session 
Volunteers who meet initial eligibility criteria (determined by online/phone screening) will be asked to attend 
an in-person screening approximately 2-3 hours in length. The PI or other study staff will give a ~10 minute 
presentation describing details of the study procedures and risks. They will be provided with a consent 
document to review and given the opportunity to ask questions. They will then obtain informed consent. 
Afterwards, participants will: 
  
• 
Provide breath samples for expired breath carbon monoxide (CO) level analysis using a CO meter. This 
is a reliable and valid measure of recent smoking. 
• 
Provide a breath sample for analysis of breath alcohol level using an AlcoSensor breathalyzer device. 
Participants with levels > .000 will be offered one opportunity to reschedule their visit – any further 
positive readings will result in exclusion. 
• 
Urine samples will be obtained to screen for pregnancy (HCG) among female participants and illicit 
drug use among all participants. 
• 
Established questionnaires will be used to assess nicotine dependence (Fagerstr m Test for Nicotine 
Dependence) and quit motivation (Contemplation ladder). A detailed smoking history will also be 
obtained. 
• 
Additional questionnaires will be used to assess other potential moderators and variables of interest for 
exploratory analysis 
• 
The MINI International Neuropsychiatric Interview will be conducted by the PI or other staff working 
under his supervision in order to screen for exclusionary psychopathology. 
• 
Participants will undergo a full physical exam conducted by the study physician (Dr. Rachel Dew) to 
ensure safety of propranolol administration. This will include blood pressure readings and EKG. A 
blood sample will be drawn and submitted for analysis (CBC, basic metabolic panel and serum 
pregnancy [females]) and reviewed once available (prior to drug administration). Depending on 
scheduling and physician/psychologist availability, participants will also have the option of completing 
the physical exam and clinical interview at the training visit or camera return visit. These will always 
occur prior to randomization/drug administration. 
• 
Complete a visual acuity exam 
  
Certain components of the procedure (e.g. MINI, cognitive tests) may be audio recorded. Failure to meet 
requirements for the study will result in dismissal. Sexually active females must agree to use contraception 
during the course of the study and notify study staff if they become pregnant during the course of the study. Per 
standard procedures at the Brain Imaging and Analysis Center, an additional pregnancy test will occur at these 
sessions. 
 
  


Training Session 
Participants who did not complete a medical exam at the baseline visit will do so at this visit. In addition, they 
will be exposed to a “mock” MRI scanner and asked to complete an abbreviated picture viewing task so that 
they can experience the scanner environment and ensure they are comfortable completing MRI sessions. 
Eligible participants will be trained in the picture-taking procedures, provided a camera if they do not own a 
suitable one and scheduled to return in approximately one week. They will be asked to take > 5 photographs of 
smoking and non-smoking environments as identified during interviews. 
  
  
Camera Return Session 
Participants will return the camera they were provided. Images will be downloaded and reviewed for 
appropriateness. If necessary, they will be given additional time to obtain appropriate images. If images are 
deemed appropriate, the participant will be scheduled for an MRI session. In addition, participants will 
complete a brief “Environment Go-NoGo task.” This is a modified version of the standard Go-NoGo task. 
Stimuli (letters, numbers or symbols) will be embedded in images consisting of smoking (e.g. bus stop) or non-
smoking (e.g. church) environments. Participants will view blocks of these stimuli be instructed to identify a the 
presence of a particular stimulus by button press. . 
  
fMRI Session 
Participants will be required to be 24 hours abstinent at the time of the scan as indicated by a breath CO level < 
8 ppm. Participants will also be tested for breath alcohol and must record a BrAC of < 0.001. Participants who 
do not meet the CO level may be provided one opportunity to reschedule at the discretion of the PI or study 
staff. Participants who are unable to attain the required CO level will be withdrawn. Participants will be 
instructed to eat 1 hour prior to their appointment in an effort to standardize drug absorption. Research staff will 
meet participants at the scanning facility. Drug will be stored in a secure closet in our laboratory and walked 
over to the hospital for administration during the scanning session. CO will be collected upon participant 
arrival. Afterwards, participants will be randomly assigned to propranolol (40 mg) or placebo conditions. These 
will be administered 1.5 hours prior to scanning. Heart rate and BP will be monitored every 45 minutes during 
the intervening period. Self-report assessments of craving (Questionnaire on Smoking Urges – Brief) and 
nicotine withdrawal (Minnesota Nicotine Withdrawal Scale), among other measures, will be obtained 
immediately prior to drug administration and again immediately prior to scanning. During the scan, participants 
will be positioned in a 3T MRI scanner and completing a resting scan, anatomical scan and several function 
runs during which they will view images of the environments they photographed, as well as standard 
smoking/non-smoking environments and proximal smoking/neutral cues. Heart rate and respiration will be 
monitored during resting tasks. Respiration will be monitored during all tasks. 
  
Laboratory Session 
Participants will attend a final laboratory session. They will be required to be 6 hours abstinent at the time of the 
session as indicated by a 40% reduction in breath CO from the value obtained at the screening session. 
Participants will also be tested for breath alcohol and must record a BrAC of < 0.001. As above, participants 
who do not meet the CO level may be provided one opportunity to reschedule at the discretion of the PI or study 
staff. Participants who are unable to attain the required CO level will be withdrawn. Next, they will repeat the 
previously administered craving/withdrawal measures. As with the MRI session, participants will be instructed 
to eat 1 hour prior to their appointment in an effort to standardize drug absorption. A second dose of propranolol 
or placebo will be administered 1.5 hours before the cue exposure task. As above, heart rate and BP will be 
monitored during the intervening period and self-report assessments of craving and withdrawal will be obtained 
immediately prior to beginning the task. The task will consist of an initial 2-minute cue exposure period, 
followed by an additional craving assessment. Next, participants will view cues for an additional 12 minutes 
during which they will have ad libitum access to their cigarettes and are informed they may smoke freely. 
Participant behavior will be video recorded during this period for later coding by video. After the ad 
lib smoking period, participants will complete an additional set of measures, as well as an additional CO 
assessment. At the conclusion of this session, participants will meet with the PI or staff working under his 


supervision. They will be provided with the smoking behavior report, psychoeducation about smoking behavior 
and the importance of cessation, and a list of referrals. In addition, they will be provided with a stack of study 
recruitment materials and encouraged to distribute them to family and friends who smoke as typical of a 
snowball sampling approach. However, per Duke IRB policy, no incentives will be offered for distributing these 
materials.  
 
Statistical Analysis Plan 
Analyses will examine the effects of propranolol: (1) BOLD activation and connectivity in response to smoking cues; (2) 
Smoking urge in response to smoking cues during the MRI task; (3) Smoking urge in response to personal smoking 
environment cues during the laboratory task; and (4) Smoking behavior during the laboratory smoking task. 
Primarily analyses of BOLD activation results will utilize and ROI-based approach. Percent signal change in response to 
all cue types will be extracted from the hippocampus (both posterior and anterior), amygdala, medial prefrontal cortex and 
anterior insula. Extracted values will then be examined using SPSS mixed models, utilizing repeated statements in lieu of 
random effects (analogous to repeated measures ANOVA). A compound symmetry covariance structure will be specified. 
Analyses will examine the effects of drug condition on cue reactivity. For BOLD Activation, our primary outcome will be 
the overall smoking cue reactivity effects (i.e. collapsing across image type – proximal, standard environment, personal 
environment) although planned contrasts will break these down by individual image types to clarify effects. In addition, 
we will use a psychophysiological interaction approach to extract indices of brain connectivity while viewing smoking-
related images. We anticipate using a hippocampus seed based on pre-clinical findings, but a final determination will be 
based on the pattern of activation observed in the present study. Any baseline group differences will be adjusted for in 
these analyses. Connectivity between the seed region and other relevant brain regions (same as above) will also be 
examined. An identical approach will be used to examining smoking urge during the MRI task. 
Smoking urge and behavioral outcomes for the laboratory task will be analyzed using similar procedures. First, video data 
will be coded by two independent raters. Substantive disagreements will be resolved through discussion, the average value 
will be taken when minor disparities are present. For self-reported urge, analyses will examine drug effects on post-cue-
presentation urge ratings (again, adjusting for any baseline group differences, as well as pre-cue-presentation urge rating). 
Analysis of behavioral outcomes will follow a similar approach – although a variety of indices of smoking behavior will 
be computed our primary focus will be on the total number of puffs taken across the ad lib smoking period (aggregated 
across cigarettes when relevant).   

ICF_000.pdf: 
Project Title: Neurobehavioral Substrates of Propranolol’s Effects on Drug Cue Reactivity 
NCT #: NCT03309943 
Document Date: 4/30/2019 


Consent to Participate in a Research Study
Neurobehavioral substrates of propranolol’s effects on drug reactivity
Page 1 of 11
Subject Initials
DUKE UNIVERSITY HEALTH SYSTEM
Form
M0345
You are being asked to take part in a research study in the Department of Psychiatry, Duke University 
Medical Center (DUMC), on the neural and behavioral effects of propranolol in adult smokers. Research 
studies are voluntary and include only people who choose to take part. Please read this consent form 
carefully and take your time making your decision. As your study doctor or study staff discusses this 
consent form with you, please ask him/her to explain any words or information that you do not clearly 
understand. We encourage you to talk with your family and friends before you decide to take part in this 
research study. The nature of the study, risks, inconveniences, discomforts, and other important 
information about the study are listed below.
Please tell the study doctor or study staff if you are taking part in another research study.
A grant from the National Institute on Drug Abuse (NIDA) is sponsoring this study. Portions of Dr. 
Jason Oliver’s research team salaries will be paid by this grant.
WHO WILL BE MY DOCTOR ON THIS STUDY?
If you decide to participate, Dr. Jason Oliver will be your doctor for the study and will be in contact with 
your regular health care provider throughout the time that you are in the study and afterwards, if needed. 
Dr. Rachel Dew, MD, a member of the study team, will serve as medical monitor for the study.
CONCISE SUMMARY
This is a research study to determine the potential effects of propranolol, a common blood pressure 
medication, on smoking behavior. Participants will complete five visits that vary in length from 1 to 
3 hours over a period of about one month. The first visit is a screening visit and involves 
questionnaires, interviews and laboratory. At the second visit, you will practice some study tasks 
and be trained to take pictures of places you visit with a study camera. You will return the camera 
and complete some additional forms and tasks at the third visit. A medical exam will be conducted 
at one of these first three visits. If you complete them successfully, you will be scheduled for an 
MRI visit. You will be asked to abstain from smoking for 24 hours, given a single dose of 
propranolol and receive an MRI scan during which you will view and rate different pictures while 
we measure brain activity. At your last visit, you will take another dose of propranolol and complete 
a computer task during which you will have the opportunity to smoke cigarettes.
Risks for the study include the experience of nicotine withdrawal, bruising, fainting or excess 
bleeding from the blood draw, injury from the MRI if safety precautions are not followed, 
discomfort from answering certain questions, potential for loss of confidentiality and side effects of 
propranolol. A more detailed description is provided in this document. 
If you are interested in learning more about this study, please continue reading below.
DUHS IRB
IRB NUMBER: Pro00083809
IRB REFERENCE DATE: 04/30/2019
IRB EXPIRATION DATE: 05/17/2020


Consent to Participate in a Research Study
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WHY IS THIS STUDY BEING DONE?
The purpose of this study is to investigate the effects of propranolol on adult smokers. Propranolol is 
approved by the Food and Drug Administration and is a commonly prescribed beta-blocker medicine 
used to treat heart or circulatory conditions, such as high blood pressure and arrhythmia. Propranolol is 
not approved for use to help people quit smoking. In this study, this medication is being investigated to 
examine potential effects on smoking behavior. You are being asked to be in this study because you are 
an adult right-handed smoker who has no plans to quit smoking during the course of this study. The 
drugs that you will be given include propranolol and/or a placebo (a capsule that contains no active 
drug). We will measure your brain activity while you are in a MRI machine after you have taken these 
drugs. You will return back to the office on a separate day and complete some additional tasks after 
taking another dose of the medication.  
HOW MANY PEOPLE WILL TAKE PART IN THIS STUDY?
Approximately 75 people between the ages of 18 and 55 will be recruited for this study at Duke 
University Medical Center. 
WHAT IS INVOLVED IN THE STUDY?
If you agree to be in this study, you will be asked to sign and date this consent form prior to any tests or 
procedures. Then, you will have the following tests and procedures to make sure that you are eligible. 
The first visit will last around 2.5-3 hours. 

General Information: We will need to know your name, age, date of birth, sex, race, address, 
medical history, phone number, and social security number. We will need your social security 
number to process your participant payment. If you choose not to provide your social security 
number, we will not be able to reimburse you for your participation.

Urine Sample Collection: The urine sample will be used to test for drugs of abuse. Some 
prescription drugs can also be detected by this urine drug screen. If you test positive for any of 
the drugs measured by the drug screen, you will not be allowed to participate in this study. 

Expired Breath Collection: Breath samples will be used to measure the CO (carbon monoxide) 
and alcohol in your exhaled breath.

Medical History: You will provide information about your medical history.

Physical Exam: Participants will undergo a full physical exam by the study physician to ensure 
safety of propranolol administration. This will include blood pressure readings and EKG. A 
blood sample will be drawn and submitted for analysis. 

Nicotine Use History: You will provide detailed information about your current and past use 
nicotine. You will also identify places where you do smoke, as well as places where you do not 
smoke.

Psychiatric Screen: You will undergo a psychiatric evaluation for symptoms for psychiatric 
disorders 

MRI Safety Questionnaire: This questionnaire will help determine it if is safe for you to enter the 
MRI scanner.

Mock scanner: You will enter a mock MRI scanner to assess if you do feel comfortable in order 
to complete a real MRI session
DUHS IRB
IRB NUMBER: Pro00083809
IRB REFERENCE DATE: 04/30/2019
IRB EXPIRATION DATE: 05/17/2020


Consent to Participate in a Research Study
Neurobehavioral substrates of propranolol’s effects on drug reactivity
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The results of the screening tests and procedures will be reviewed by the study staff to determine if you 
continue to qualify for this study. Portions of these exams may occur at the 2nd or 3rd visit depending on 
staff and scheduling. Your responses during some of these tests may be audio recorded. If the results of 
your tests indicate that you cannot continue in the study, your participation in the study will end. If you 
continue to qualify and you feel comfortable in continuing to participate in the study, you will then 
begin the study.
In the next part of the study, you will fill out a series of questionnaires regarding your personality, and 
behavior, and then be trained on how to take pictures using the study camera. You will complete 
practice versions of tasks you will do later. be asked to take at least 5 photographs of smoking and non-
smoking environments as identified earlier. This visit will last around 1.5 hours. At the end of this 
session, you will be scheduled to return for a camera return session.
In the camera return session, we will view the images that you had taken and decid if they are 
appropriate for the study. You will also complete a short computer task. This visit will also last about 
1.5 hours. 
The next visit will be the MRI session. You will be asked to abstain from smoking for 24 hours before 
your scheduled fMRI. You will submit a breath sample to be tested for carbon monoxide to ensure that 
you have abstained. If you do exceed the allowed amount of carbon monoxide measure, you will not be 
allowed to complete the scan. Afterwards, you will be administered either propranolol or a placebo 
medication. A placebo is an inactive substance given in the same forma sat the active drug, propranolol. 
You will be randomly assigned (like the flip of a coin) to receive either propranolol or placebo. You 
have a 1 in 2 chance of receiving study drug.  For the next 1.5 hours, you fill out questionnaires and your 
blood pressure and heart rate will be monitored. During the scan, you will be viewing images that you 
had photographed, as well as other images. This visit will last about 3 hours. 
The final visit will back in our office that will require you to be abstinent from smoking for six hours 
before your appointment time. As with the last visit, you will be asked to submit a breath sample and if 
you exceed the allowed amount of carbon monoxide, you will not be allowed to complete the visit and 
may be withdrawn from the study. In this visit you will again be administered either propranolol or 
placebo, fill out questionnaires and complete another computer task. You will view pictures of smoking 
locations and will have the opportunity to smoke cigarettes. We will video tape your smoking behavior 
during this part of the session. At the end of this session, we will discuss how much money you have 
earned for the entire study. This last visit will last about 2.5 hours. 
HOW LONG WILL I BE IN THIS STUDY?
All subjects will have a total of 5 visits (1 screening visit, 1 training visit, 1 camera return session, a 
fMRI session, and laboratory session). This study can be completed within 2 – 4 weeks based on 
availability and schedule preferences. 
DUHS IRB
IRB NUMBER: Pro00083809
IRB REFERENCE DATE: 04/30/2019
IRB EXPIRATION DATE: 05/17/2020


Consent to Participate in a Research Study
Neurobehavioral substrates of propranolol’s effects on drug reactivity
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You can choose to stop participating at any time without penalty or loss of any benefits to which you are 
entitled. However, if you decide to stop participating in the study, we encourage you to talk to your 
doctor first.
WHAT ARE THE RISKS OF THE STUDY?
For Women of Childbearing Potential: 
Being a part of this study while pregnant may expose the unborn child to significant risks, some of 
which may be currently unforeseeable. Therefore, pregnant women will be excluded from the study. If 
you are a woman of childbearing potential, a blood pregnancy test will be done (using 2 teaspoons of 
blood drawn from a vein by needle-stick), and it must be negative before you can continue in this study. 
Urine pregnancy tests will also be conducted prior to receiving the study medications. These tests must 
be negative before you can continue in the study. If sexually active, you must agree to use appropriate 
contraceptive measures for the duration of the study. Medically acceptable contraceptives include: (1) 
surgical sterilization (such as a tubal ligation or hysterectomy), (2) approved hormonal contraceptives 
(such as birth control pills, patches, implants or injections), (3) barrier methods (such as a condom or 
diaphragm) used with a spermicide, or (4) an intrauterine device (IUD). Contraceptive measures such as 
Plan B (TM), sold for emergency use after unprotected sex, are not acceptable methods for routine use. 
If you do become pregnant during this study or if you have unprotected sex, you must inform your study 
physician immediately. 
Risks of Blood Drawing:
Risks associated with drawing blood from your arm include momentary discomfort and/or bruising.
Infection, excess bleeding, clotting or fainting are also possible, although unlikely. The total amount of 
blood drawn for the entire study will not exceed 4 teaspoons (20 ml).
Propranolol Side Effects:
The primary risk associated with this study are the side effects associated with the study medication. 
Common side effects include hypotension, bradycardia (slow heart rate), cold extremities, transient 
fatigue, sleep disturbance, drowsiness, agitation and irritability, dizziness, and Raynaud’s phenomenon 
(e.g. coldness/numbness in the fingers and toes). 
Most of the side effects are minor and resolve quickly on their own. In order to minimize risks, we do 
ask that you give your medical history and completely and accurately as possible. We will monitor these 
risks by closely monitoring you and your blood pressure and heart rate during experimental sessions. 
Effects of Nicotine Withdrawal:
You may experience the following symptoms when you abstain from smoking for the two periods (one 
for 24-hours and another for 6-hours) in the study: cravings for nicotine, anxiety, irritability, 
restlessness, mood changes, nervousness, disruptions of you sleep, drowsiness, trouble concentrating, 
increased appetite, headaches, muscular pain, constipation and fatigue. These may begin almost 
immediately after you stop smoking.  
DUHS IRB
IRB NUMBER: Pro00083809
IRB REFERENCE DATE: 04/30/2019
IRB EXPIRATION DATE: 05/17/2020


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Functional Magnetic Resonance Imagining (fMRI) Risks: 
Magnetic resonance imaging (MRI) uses a magnet and radio waves to make diagnostic medical images 
of the body. There have been no ill effects reported from exposure to the magnetism or radio waves used 
in this test. However, it is possible that harmful effects could be recognized in the future.
A known risk is that the magnet could attract certain kinds of metal. Therefore, we will carefully ask you 
about metal within your body (this includes certain dyes found in tattoos). If you have metal within your 
body, tell us immediately, since it will be dangerous for you to be in an MRI machine. If there is any 
question about potentially hazardous metal within your body, you will be excluded from participating in 
this research study. We will also keep the MRI locked so that no one carrying metal objects can enter 
while you are in the scanner.
The study involves entering a large room in which a magnet is present. You will be placed on a narrow 
bed and then slid into a small tunnel approximately 6 feet in length and 25 inches in diameter. You will 
be asked to lie still for about one hour on this bed and will hear loud noises during this time. Some 
people who are claustrophobic (afraid of being in cramped places like closets or crowded elevators) may 
experience extreme anxiety when placed in a MRI machine. You may be asked to have a harmless 
monitoring device applied during the study. During the study, you will have voice contact with the 
technician in between scans. 
There may be risks, discomforts, drug interactions or side effects that are not yet known. 
Psychiatric Assessment Risks:
This is a research study that involves questions that ask about your mental state which may cause discomfort. 
As researchers, we do not provide mental health services. It is possible that we will not view your responses 
for several days, weeks, or months after you complete the surveys. Therefore, we will not know of any 
immediate risks that you may have for harming yourself or others, including suicidality. Should you decide 
you need assistance at any time while enrolled in this study, please contact the study doctor (919-681-0031) 
or principal investigator (919-668-0093) for clinic referrals, or the National Suicide Prevention Lifeline (1-
800-273-8255).
Confidentiality:
The information obtained as a result of your participation in this research will not be included in your 
medical record by research staff. Information from which you may be personally identified will be 
maintained in a confidential, locked file at DUMC or on a secured department server accessible only to 
the study. Information will not be disclosed to third parties except with your permission or as may be 
required by law. There is a potential risk of loss of confidentiality. Every effort will be made to keep 
your information confidential; however, this cannot be guaranteed. Some of the questions we will ask 
you as part of this study may make you feel uncomfortable. You may refuse to answer any of the 
questions and you may take a break at any time during the study. You may stop your participation in this 
study at any time.
DUHS IRB
IRB NUMBER: Pro00083809
IRB REFERENCE DATE: 04/30/2019
IRB EXPIRATION DATE: 05/17/2020


Consent to Participate in a Research Study
Neurobehavioral substrates of propranolol’s effects on drug reactivity
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There may be risks, discomforts, drug interactions or side effects that are not yet known. Your risk of 
being harmed by participating in this study may increase if you do not give your health history as 
accurately and as completely as you can.
The Department of Health and Human Services (HHS) has issued a Certificate of Confidentiality to 
further protect your privacy.  With this Certificate, the investigators may not disclose research 
information that may identify you in any Federal, State, or local civil, criminal, administrative, 
legislative, or other proceedings, unless you have consented for this use. Research information protected 
by this Certificate cannot be disclosed to anyone else who is not connected with the research unless:  
1) there is a law that requires disclosure (such as to report child abuse or communicable 
diseases but not for legal proceedings); 
2) you have consented to the disclosure, including for your medical treatment; or 
3) the research information is used for other scientific research, as allowed by federal 
regulations protecting research subjects. 
Disclosure is required, however, for audit or program evaluation requested by the agency that is funding 
this project or for information that is required by the Food and Drug Administration (FDA).
 
You should understand that a Confidentiality Certificate does not prevent you or a member of your 
family from voluntarily releasing information about yourself or your involvement in this research. If you 
want your research information released to an insurer, medical care provider, or any other person not 
connected with the research, you must provide consent to allow the researchers to release it. This means 
that you and your family must also actively protect your own privacy.
Finally, you should understand that the investigator is not prevented from taking steps, including 
reporting to authorities, to prevent serious harm to yourself or others.
ARE THERE BENEFITS TO TAKING PART IN THE STUDY?
You will not benefit from being in this study, although the knowledge gained may benefit others.
WILL MY INFORMATION BE KEPT CONFIDENTIAL?
Participation in research involves some loss of privacy. We will do our best to make sure that 
information about you is kept confidential, but we cannot guarantee total confidentiality. Your personal 
information may be viewed by individuals involved in this research and may be seen by people 
including those collaborating, funding, and regulating the study. We will share only the minimum 
necessary information in order to conduct the research. Your personal information may also be given out 
if required by law. 
As part of the study, results of your study-related laboratory tests, x-rays, and procedures may be 
reported to NIDA and its affiliates. In addition, your records may be reviewed in order to meet federal or 
DUHS IRB
IRB NUMBER: Pro00083809
IRB REFERENCE DATE: 04/30/2019
IRB EXPIRATION DATE: 05/17/2020


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state regulations. Reviewers may include from the National Institutes of Health, the Duke University 
Health System Institutional Review Board, and others as appropriate. If any of these groups review your 
research record, they may also need to review your entire medical record.
The study results will be retained in your research record for at least six years after the study is 
completed. At that time either the research information not already in your medical record may be 
destroyed or information identifying you will be removed from such study results at DUHS.  Any 
research information in your medical record will be kept indefinitely.
This information may be further disclosed by the sponsor of this study.  If disclosed by the sponsor, the 
information is no longer covered by federal privacy regulations. If this information is disclosed to 
outside reviewers for audit purposes, it may be further disclosed by them and may not be covered by 
federal privacy regulations.
While the information and data resulting from this study may be presented at scientific meetings or 
published in a scientific journal, your name or other personal information will not be revealed.
Some people or groups who receive your health information might not have to follow the same privacy 
rules. Once your information is shared outside of DUHS, we cannot guarantee that it will remain private. 
If you decide to share private information with anyone not involved in the study, the federal law 
designed to protect your health information privacy may no longer apply to the information you have 
shared.  Other laws may or may not protect sharing of private health information.
All of the laboratory tests and questionnaires are being given only because you are in this study. The 
study results will not be given to you to send or be sent to your physician to include in your medical 
record. Any significant new findings found out during this research, which may change your willingness 
to continue to be in the research, will be given to you.
There are certain situations in which confidentiality may be broken. Possible legal exceptions to 
confidentiality may occur if necessary to protect yourself or others from abuse or neglect, or in cases of 
potential harm to oneself or others. In such cases, confidentiality would only be broken in order to 
protect you or others from significant harm or death.
WHAT ARE THE COSTS?
There will be no additional costs to you as a result of being in this study. We do provide hospital parking 
passes if you choose to drive to your MRI session. Visitor parking is free at our office. 
WHAT ABOUT COMPENSATION?
You will be compensated $20 for the screening visit, provided you test negative for drugs and alcohol 
and testing confirms you are a smoker. If you are eligible and complete this study, you will earn $25 for 
the training visit and $25 for the camera return session, $150 for the fMRI session, and $150 for the 
laboratory session. You can earn an additional $50 for completing the entire study. Therefore, the total 
DUHS IRB
IRB NUMBER: Pro00083809
IRB REFERENCE DATE: 04/30/2019
IRB EXPIRATION DATE: 05/17/2020


Consent to Participate in a Research Study
Neurobehavioral substrates of propranolol’s effects on drug reactivity
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DUKE UNIVERSITY HEALTH SYSTEM
Form
M0345
maximum compensation for this study is $420. In order to be compensated, you do need to provide your 
social security number. You can participate in this study without giving a social security but you will not 
be compensated for your time. In addition to financial compensation, you will be able to receive an 
electronic or paper copy of an image of your brain derived from the MRI scan (for entertainment 
purposes only), assuming a sufficient quality image is obtained. In addition, at your final session you 
will receive a report based on some of the information we learned about you during your participation.
WHAT ABOUT RESEARCH RELATED INJURIES?
Immediate necessary medical care is available at Duke University Medical Center in the event that you 
are injured as a result of your participation in this research study. However, there is no commitment by 
Duke University, Duke University Health System, Inc., or your Duke physicians to provide monetary 
compensation or free medical care to you in the event of a study-related injury. For questions about the 
study, contact Dr. Jason Oliver at 919-668-0093 during regular business hours. For a research-related 
injury, contact Dr. Rachel Dew at 919-681-0031 during regular business hours and at 919-970-8541 
after hours and on weekends and holidays.
WHAT ABOUT MY RIGHTS TO DECLINE PARTICIPATION OR WITHDRAW FROM THE 
STUDY?
You may choose not to be in the study, or, if you agree to be in the study, you may withdraw from the 
study at any time. If you withdraw from the study, no new data about you will be collected for study 
purposes unless the data concern an adverse event (a bad effect) related to the study.  If such an adverse 
event occurs, we may need to review your entire medical record.
Your decision not to participate or to withdraw from the study will not involve any penalty or loss of 
benefits to which you are entitled, and will not affect your access to health care at Duke. If you do 
decide to withdraw, we ask that you contact Dr. Oliver in writing and let him know that you are 
withdrawing from the study. His mailing address is 2608 Erwin Rd, Suite 300, Durham, NC 27705.
Nonparticipation or withdrawal from this study will not affect your job status if you are a Duke 
employee and will not affect your grades if you are a Duke student.
We will tell you about new information that may affect your health, welfare, or willingness to stay in 
this study.
 
INCIDENTAL FINDINGS:
Although we will not be testing for any disorders or genetic diseases, it is possible that this study will 
identify information about you that was previously unknown, such as disease status or risk. There are no 
plans to provide this information to you or your physician unless the information indicates that you may 
be at risk for a disease known at the time of testing to potentially cause premature death if untreated, 
including suicidality. In that case, we will attempt to notify you using the contact information you have 
provided, so that you can speak with Dr. Oliver at Duke University Health System (DUHS). DUHS staff 
will not provide this information in a voice mail, email, or otherwise prior to contacting you. Please 
DUHS IRB
IRB NUMBER: Pro00083809
IRB REFERENCE DATE: 04/30/2019
IRB EXPIRATION DATE: 05/17/2020


Consent to Participate in a Research Study
Neurobehavioral substrates of propranolol’s effects on drug reactivity
Page 9 of 11
Subject Initials
DUKE UNIVERSITY HEALTH SYSTEM
Form
M0345
notify us of any change in your contact information. If you do not want to be notified of any incidental 
findings, please place your initials below. 
_____ (initials) Please do not notify me of any incidental findings obtained from this research. 
If you prefer, we can ask you at the time of notification whether or not you want to receive incidental 
findings information. In this case, please place your initials below. 
_____ (initials) Please ask me at the time of notification whether or not I want to receive incidental 
findings information.
It is possible that MRI scan will identify information about you that was previously unknown. Such 
incidental findings, if any, will not be shared with you unless the incidental finding is determined to be 
likely to cause premature death if untreated. Should such life-threatening results be uncovered, the 
principal investigator of the study will be informed. The information will be shared with you as follows: 
you will be notified via certified mail to contact Jason Oliver, PhD at Duke University Medical Center 
(DUMC). Notification will be sent to the address you provided to us. The DUMC staff will not release 
these specific research findings over the telephone or in the mail. Dr. Oliver will arrange for you to meet 
with him and/or other appropriate health care providers either at DUMC or another medical institution 
near your residence to review the research information.
WHOM DO I CALL IF I HAVE QUESTIONS OR PROBLEMS?
For questions about the study, contact Dr. Oliver at 919-668-0093 during regular business. For a 
research-related injury, or if you have problems, concerns, questions or suggestions about the research, 
contact Dr. Rachel Dew at 919-681-0031 during regular business hours and at 919-970-8541 after hours 
and on weekends and holidays.
For questions about your rights as a research participant, or to discuss problems, concerns or suggestions 
related to the research, or to obtain information or offer input about the research, contact the Duke 
University Health System Institutional Review Board (IRB) Office at (919) 668-5111.
DUHS IRB
IRB NUMBER: Pro00083809
IRB REFERENCE DATE: 04/30/2019
IRB EXPIRATION DATE: 05/17/2020


Consent to Participate in a Research Study
Neurobehavioral substrates of propranolol’s effects on drug reactivity
Page 10 of 11
Subject Initials
DUKE UNIVERSITY HEALTH SYSTEM
Form
M0345
STATEMENT OF CONSENT
"The purpose of this study, procedures to be followed, risks and benefits have been explained to me. I 
have been allowed to ask questions, and my questions have been answered to my satisfaction. I have 
been told whom to contact if I have questions, to discuss problems, concerns, or suggestions related to 
the research, or to obtain information or offer input about the research. I have read this consent form and 
agree to be in this study, with the understanding that I may withdraw at any time. I have been told that I 
will be given a signed and dated copy of this consent form."
__________________________________________
___________ ___________
Signature of Subject
Date
Time
__________________________________________
___________ ___________
Signature of Person Obtaining Consent
Date
Time
This space left intentionally blank.
DUHS IRB
IRB NUMBER: Pro00083809
IRB REFERENCE DATE: 04/30/2019
IRB EXPIRATION DATE: 05/17/2020


Consent to Participate in a Research Study
Neurobehavioral substrates of propranolol’s effects on drug reactivity
Page 11 of 11
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FUTURE RESEARCH
Dr. Oliver and his colleagues are often interested in follow-up or related studies. These may involve a 
return visit to the laboratory to complete similar questionnaires and tasks, or there may be a new study 
for which you might qualify to participate. If you are interested in possible future participation in such 
studies, we would keep your name on file and contact you about them in the future. The sole purpose of 
this initial contact would be to determine if you are interested in participating in a future study. There is 
no obligation to participate and your refusal for future contact will in no way affect your participation in 
the present study.
Please indicate whether or not you agree to be contacted in the future about participation in any follow-
up or related research studies by initialing one of the blanks below: 
____ I WOULD LIKE TO BE CONTACTED in the future to be provided more information about 
participation in follow-up or related research studies. 
____ DO NOT CONTACT ME in the future to provide more information about participation in 
follow-up or related research studies. 
Preferred method of contact (check 1 or more):
 Telephone # ( ) __________
 Mail (address) _____________________________
 E-mail (address) _________________@____________________________
__________________________________________ 
___________ 
___________
Signature of Subject 
Printed Name 
Date 
Time
__________________________________________
___________ 
___________
Signature of Person Obtaining Consent 
Date 
Time
DUHS IRB
IRB NUMBER: Pro00083809
IRB REFERENCE DATE: 04/30/2019
IRB EXPIRATION DATE: 05/17/2020