[Glossary]{.underline}

A

**Allergic Reactions:** Side effects from using lidocaine/prilocaine
(EMLA) generally have been mild and limited to short-term paleness or
redness of the skin. You should not scratch or rub your skin nor put hot
or cold objects on it while the area is still numb because you could
damage your skin when you can\'t feel pain.

**Allergic reactions to injecting Lidocaine:** Generally, injecting
lidocaine has not caused any problems. There may be a slight reaction,
such as a small rash, or swelling, and your skin may itch.

B

**Banking:** (One or more of the following should be used)

1\) Brookhaven National Laboratory would like to keep any extra
(data/blood/tissue) that is left over from this study for future
research. If you agree to this, the (data/blood/tissue) will be kept in
a (data/blood/tissue) bank and may be used later to learn more about
(e.g., HIV, drug/alcohol addiction, and personality). Your
(data/blood/tissue) will be used in future only for studies involving
Brookhaven researchers. All the work that we do is covered by a research
plan that is carefully reviewed and approved by Brookhaven's
Institutional Review Board. This Board operates under federal
regulations. All research with people must be closely examined and
approved before the work can begin. Any future research may involve only
Brookhaven scientists, or it may be part of a cooperation between our
researchers and people from other institutions. In that case, your
(data/blood/tissue) could be transferred to them after the Review Board
again has carefully reviewed and approved the work. Brookhaven will
never sell your (data/blood/tissue). The research done with it may lead
to new medical knowledge and treatments. The greatest risk to you from
Brookhaven keeping your (data/blood/tissue) is that information from
your records might be released. The chance of this happening is very
small. We have taken many steps to ensure that it does not occur. Please
consider our request and check off one of the following statements:

\_\_\_\_\_\_\_\_I agree to let Brookhaven to keep any extra
(data/blood/tissue) for future research.

\_\_\_\_\_\_\_\_ I do not agree to let Brookhaven to keep any extra
(data/blood/tissue) for future research.

We would be most pleased to have you take part in our study even if you
do not wish us to keep your (data/blood/tissue).

2\) We would like to take a little extra (data/blood/tissue) for future
research. If you agree to this, the (data/blood/tissue) will be kept in
a (data/blood/tissue) bank and may be used later to learn more about
(e.g., HIV, drug/alcohol addiction). Your (data/blood/tissue) will be
used in future only for studies involving Brookhaven researchers. All
the work that we do is covered by a research plan that is carefully
reviewed and approved by Brookhaven's Institutional Review Board. This
Board operates under federal regulations. All research with people must
be closely examined and approved before the work can begin. Any future
research may involve only Brookhaven scientists, or it may be part of a
cooperation between our researchers and people from other institutions.
In that case, your (data/blood/tissue) could be transferred to them
after the Review Board again has carefully looked at, and approved the
work. Brookhaven will never sell your (data/blood/tissue). The research
done with it may lead to new medical knowledge and treatments. The
greatest risk to you from Brookhaven keeping your (data/blood/tissue) is
that information from your records might be released. The chance of this
happening is very small. We have taken many steps to ensure that it will
not occur. Please consider our request and check off one of the
following statements:

\_\_\_\_\_\_\_\_I agree to let Brookhaven to take extra
(data/blood/tissue) for future research.

\_\_\_\_\_\_\_\_ I do not agree to let Brookhaven to take extra
(data/blood/tissue) for future research.

We would be most pleased to have you take part in our study even if you
do not want to let us take extra (blood, tissue).

3\) Brookhaven National Laboratory would like to keep any extra
(data/blood/tissue) that is left over from this study for similar
research in the future that has not yet been clearly described. If you
agree, this (data/blood/tissue) will be kept in a (data/blood/tissue)
bank. Your (data/blood/tissue) will be used in future only for studies
involving Brookhaven researchers. All the work that we do is covered by
a research plan that is carefully reviewed and approved by Brookhaven's
Institutional Review Board. This Board operates under federal
regulations. All research with people must be closely examined and
approved before the work can begin. Any future research may involve only
Brookhaven scientists, or it may be part of a cooperation between our
researchers and people from other institutions. In that case, your
(data/blood/tissue) could be transferred to them after the Review Board
again has carefully looked at, and approved the work. Brookhaven will
never sell your (data/blood/tissue). The research done with it may lead
to new medical knowledge and treatments. The greatest risk to you from
Brookhaven keeping your (data/blood/tissue) is that information from
your records might be released. The chance of this happening is very
small. We have taken many steps to ensure that it will not occur. Please
consider our request and check off one of the following statements:

\_\_\_\_\_\_\_\_I agree to let Brookhaven to keep any extra
(data/blood/tissue) for possible future research that has not yet been
defined.

\_\_\_\_\_\_\_\_ I do not agree to let Brookhaven to keep any extra
(data/blood/tissue) for possible future research that has not yet been
defined.

We would be most pleased to have you take part in our study even if you
do not want to let us take extra (blood, tissue).

4\) Brookhaven National Laboratory would like to take some extra
(data/blood/tissue) for similar research in the future that has not yet
been clearly described. If you agree, this (data/blood/tissue) will be
kept in a (data/blood/tissue) bank. Your (data/blood/tissue) will be
used in future only for studies involving Brookhaven researchers. All
the work that we do is covered by a research plan that is carefully
reviewed and approved by Brookhaven's Institutional Review Board. This
Board operates under federal regulations. All research with people must
be closely examined and approved before the work can begin. Any future
research may involve only Brookhaven scientists, or it may be part of a
cooperation between our researchers and people from other institutions.
In that case, your (data/blood/tissue) could be transferred to them
after the Review Board again has carefully looked at, and approved the
work. Brookhaven will never sell your (data/blood/tissue). The research
done with it may lead to new medical knowledge and treatments. The
greatest risk to you from Brookhaven keeping your (data/blood/tissue) is
that information from your records might be released. The chance of this
happening is very small. We have taken many steps to ensure that it will
not occur. Please consider our request and check off one of the
following statements:

\_\_\_\_\_\_\_\_I agree to let Brookhaven to take extra
(data/blood/tissue) for possible future research that has not yet been
described.

\_\_\_\_\_\_\_\_ I do not agree to let Brookhaven to take extra
(data/blood/tissue) for possible future research that has not yet been
described.

We would be most pleased to have you take part in our study even if you
do not want to let us take extra (blood, tissue).

**Blood Tests:** About teaspoons of blood will be taken from a vein in
your arm using a needle. The blood will be tested to determine your
general health and to make sure that you do not have any illnesses that
might prevent you from taking part in this study.

C

**Catheter Placement:** It is necessary to place a catheter (a thin
plastic tube) in a vein in your arm for the radiotracer injection. It is
necessary to place another catheter in your hand or wrist to obtain
blood samples for some of the measurements needed in this work. To ease
catheter placement, your hand will be warmed in a warming box (as you
saw in the video) for approximately 20 minutes before the catheters are
inserted. Since blood samples taken from an artery give better results,
the physician will determine whether the arteries that supply blood to
the hand are functioning properly. If they are, the catheter will be
placed in an artery in your wrist. If they are not, the catheter will be
placed in a vein in your hand. To decrease the discomfort, we may apply
a numbing medicine to your skin called lidocaine/prilocaine (such as
EMLA^®^) to the area where the catheters will be inserted. We will
inject a numbing medicine called lidocaine into the area where the
arterial catheter will be inserted. The catheters may be in place for up
to eleven hours on each day of the study. You will have saline (salt
water), which contains heparin (a medicine, which helps, prevent your
blood from clotting) flowing through each catheter for the entire study.

## Catheterization Risks:

There is a risk of pain, bleeding, bruising or infection from putting
the catheters in your arm. When we take out the catheter, someone from
the research team will press directly to the site of puncture to make
sure that there is little bleeding and bruising. If we put the catheter
in the artery in your wrist, you should not lift anything heavy or
exercise that hand for three days after the end of the study. We use
sterilized catheters to lessen the chance of an infection.

**Confidentiality:** Brookhaven National Laboratory will take all
reasonable measures to protect the privacy of your records and your
identity will not be revealed in any publication resulting from this
study. Your records include information that you provide to members of
the research team during your participation in this research project.
Your data may be used for different purposes. There are some
circumstances when Brookhaven is required by law to disclose certain
types of information, such as state requirements to report certain
communicable diseases. In addition, there is a possibility that your
study record, including identifying information, may be inspected by
officials of the Food and Drug Administration, the Office of Human
Research Protections of the US Department of Health and Human Services,
or other federal or state government agencies that regulate human
subjects research in the US in order to protect subjects participating
in such research. Representatives from the agency funding this research,
may also inspect the records.

**Certificate of Confidentiality**

To help us protect your privacy, we have obtained a Certificate of\
Confidentiality from the National Institutes of Health. With this
Certificate, the researchers cannot be forced to disclose information
that may identify you, even by a court subpoena, in any federal, state,
or local civil, criminal, administrative, legislative, or other
proceedings. The researchers will use the Certificate to resist any
demands for information that would identify you, except as explained
below. The Certificate cannot be used to resist a demand for information
from personnel of the United States Government that is used for auditing
or evaluation of Federally funded projects or for information that must
be disclosed in order to meet the requirements of the federal Food and
Drug Administration (FDA). You should understand that a Certificate of
Confidentiality does not prevent you or a member of your family from
voluntarily releasing information about yourself or your involvement in
this research. If an insurer, employer, or other person obtains your
written consent to receive research information, then the researchers
may not use the Certificate to withhold that information.

D

**Dopamine**

Dopamine is a natural chemical in the brain that is linked with
movement, the ability to think or concentrate, and pleasure.

E

**Electrocardiogram (EKG)**

A recording of the electrical activity of your heart, called an EKG will
be taken to make sure that there are no problems with the functioning of
your heart.

## G

# **GABA:** (Gamma-amino butyric acid) is a chemical that helps your nerve cells communicate with each other.

**Gadolinium:** Gadolinium is a contrast agent used in many medical
tests that makes it easier to see blood vessels or damage to tissue.

**Gadolinium Risks:**

There may be bruising and a little pain at the place where we place the
tube (catheter) in your arm to inject the contrast agent. Less often, a
small blood clot may form, or your vein may swell and the nearby tissue
may bleed. A few people have had bad reactions to the gadolinium
contrast agent. Some of these were headaches, dizziness, a metallic
taste in the mouth, nausea, and rash or hives. Very rarely, people show
severe allergic reactions. If you have had a bad reaction to a
gadolinium contrast agent before, be sure to tell us because then you
cannot take part in this study.

# At all times there will be emergency equipment and trained personnel in the facility to deal with an allergic reaction.

L

**Lumbar Puncture (Spinal tap):** This test will be performed to measure
the viral load and immune system chemicals in the spinal fluid.
Approximately one hour before the procedure, we will put
lidocaine/prilocaine (such as EMLA^®^) cream to numb the skin where we
will put the needle. You will lie on your side and after your lower back
is cleaned, a small needle will be inserted to inject a local numbing
medication (xylocaine) into the skin of your lower back. Next, a longer
needle will be inserted and approximately two tablespoons of spinal
fluid will be removed for both routine tests and for tests specifically
for this study. As with all parts of this study this test is optional
and, if you feel uncomfortable at anytime, it can be stopped.

**Lumbar Puncture risks:** The major risk of the spinal tap is pain on
the back where the spinal tap was done. Some individuals develop a
headache that can last for days; prolonged headache develops in only 1
in 50 to 1 in 200 subjects. This headache is usually relieved with
Tylenol (acetaminophen), drinking a lot of fluids and lying flat. A
persistent headache may result from continued spinal fluid leakage. If
the headache is not relieved after several days, the Responsible
Physician will assess you and may give you a "blood patch". This
involves drawing a small amount of blood from your vein and injecting it
into the area of the supposed leak to try and seal it. The blood patch
relieves the headache in most (95% in some studies) subjects. An
extremely rare complication of a spinal tap is injury to a nerve, or
infection. If at any time you decide that the spinal tap is too
uncomfortable, it will be discontinued.

## M

## Methylphenidate: Methylphenidate (brand name Ritalin) is a stimulant drug used to treat Attention Deficit Hyperactivity Disorder. Usually, tablets of 10 to 20 milligrams of methylphenidate are given to patients two or three times a day. 

## Methylphenidate Injection Administration:

In this study, we will inject a dose of about mg of methylphenidate
through the catheter in the vein in your arm. This amount is more than
the dose given for treatment and is given into your vein, rather than by
mouth. This makes the effects of the drug much stronger.

**Methylphenidate Injection Risks:**

When methylphenidate is injected into the vein in your arm, the effects
are much stronger than when it is given by mouth and you may feel "high"
and excited. Some people describe this as unpleasant because it makes
them feel anxious and out of control, and rarely, it may cause a
headache. It also may cause a loss of appetite, skin rash or hives,
dizziness, drowsiness, problems in moving, nausea, stomach pain or
fever. Methylphenidate may increase your heart rate and blood pressure
and may make it hard to sleep during the night after the study. We will
ask you not to exercise for the next 24 hours (including dancing or
partying), and also, not to take any drugs or alcohol afterwards. If you
have a history of seizures, anxiety, panic attacks or mental problems,
methylphenidate could make them worse. If you have any of these
conditions, you cannot take part in this study. Also, because
methylphenidate typically increases heart rate and blood pressure, you
cannot take part if you have heart trouble or high blood pressure or if
we find abnormalities in your EKG before the PET study. We will closely
check your heart rate, blood pressure and EKG during the scanning. A
physician certified in advanced cardiac life support will be present in
the PET laboratory at all times. If your blood pressure increases to
\>180 (systolic) or falls below 60 (systolic), or your heart rate
increases above 180 beats/minute or becomes irregular, the study will be
stopped, and your symptoms will be treated immediately. We cannot then
allow you to continue in the study. You will be checked and not be
allowed to leave the PET building until you are back to normal again.

## Methylphenidate Oral Administration Risks:

Methylphenidate will increase your heart rate and blood pressure and may
make it hard to sleep during the night after the study. Some people
describe these effects as unpleasant because it makes them feel anxious
and out of control. You might also loose your appetite, or develop a
skin rash or hives, dizziness, drowsiness, headache, nausea, stomach
pain, or fever, or your movements may be affected. We will ask you to
not exercise for 24 hours after the study (including dancing or
partying) and also not to take any drugs or alcohol afterwards. If you
have seizures, panic attacks, or mental illnesses methylphenidate may
make them worse. Therefore if you have any of these disorders or if you
have heart disease or high blood pressure, you must not participate in
these studies. A physician certified in Advanced Cardiac Life Support
(ACLS) will be present during the study at all times. We will carefully
check your heart rate and blood pressure and will not let you leave the
PET building until you are completely back to normal again.

# 

# **Michigan Alcohol Screening Test**

You will be asked to answer 25 "yes" or "no" questions to see how much
you depend on alcohol.

**MRI:**

MRI Magnetic Resonance Imaging (MRI) is a scanning system that uses a
strong magnet and radiowaves to generate pictures of your body.

We will be using an experimental MR machine at Brookhaven that has not
yet been approved by the Food and Drug Administration for routine use in
hospitals.

Functional MRI allows us to see the response of the brain to many
different functions you may be carrying out, such as seeing,
remembering, or moving parts of your body.

Magnetic Resonance Spectroscopy is a system that uses a strong magnet
and radiowaves to generate signals that record the amount of certain
chemicals in the body.

## MRI Procedure:

For the scan, we will ask you to lie on a padded table. The table will
move backward, placing you inside the MRI scanner. The scanner is shaped
like a tunnel and while you are inside it, we will ask you to lie still
so that the pictures of your brain being taken are not blurred. If you
think you might feel uncomfortable in a confined space, you can ask us
for a relaxing medication (sedative), taken by mouth (for example
Valium™), to help you relax during the scan.

## MRI Risks:

The MRI machine creates a strong magnetic field. If you have certain
metal objects in your body, for example, metal fragments, non-removable
hearing aids, nerve stimulators, or pacemakers, you cannot enter the
scanner and so cannot take part in our study. You may be bothered by
feeling claustrophobic ("feeling enclosed") while in the scanner.
Because the MRI makes loud "knocking" noises, we will ask you to wear
earplugs. Also, when the MRI makes the "knocking" noise, you might feel
a tingling sensation in your arms or legs, but this is unlikely. You
also may become dizzy or have a metallic taste in your mouth if you move
your head quickly while you are in the scanner. The radio waves produced
by the scanner could cause you to feel warm, but again, this is
unlikely. Although we do not know for certain whether there is any
long-term risk from being in a MRI scanner, based on information
collected over the past 20 years, we do not know of any.

## P

## PET 

## Positron Emission Tomography (PET) is an imaging system that takes pictures of what the body is doing using a special camera and a radioactive chemical called a radiotracer. This radiotracer is injected into the bloodstream in very small amounts and the PET camera takes pictures of the movement of the radiotracer in the body. The Brookhaven Radioactive Drug Research Committee, a group consisting of both physicians and scientists with special knowledge of how to use radioactive tracers, has looked carefully this study. They have approved the use of the radiotracer, and the amount that we will use. The amount of radioactivity you will receive is within the limits set by Federal safety guidelines.

## PET Procedure

We have described what we will do in the PET Brochure that you were
given and in the video that you saw. We will ask you to lie on your back
on a table, which will move until you are in the PET. We will draw
colored lines on your head with a washable marker so that we can line
you up the PET and you will have a 15-minute scan to check that you are
correctly placed. When the PET camera is ready to take pictures of your
brain, *talk about the specific radiotracer and/or drug to be
administered*. You will need to lie still for approximately minutes for
each scan. During this time, we will take about tablespoons of blood
through the tube (catheter) in your wrist to measure elements in your
blood. Altogether, you will have [scans]{.underline}, so the total
amount of blood taken will be about tablespoons. At the end of each
scan, you will be taken to the bathroom to urinate so that your bladder
is exposed to as little radiation as possible.

## Placebo

A placebo is an inactive substance, similar in appearance with a drug
being tested in experimental research. When it is given during research,
the volunteer does not know which is which.

# **Pregnancy**

If you are a woman of childbearing age, we will ask you for a sample of
urine that will be tested to see if you are pregnant. If you are
pregnant, you cannot be in the study. We will test for pregnancy on
every day that you take part in the study.

#### 

#### R

**Radiotracer Risks:**

There is a small possibility of an allergic-type reaction from injecting
the radiotracer. So far, however, no such reactions have been reported.

**Radiation Exposure:**

To help you understand the amount of radiation you will get by being in
this study, we will compare the radiation from this study to amounts you
encounter in everyday life. Everyone receives a small amount of
unavoidable radiation each year, some of which comes from space, some
from medical procedures and some from naturally occurring radioactive
forms of water and minerals. The radiation dose in the United States
from such sources ranges from 100 and 1000 millirem (mrem) each year.
Mrem is a unit used to measure radiation dose. Standard medical
procedures use x-rays or other forms of radiation. For example, the
radiation dose for a chest x-ray is 10 mrem and for an intestinal x-ray
is 500 mrem. The radiation dose from this study will be no more than
mrem. This amount of radiation falls within the guidelines set by the
Food and Drug Administration (FDA) for research.

  

There have been no detected adverse health effects in individuals for
radiation doses less than 10,000 mrem. However, according to a report
published by the National Academy of Sciences in 2005, small doses of
radiation may present some increased level of health risk even though
this increase has not been clearly established. Based on this report,
the dose you receive in this study (\_\_\_\_ mrem) may result in a very
small increase in your risk of adverse health effects.

**Research Results:** The research materials and research data that are
produced as a result of your participation in this study are the
property of the Brookhaven National Laboratory. If a commercial product
is developed from this research project, such as a new drug, you will
not have any ownership interest in this product and will not profit
financially from such a product.

# S

## Smoking

[Breath Test for Carbon Monoxide and Tobacco Questionnaire:]{.underline}
We will ask you to take a deep breath in, to hold it for as long as you
can, and then to breathe out slowly and steadily through the mouthpiece
of our instrument. This test will show if you have smoked recently or
have been with people who smoke. We will also ask you eight simple
questions about your smoking habits to see if you depend on smoking
tobacco. We need this information to see if smoking or being near other
people who smoke is related to differences in each person's results.

# **Stimulant Drugs**

If you have been addicted to any substance in the past, or if you are
curious about stimulant drugs, you should not take part in this study.
Getting the drug in this study might bring back or start your addiction.

Please initial here to show that we warned you about this and that you
are aware of this risk.

# U

# **Urine toxicology**

Urine Test: We will ask you to give a urine sample. It will be tested
for several drugs, including marijuana, cocaine, PCP, benzodiazepines
(such as Xanax or Valium), amphetamines (such as "crystal"), opiates
(such as heroin) and barbiturates ("downers"). This test ensures us that
you have not taken drugs before your PET and/or MRI scan. If you had,
this might interfere with our measurements. If you return to take part
in this study on another day, these tests will be repeated then. A
positive test for drugs (*change if applicable, i.e. positive for
cocaine for a study of active addicts.)* If either of these occurs,
*(modify as needed)* we will tell you that you are not eligible for the
study and you will not be paid for taking part in the screening.