 Introduction
Doctors still do not know which medication is best for detoxifying
heroin addicts. The National Drug Abuse Treatment Clinical Trials
Network (CTN) is doing a study called BUP/NX versus Clonidine for
Opiate Detoxification: A Medication Comparison Study to find out
which of two medications may be better for patients who are entering
opioid detoxification.
The purpose of this study is to test two different medications to
treat opiate withdrawal during detoxification. Both medications will
be provided free of charge.
The medications that will be tested are:
1. Clonidine -- commonly used to treat symptoms
of opiate withdrawal; it comes in a pill that you will take at the
beginning of the study and then a "patch" that you wear during treatment.
You may or may not continue taking the pills.
2. BUP/NX -- is a combination of buprenorphine
and naloxone. Buprenorphine is an analgesic that is being investigated
as an alternative to methadone treatment. Naloxone is an opioid antagonist
used to prevent opiate overdose. The combination comes in a pill that
you hold under your tongue until it dissolves.
There are many other types of treatment for opioid dependence available
to you. You are being asked to take part in this study to help find
the best medication for people like yourself who want to detoxify
from opioids.
You may choose not to take part in the study. If you choose not
to take part, your treatment will not be affected in any way and you
will not lose any of the treatment services you would normally receive
at this clinic.
If you are interested in taking part in the study, an intake counselor
or study coordinator will need to get your written permission before
joining. You will need to understand and sign an informed consent
paper. You may ask as many questions as you want to help you decide
whether or not to join. Also, your doctor, nurses and research assistants
will interview you to determine if you are qualified to participate
in the study. This is called the screening/baseline phase. You will
be paid $25 for completing this phase. This phase includes:
If you take part in the study, here is what you can expect:
1. You will be assigned at random to receive one of the medications
for detoxification (that means you will not have the choice of which
medication you will get). Two out of three people will be assigned
to get BUP/NX, therefore you are twice as likely to get assigned
to the BUP/NX than the clonidine group. If you decide to take part
in this study you must be willing to take either of the medicines
you may be assigned.
2. Your doctor will discuss with you the medication that you will
be receiving and give you instructions on how to take it.
3. Your doctor will follow you closely while you are on the medication.
You may be given other medications for treating symptoms that come
up while you are detoxifying from opiates (for example, for nausea,
diarrhea, or sleeplessness).
4. You will often meet with a research assistant as well as study
doctors and nurses. The research assistant will collect important
information from you, help you fill out questionnaires, collect
urine samples, contact you for follow-up visits, and help with answering
any of the questions you might have.
5. You will need to give a urine sample several times during the
study. These will be tested for opiates, methadone, cocaine, amphetamines,
marijuana, and benzodiazepines.
6. You will need to return to the clinic 1, 3, and 6 months after
starting the study for a follow-up interview and to give a urine
sample. You will be paid for each interview ($25 in gift certificates
or by another form of payment to be decided on by your treatment
program). If you return for all of these interviews, you will be
paid an extra $25.
7. All of the information that you give us, including urine test
results, will be kept confidential.
Questions about the study
These are the answers to some questions about the study that may
help you decide if you would like to take part in the study.
1. How long will I be in the study?
You will get medications for about two weeks and then return for
follow-up visits at 1, 3, and 6 months. Therefore, you will be in
the medications phase for about two weeks and in the follow-up phase
for up to 6 months.
2. How many people will be taking part in the study?
At least 360 people across the United States will take part in
the study.
3. What will I have to do during the study?
There are a few things that you will have to do above and beyond
your regular treatment if you decide to take part in the study,
such as:
- Take your study medication as your doctor prescribes
4. Can women who are able to have children take part in the study?
Yes. However, because the safety of the study medications is not
fully known, women who are able to have children should avoid becoming
pregnant while in the medication phase of the study. If you are
a woman able to have children, you will need to use birth control
during the study and you will get a pregnancy test prior to participating.
Acceptable methods of birth control will be discussed with you before
you agree to participate in the study. Be sure to call your doctor
right away if you think you are pregnant during the study.
5. What will happen if I become pregnant while in the study?
If you become pregnant during the study, your study doctor will
discuss your choices with you. Your choices will depend on when
you became pregnant during the study. In any case, your doctor will
want to know what happens to you during your pregnancy and when
your baby is born.
6. What happens at study follow-up visits?
Study follow-up visits include:
- Questions about your health and how you are feeling
- Questions about drugs or other medications you are taking
- Questions about how you are doing in different areas of your life
(for example, family/social, legal, employment areas)
- Providing a urine sample
The study follow-up visits will take about one hour each to finish.
7. What will I get for taking part in the study?
The medications used in this study may help with your withdrawal
symptoms during detoxification. You will get additional monitoring
of your symptoms during the study, which might not be available
to you otherwise. Finally, you will receive up to $125 worth in
cash or goods for doing the screening/baseline and all follow-up
interviews.
8. Will I have any bad effects from taking part in the study?
The medications used in this study have many possible side effects.
During your participation in this study, you will be watched for
known side effects of the medications you will be taking. Still,
some side effects may be harmful, some may be unknown. The study
medications may conflict with other prescription or over-the-counter
medications, or interact with illegal drugs or alcohol to produce
side effects. Therefore, you should ask your doctor before taking
any medication.
You should know the possible side effects of a medication before
you decide to take it. Your informed consent paper will list the
side effects for each of the medications you will take.
Also, much of the information collected during the study is sensitive
and there is a risk that others who are not involved in the study
will see it. However, this is a relatively small risk since the
investigators and staff are well-trained in keeping the information
confidential. Your name will not appear on any of the information
you give us. Instead, you will be assigned an ID number that will
be used on all forms. In addition, all information collected from
study volunteers will be kept in locked areas in this clinic.
For more information on the National Drug Abuse Treatment Clinical
Trials Network, visit the NIDA website at www.drugabuse.gov.
For information on other clinical trials, the National Institutes
of Health (NIH) has created a website to help patients, family members,
and the general public obtain information about government sponsored
clinical trials. You may log on to www.Clinicaltrials.gov
to learn about ongoing or new trials for all types of health related
conditions. The descriptions for individual trials include eligibility
criteria, purpose of the trial, location, and how to apply if interested.
The website is maintained and updated regularly by the National Library
of Medicine.
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