 Introduction
Your clinic is going to participate in a clinical trial to study
the effects of treatment for quitting smoking in community substance
abuse rehabilitation programs. The treatment for quitting smoking
will last for 9 weeks and consists of the NicoDerm CQ nicotine skin
patch in combination with counseling. The study will assess whether
adding this treatment for quitting smoking to existing treatment for
substance abuse results in higher rates of abstinence from drugs and/or
alcohol. The study will also examine whether the smoking cessation
treatment helps people quit smoking, keeps them in substance abuse
treatment longer, and works well in a community substance abuse rehabilitation
setting.
The study includes 3 follow-up visits, so each participant will
be enrolled for 26 weeks. This pamphlet gives an overview of this
study. It also answers questions you might have about your involvement
with the study. More information about clinical trials in general
can be found in the National Drug Abuse Treatment Clinical Trials
Network brochure, What are Clinical
Trials?
Why is it important to study this question?
Many people who abuse drugs and alcohol also smoke cigarettes. Cigarette
smoking is associated with nicotine addiction. Nicotine addiction,
like addiction to drugs and alcohol, is difficult to break. Smokers
may need medication and/or counseling to help them stop smoking. Quitting
smoking is important, because smoking poses significant health risks
that add to the risks of substance abuse. Quitting smoking may make
it easier for some people to stop using drugs and alcohol. By adding
treatment for smoking, patients may stay in substance abuse treatment
longer. Unfortunately, there is very little information available
to guide practitioners on how best to help substance abusers quit
smoking. Even less is known about whether or how to incorporate smoking
cessation treatment into existing community substance abuse rehabilitation
programs. This study is likely to be an important step towards addressing
these questions.
Why is the nicotine patch being tested?
The nicotine patch addresses nicotine addiction by replacing some
of the nicotine lost after quitting smoking. The nicotine patch releases
a small amount of nicotine into the body through the skin. The amount
of nicotine released from the patch is enough to at least reduce smoking
withdrawal symptoms, and, in many people, to make quitting easier.
The nicotine patch is easy to use, is well tolerated, and can be purchased
over the counter.
How will this study affect our current treatment procedures?
All of the participants in this study will take part in the usual
substance abuse treatment offered by your clinic. Clients who want
to enroll in this study will have to undergo screening to make sure
they meet the eligibility criteria for the study. Clients who meet
criteria and pass the screening tests will be randomly assigned (like
the flip of a coin) to one of the smoking cessation treatment groups.
Two-thirds of the participants will get smoking cessation treatment
while they are in the study. The other one-third of participants will
get smoking cessation treatment after completing the study (about
26 weeks later). Participants will also be assessed at three follow-up
visits at weeks 9, 13 and 26 following their target “quit date.”
The study visits will be separate from the substance abuse treatment
appointments and should not interfere with treatment as usual.
Why are participants assigned to treatment groups randomly, and
why do some have to wait to get smoking cessation treatment?
Random assignment is the best method for assigning participants to
treatments because it helps to balance treatment groups. If participants
were allowed to choose, it is possible that most participants of a
certain gender, race, or severity of dependence would choose to be
in one of the groups. If this happened, it would be hard to know if
a difference in treatment outcome was related to the intervention
or to one of these other factors. Random assignment will help to reduce
the possibility of an imbalance in study groups related to participant
characteristics. Comparing patients who receive smoking cessation
treatment during drug treatment with those who receive it after enables
us to compare groups while still allowing everyone to get active treatment.
How will participating in this study change our current practices?
For the most part, conducting research in the clinic should not have
a big impact on how you interact with clients. Clients participating
in the study will be screened more extensively than those not participating.
Care will have to be taken to ensure that no study data are collected
before documentation of informed consent.
Different, and perhaps more strict, rules for maintaining confidentiality
and privacy apply in the case of research. For example, the fact that
a client is participating in a study may have to be kept confidential
from other staff, and definitely should not be discussed in common
areas or mentioned to other clients.
Participating in research is likely to increase the amount of paperwork
needed for clients who enroll, and some information may need to be
recorded in a location separate from clinic records. Since much of
the information being obtained in this study is research-related but
not directly treatment-related, it may have to be handled and filed
separately. Research-related data will need to be coded so that patient
confidentiality is maintained.
What are the benefits to our clinic from participating in this clinical
trial?
There are several possible benefits to participating in a clinical
trial. First, taking part in this study will give therapists an opportunity
to learn techniques that are not yet commonly used in community substance
abuse rehabilitation programs. These techniques will be helpful in
work with clients for many years to come, and will put your clinic
in a unique position to deliver state-of-the-art smoking cessation
treatment. Second, participation in this trial will provide your patients
with access to new treatment strategies that may support them in their
efforts to stay off drugs. Third, clinic staff will receive training
and experience in carrying out clinical trials that may be useful
in future research efforts. Finally, your clinic will play an important
role in advancing our knowledge of effective treatment strategies
for this population.
What should I tell clients about the Clinical Trials Network and
the “Stop Smoking Study”?
Clients who smoke should be told that the clinic is participating
in a national study of a stop smoking treatment program in community
substance abuse rehabilitation programs. Clients who express interest
and would like more information should be referred to informational
handouts developed by the National Drug Abuse Treatment Clinical Trials
Network. As a staff person in a participating clinic, you should familiarize
yourself with these brochures so that you can answer questions and
refer potential participants to the right sources. “What
are Clinical Trials?” is an excellent source for understanding
the benefits of participating in a research study. “Should
I Join the Stop Smoking Study?” is a brochure for clients
that describes the smoking cessation study in general terms that potential
participants can easily understand. More specific information about
the study can be found in the Informed Consent Form that the research
assistant will read with a client who is deciding whether or not to
participate. Since your clinic will be participating in this study,
you will receive training in how to talk with the clients about the
research project. If you ever find yourself unable to answer a question
about the research, you should consult with your supervisor, the research
assistant, node coordinator, or an investigator for more information.
For More Information
More information on the National Drug Abuse Treatment Clinical Trials
Network can be found at www.drugabuse.gov.
Go to www.Clinicaltrials.gov
to learn about other studies sponsored by the government. Information
on who can take part and where and why the study is being done are
available. Instructions on how to apply for studies are also on this
site.
National Institute on Drug Abuse
Center for the Clinical Trials Network
6001 Executive Blvd., MSC 9557
Bethesda, MD 20892-9557
Telephone: 301-443-6697
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