Trial Information

Smoking Cessation Intervention for Depressed Smokers: Treatment Development

During the session today, you will be asked to complete 8-9 questionnaires about smoking
history, health status, current medications you are taking, your confidence in quitting
smoking, symptoms of nicotine dependence and withdrawal, symptoms of depression, negative
experiences during childhood, and your thoughts and feelings about work and the quality of
your relationships with others. In total, the questionnaires should take about 30-45 minutes
to complete. You will also blow into a machine that measures the amount of carbon monoxide
in your blood (a breath test). This visit may last 1 ½ to 2 hours.

Following the session today, you will be provided with information on the results of the
screening tests you completed at BCM to see whether you have a current depressive disorder
or any other psychiatric disorders. You will be provided with an opportunity to discuss this
information with the investigators.

If you are found to be eligible to take part in this study, you will be randomly assigned
(as in the toss of a coin) to one of 2 groups. If you are assigned to Group 1, you will
receive counseling to help develop behavioral coping skills that will help with situations
where you are tempted to smoke more (which are considered high-risk situations), combined
with mood management counseling to help you develop interpersonal (communication) coping
skills to help with depression and negative moods that may affect your ability to quit
smoking. If you are assigned to Group 2, you will receive counseling to help develop
behavioral coping skills that will help with situations where you are tempted to smoke more
(which are considered high-risk situations), combined with education on the health-related
effects of smoking. Participants in both groups will receive nicotine patches.

During the 5 weeks after the visit, you will have six (6) 70-minute counseling sessions.

If you are in Group 1, you will receive information on how cigarette smoking is a learned
habit and a physical addiction and how the habit can be unlearned. You will receive
counseling to help you identify situations that are high risk for smoking and to help you
develop behavioral coping plans to decrease the chances of smoking in those situations. You
will be encouraged to use these skills between sessions. You will also receive counseling
to help you identify situations where you interact with others that may cause negative
moods. You will be taught interpersonal coping skills to help decrease depression and
negative moods and to increase your ability to quit smoking and not start again. You will
be given homework assignments that will help you practice these skills between sessions.

If you are in Group 2, you will receive information on how cigarette smoking is a learned
habit and a physical addiction and how the habit can be unlearned. You will also receive
counseling to help you identify situations that are high risk for smoking and to help you
develop behavioral coping plans to decrease the chances of smoking in those situations. You
will be encouraged to use these skills between sessions. You will also receive information
about health issues related to smoking and you will have the opportunity to discuss this
information with your counselor.

Before or after each of the counseling sessions, you will fill out 2-3 questionnaires on
mood and smoking behavior and have a breath test. You will be asked to fill out 5-6
questionnaires on withdrawal symptoms, confidence in quitting smoking, your thoughts and
feelings about work, and the quality of your relationships with others. In total, it will
should about 30-45 minutes to fill out the questionnaires at each visit. Each of these
visits will take a total of about 1 hour and 40 minutes to 1 hour and 55 minutes.

The date to quit smoking will be scheduled for about 5 weeks after your first visit. As
part of your counseling sessions, you will be provided with counseling to help you develop a
plan to quit and to set a quit date. You will be given the nicotine patches starting on the
quit date. You will be asked to wear the nicotine patches on the upper area of your body
for 24 hours each day.

Following the quit date, you will attend six (6) more 70-minute counseling sessions. You
will also attend 2 additional visits at 3 months and 6 months from your quit date. At each
of these visits, you will be asked to fill out 2-3 questionnaires on mood and smoking
behavior and to provide a breath test to measure the amount of carbon monoxide in your
blood. You will be asked questions about symptoms you may be having and the medications you
are taking. You will be asked to fill out 5-6 questionnaires on withdrawal symptoms,
confidence in quitting smoking, and the quality of your relationships with others at some of
these visits. If you are unable to attend your end-of-treatment, 3-month or 6-month visits,
you may be asked to provide a saliva sample to measure the amount of cotinine in your blood,
a chemical produced by the breakdown of nicotine during smoking. This sample will be taken
using a dental roll (cotton swab) placed in the mouth for several minutes to absorb saliva.
At the 3-month and 6-month follow-up visits, you will be also asked questions about any
current problems with depression.

At the last treatment visit (Visit 12) and at the 3-month and 6-month follow-up visits, if
you are still smoking, you will be provided with information on where you can receive
additional help to quit smoking. If you continue to have a current depressive disorder, you
will be provided with additional information about this disorder, and you will be provided
with information on where you can receive treatment for your depressive disorder. The
investigators will provide a referral for treatment if you wish to receive treatment for
your depressive disorder at that time.

Each of the counseling visits will be videotaped. In addition, the first visit and the
visits at 3 and 6 months may also be videotaped. The videotapes will be erased within 1
year after you complete this study. The videotapes will be used to help the investigators
make sure that the counselors are following the correct therapy procedures and may be used
in future studies to help the investigators better understand the mood management and health
education treatments. No one but the study investigators, study staff, and consultants
(those who review and rate how well the study therapists follow therapy procedures) will be
allowed to view the tapes. Your identity will be kept strictly confidential.

So that the study researchers can keep in contact with you throughout the study and over the
long period of time between your end of treatment visit and the 3- and 6- month follow-up
visits, you will be asked at the baseline visit to provide the name and address of 2
contacts (family members/friends) that you feel confident would have updated contact
information on you.

Your participation in this study will end after the 6-month follow-up visit.

This is an investigational study. The nicotine patches are FDA approved for use in adults
age 18 and older and commercially available. Up to 202 people will take part in this study.
All will be enrolled at M. D. Anderson.