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ADHD in Adoloscent Substance Abusers
Treatment
Study Designed for Your Teenager
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| Introduction
Approximately 30-50%
of adolescents in the United States who abuse
drugs also have ADHD. The symptoms of ADHD include
difficulty sustaining attention, distractibility,
procrastination, difficulty organizing and completing
tasks, misplacing items,
restlessness, impulsivity, and talking out of
turn.
Research shows that as many as one-half of adolescents
in drug treatment programs have ADHD, which is
associated with more severe drug use, behavior
problems, more drop outs, and treatment failure
when compared to adolescents with substance-dependence
without ADHD.
One reason for poor treatment outcomes is that
the majority of adolescents in community-based
treatment programs may not receive medication
for their ADHD while in treatment for their drug
use.
The purpose of this study is to find out if Osmotic-Release
Methylphenidate (OROS-MPH), a medication approved
for the treatment of ADHD, compared to placebo
(sugar pill), can help adolescents with drug and
alcohol problems.
Your teenager will be eligible to participate
if he/she is between 13 and 18 years old, has
ADHD and is willing to take a medication / placebo,
has drug/alcohol problems, and is willing to participate
in the study’s outpatient Cognitive Behavioral
Therapy (CBT) to help his or her drug/alcohol
use. |
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If your teenager decides to join, what will happen
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1. If under 18, your teenager will contact the research
clinic and complete a confidential telephone screening
to see if he/she might be eligible for the study.
2. If your teenager qualifies for the study, based
on a pre-screening questionnaire, he/she will be
scheduled for an appointment at the research clinic.
At this visit, the study will be explained to you
both in detail and then your teenager will be asked
more questions (in private) about his/her drug/alcohol
use as well as medical history, including ADHD.
3. If your teenager qualifies after the initial
screening phase, he/she will have the
following: a physical exam and vital signs measured;
a small amount of blood taken to make sure he/she
is healthy (and a test for pregnancy if female),
his/her urine tested for drugs of abuse, and an
ECG to measure the activity of your child’s
heart. Your teenager will also answer more questions
(in private) about his/her drug use and ADHD.
4. If all study criteria are met, your teenager
will be assigned at random (for example, with the
flip of a coin) to receive either OROS-MPH or placebo
and will be asked to take the OROS-MPH or placebo
every day for 16 weeks.
5. Your teenager will spend about 2 hours at the
clinic each week. During that time, he/she will
participate in Cognitive Behavioral Therapy (CBT)
sessions that last about 1 hour.
6. Your teenager will be asked questions about his/her
drug use and ADHD and will be asked to give a urine
sample. The samples will be tested for drugs of
abuse.
7. Your teenager will also meet with a medical clinician
during those times to check how he/she is feeling
and to be sure he/she is not having any bad reactions
to the study medications.
8. At the end of the 16-week study, your teenager
will again have a small amount of blood taken.
9. Your teenager will come back for a follow-up
visit 1 month after his/her last study visit.
10. All of the information collected in the study will be kept confidential.
11. This study is entirely voluntary and you and your teenager can withdraw at any time without any penalty to either of you.
Questions
How long will my teenager be in the study?
Your teenager will be in this research study
for about 5 months.
How many other people will be in the study?
About 300 adolescents from across the United
States will be in the study.
Will my teenager receive anything for participating?
Yes, your teenager will be given compensation
for his/her time and for travel while participating
in this study.
Will my teenager have any bad effects from
taking part in this study?
Your teenager may experience side effects
due to the medication used in this study. During
his/her participation in this study, your teenager
will be watched for known side effects of the
medication he/she will be taking. Still, some
side effects may be harmful and some may be unknown.
The study medication may conflict with other prescriptions
or over-the-counter medications or interact with
illegal drugs or alcohol to produce side effects.
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
because the
investigators and their staffs are well trained
in keeping the information confidential. Neither
yours nor your teenager’s name will appear
on any of the information you or your teenager
give us. All information collected from study
volunteers will be kept in locked areas in the
clinic.
What are the benefits of CBT?
CBT has been shown to;
1) reduce substance abuse & relapses by exploring
and tracking patterns of use;
2) improve family relationships;
3) enhance performance at school;
4) advance communication skills;
5) develop anger management skills; and
6) develop job seeking skills. The treatment includes
one 60-minute session each week of the study,
with three being family sessions.
For More Information
For more information on the National Institute
on Drug Abuse Clinical Trials Network, visit the
NIDA web site at www.drugabuse.gov.
For information on other government sponsored
clinical trials, the National
Institutes on Health (NIH) has created a web site
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 of 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 web site is maintained
and updated regularly by the National Library
of Medicine.
National Library of Medicine.
National Institute on Drug Abuse
Center for Clinical Trials Network
6001 Executive Boulevard, MSC 9557
Bethesda, Maryland 20892-9557
Telephone: (301) 443-6697
Fax: (301) 443-2317
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