Atomoxetine for Treating Cocaine Abuse in Adults With Attention Deficit Hyperactivity Disorder (ADHD)

ADHD is a neurologic disorder that is thought to be caused by chemical imbalances of certain
neurotransmitters in the brain. The disorder can cause inattention, hyperactivity, and
impulsivity. Cocaine abuse rates in adults with ADHD are significantly higher than they are
in adults who do not have the disorder. This may be reflective of an attempt by individuals
with ADHD to self-treat symptoms. Atomoxetine is an FDA-approved drug that is used to
increase the ability to pay attention and decrease impulsiveness and hyperactivity in
children and adults with ADHD. The drug is in a class of medications called selective
norepinephrine reuptake inhibitors and works by increasing the levels of norepinephrine, a
natural substance in the brain that affects a person's attention and impulsivity. It is
possible that reducing ADHD symptoms in cocaine abusers with ADHD will help decrease their
need for cocaine. This study will evaluate the effectiveness of atomoxetine in reducing
cocaine use in people with ADHD who abuse cocaine.

Participants in this open label study will receive atomoxetine for 12 weeks, and will take
one dose each morning for the duration of the study. Doses will be increased gradually to
minimize side effects and enhance treatment compliance. In addition, all participants will
receive individualized relapse prevention therapy once weekly. Participants will be required
to report to the study site three times a week to receive medication, complete questionnaires
regarding ADHD symptoms and substance use behavior, and provide a urine sample while being
supervised by study staff. Also, vital signs will be monitored and medication side effects
will be assessed at each visit. Participants will report to the study site 6 months after
starting in the study for a follow-up visit, at which time ADHD symptoms, substance use
behavior, and social functioning will be assessed.

Inclusion Criteria:

- Meets DSM-IV criteria for cocaine dependence and adult ADHD

- Describes cocaine as the primary drug of abuse

- Meets DSM-IV criteria for cocaine dependence

Exclusion Criteria:

- Meets DSM-IV criteria for current Axis I psychiatric disorders that require a
psychiatric intervention (except ADHD or substance abuse)

- Current major depression

- Unstable physical disorders that might make participation unsafe (e.g., uncontrolled
high blood pressure and tachycardia [systolic blood pressure greater than 150 mm Hg,
diastolic blood pressure greater than 90 mm Hg, or a sitting heart rate greater than
100])

- Acute hepatitis (individuals with chronic mildly elevated transaminase levels of less
than 2 or 3 times the normal limit are not excluded)

- Diabetes

- Coronary vascular disease, as indicated by a history or suspected by an abnormal
electrocardiogram

- History of cardiac symptoms

- History of seizures

- Narrow angle glaucoma

- Use of monoamine oxidase inhibitors (MAOIs) within 2 weeks of starting treatment with
atomoxetine

- Currently taking prescribed psychotropic medications

- Currently taking medications for the treatment of ADHD

- Known sensitivity to atomoxetine

- Current suicidal ideation or history of suicidal or homicidal behavior within 2 years
prior to study entry

- Pregnant or breastfeeding

- Physiologically dependent on any drugs other than nicotine or marijuana

- History of schizophrenia, bipolar disorder, or other psychotic disorders

- Currently taking cough medicine (e.g., dextromethorphan) and/or albuterol