Clinical Efficacy of Atomoxetine for Methamphetamine Dependence

During the study participants will spend the initial 2-weeks of the study at an inpatient
facility. This will help participants initiate withdrawal. During the following 8-weeks the
participant will come in for 3-4 visits each week. Three of these visits will be with the
research assistants and one visit will be with a therapist in order to work with the
participant using a cognitive behavioral therapy approach. Therapy visits are typically
scheduled on a day that the participant is coming for clinic anyways so the number of visits
per week is typically 3. During the 10-week period the investigators will collect vitals,
cognitive assessments, mood assessments, ratings of feelings of withdrawal, urine drug
screens, weekly use reports of methamphetamine, and any reports of symptoms or side effects.
This will tell the investigators if atomoxetine helps relieve methamphetamine withdrawal
symptoms and will tell us if a participant lapsed or relapsed.

Inclusion Criteria.

- 18-65 years old

- Seeking treatment for METH use

- METH dependence, as assessed by the substance abuse section of the Structured
Clinical Interview for DSM-IV.

- At least weekly self-reported METH use during a preceding three month period

- Women of childbearing age must have a negative pregnancy test, agree to adequate
contraception to prevent pregnancy during the study, agree to monthly pregnancy
testing, and not be nursing

- Men must agree to use effective means of contraception during the study.

Exclusion Criteria.

- Suicide attempts within the past 12 months or either suicidal ideations or psychotic
symptoms in the past 6 months as determined by a study physician.

- Current opioid, alcohol or sedative physical dependence or cocaine dependence

- Major cardiovascular disorder that contraindicates study participation (e.g., history
of myocardial infarction, stroke, congestive heart failure, cardiac arrhythmia,
hypertension [i.e., > 160 SBP or > 100 DBP] or an unstable medical condition (e.g.,
untreated bacterial infection) as determined by the study physician.

- Schizophrenia or bipolar disorder of any type

- Present or recent use (within 2 weeks) of over-the-counter or prescription drug that
would be expected to have major interaction with atomoxetine (e.g., an monoamine
oxidase inhibitor (MAOI), paroxetine, fluoxetine, quinidine, dopamine, albuterol, or
other β2-agonists)

- Medical contraindication to receiving atomoxetine (e.g., severe hepatic impairment,
glaucoma, heart disease, hypertension, seizure disorders, documented hypersensitivity
to atomoxetine); or other bronchospastic condition, (2nd or 3rd degree AV block, sick
sinus rhythm, severe hepatic impairment, documented hypersensitivity to atomoxetine)

- Liver function tests (i.e., liver enzymes) greater than two times normal levels

- Systolic blood pressure of < 90 or > 160 mmHg, diastolic blood pressure of < 60 or >
100 mmHg, or sitting heart rate of < 55 or > 100 beats/min or blood pressure readings
> 140 systolic or > 90 diastolic on three separate, consecutive occasions.

- History of pheochromocytoma

- Pregnant or nursing female