Effectiveness of Bupropion Combined With Behavioral Therapy for Treating Methamphetamine Dependence - 2

Methamphetamine is a drug that causes excess amounts of the neurotransmitters dopamine and
norepinephrine to be released into the brain. This overload produces unusual alertness and
feelings of elation. When the body undergoes methamphetamine withdrawal, it experiences a
reduction in dopamine and norepinephrine. Bupropion is an antidepressant used for the
treatment of depression and smoking cessation. Because it functions by increasing the
release of dopamine and norepinephrine in the brain, bupropion is likely to decrease the
negative effects of methamphetamine withdrawal. The purpose of this study is to evaluate the
efficacy of bupropion combined with contingency management (CM) and cognitive behavioral
counseling (CBT) as a means of treating methamphetamine dependence.

An initial 2-week screening process will involve participants providing urine samples and
completing physical and psychological assessments. If deemed eligible for the remainder of
this double-blind study, participants will be randomly assigned to receive either bupropion
or placebo over the course of 12 weeks. Participants in both the bupropion and placebo
groups will receive contingency management and cognitive behavioral counseling. Participants
will report to one of two clinical research sites three times per week. At each visit,
participants will be examined by the study staff, provide a urine sample, and receive
individual cognitive behavioral counseling sessions. At the end of 12 weeks, treatment will
be stopped. Participants will return to the study site 30 days later for evaluation and to
be assessed for any possible lingering side effects.

Inclusion Criteria:

- Meets DSM-IV criteria for methamphetamine dependence

- Females must use an effective method of contraception

Exclusion Criteria:

- History of or current medical condition that might interfere with safe participation,
such as active tuberculosis, unstable heart or liver disease, unstable diabetes,
symptomatic AIDS (non-symptomatic HIV infection is not an exclusion), or greater than
8 times the upper limit of normal in liver screening function tests (SGOT or SGPT)

- Current neurological disorder (e.g., organic brain disease, dementia)

- Major psychiatric disorder unrelated to substance abuse, such as schizophrenia or
bipolar disorder (assessed by the SCID and a medical history)

- Suicide attempt within the month prior to enrollment and/or currently suicidal
(assessed by the SCID and the BDI II)

- Currently on prescription medication that might interact with the study drug

- Currently dependent on cocaine, opiates, alcohol, or benzodiazepines, as defined by
DSM-IV-TR criteria

- History of alcohol dependence within past three years

- History of seizure disorders

- History of anorexia or bulimia

- Current hypertension uncontrolled by medication

- History of sensitivity to bupropion

- Pregnant or breastfeeding