N-Acetyl Cysteine Plus Naltrexone in Methamphetamine Dependence

Forty subjects with DSM-IV methamphetamine dependence will receive 8 weeks of double-blind
combination medication (NAC plus naltrexone) or placebo. The hypothesis to be tested is that
NAC plus naltrexone will be effective and well tolerated in patients with methamphetamine
dependence compared to placebo. The proposed study will provide needed data on the treatment
of a public health crisis that currently lacks a clearly effective treatment.

Inclusion Criteria:

1. men and women age 18-65

2. current DSM-IV methamphetamine dependence.

Exclusion Criteria:

1. unstable medical illness

2. history of seizures

3. myocardial infarction within 6 months

4. current pregnancy or lactation, or inadequate contraception in women of childbearing
potential

5. any thoughts of suicide

6. lifetime history of DSM-IV bipolar disorder type I, dementia, or schizophrenia or any
other DSM-IV psychotic disorder

7. previous treatment with N-Acetyl Cysteine or naltrexone

8. treatment with investigational medication or depot neuroleptics within 3 months, with
fluoxetine within 6 weeks, or with other psychotropics within 2 weeks prior to study
baseline

9. abnormal liver function tests at screening

10. diagnosis of asthma

11. current use of opiates.