Nicotine Patch for Nicotine Dependence in Individuals With Schizophrenia or Schizoaffective Disorder - 1

This is a randomized double-blind placebo controlled 8 week outpatient medication clinical
trial to evaluate the relative efficacy of High-Dose (42mg) versus Regular Dose (21mg)
nicotine patch treatment for individuals with schizophrenia or schizoaffective disorder and
nicotine dependence. It also has a placebo controlled continuation phase to examine if
longer duration of treatment is more effective than a standard eight week dosing schedule.
The literature supports that schizophrenics have an increased rates of smoking and are more
likely to be dependent on nicotine. Nicotine gum and patches are safe and now approved for
over the counter sale in the United States. High dose patch therapy is well tolerated and
provides more complete nicotine replacement. This improves withdrawal symptom relief and it
is hypothesized that abstinence rates from smoking will be greater in the high dose patch
group. Few trials have examined the usefulness of nicotine replacement therapy in this
population and preliminary evidence shows lower than expected success rates of smoking
cessation with conventional treatments

Inclusion Criteria:

Subjects: 100 stable outpatients with schizophrenia and schizoaffective disorder and
nicotine dependence. All subjects will meet the following inclusion criteria:

- Patients who are able to provide informed consent

- Patients will meet DSM-IV diagnostic criteria for Nicotine Dependence and
Schizophrenia or Schizoaffective disorder

- Patients will be stable on their current antipsychotic regimen and will be interested
in treatment for both their psychiatric and nicotine dependence

Exclusion Criteria:

- Potential subjects meeting the following criteria will be excluded:

- Patients with history of clinically significant angina or unstable angina pectoris

- Patients with severe CAD or recent myocardial infarction (within last 6 months)

- Patients with evidence or history of other severe medical illness (hematologic, renal
or neoplastic)

- Patients who represent a serious suicide risk, including recent suicidal behavior or
attempt within the last thirty days

- Patients with history of severe skin allergies or chronic dermatoses

- Concomitant use of clonidine or bupropion

- Pregnant females