Overview

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

Status:
Terminated
Trial end date:
2005-04-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to test the use of High-Dose versus Regular-Dose Nicotine Patch for Nicotine Dependence in Individuals with Schizophrenia or Schizoaffective Disorder
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
National Institute on Drug Abuse (NIDA)
Treatments:
Nicotine
Criteria
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