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

Condition	Treatment or Intervention	Phase
Tobacco Use Disorder	Drug: Nicotrol	Phase IV

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

Ages Eligible for Study:  18 Years   -   70 Years,  Genders Eligible for Study:  Both

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

Jill M. Williams, M.D.      (732)235-4097    jill.williams@umdnj.edu

New Jersey
      UMDNJ - Robert Wood Johnson Medical School, Piscataway,  New Jersey,  08854,  United States; Recruiting

Study chairs or principal investigators

Jill M. Williams, M.D.,  Principal Investigator,  UMDNJ - Robert Wood Johnson Medical School   

Study ID Numbers:  NIDA-14009-1; K23-14009-1
Record last reviewed:  August 2001
Record first received:  October 3, 2002
ClinicalTrials.gov Identifier:  NCT00046813
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2004-11-08