Tobacco Use Disorder
Conditions
Brief 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
Detailed description
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
Interventions
DRUGNicotine patch
Sponsors
National Institute on Drug Abuse (NIDA)
Study design
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| continuous abstinence from smoking | 8 weeks |
Countries
United States
Outcome results
None listed