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High-Dose versus Regular-Dose Nicotine Patch for Nicotine Dependence in Individuals with Schizophrenia or Schizoaffective Disorder - 1



High-Dose versus Regular-Dose Nicotine Patch for Nicotine Dependence in Individuals with Schizophrenia or Schizoaffective Disorder - 1

For Condition: Tobacco Use Disorder
Status: Recruiting
Sponsor(s): National Institute on Drug Abuse (NIDA) ,
Synopsis: High Dose versus Regular Dose Nicotine Patch for Nicotine Dependence in Individuals with Schizophrenia or Schizoaffective disorder
Details: 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
Eligibility:
Study Type:  Interventional, Treatment, Double-Blind, Placebo Control
Minimum Age/Maximum Age: 18 Years/70 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: Subjects: 100 stable outpatients with schizophrenia and schizoaffective disorder and nicotine dependence. All subjects will meet the following inclusion criteria: - Male and female patients between 18-70 years old 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
Total Enrollment: 100

Location and Contact Information:

Overall Study Official:
JillWilliams,  Principal Investigator,  UMDNJ - Robert Wood Johnson Medical School

UMDNJ - Robert Wood Johnson Medical School *Recruiting*
Piscataway,  New Jersey,  08854
United States
Recruiting Jill  Williams 732-235-4097


Additional Information:
Study ID Numbers:  NIDA-14009-1;  K23-14009-1
Study Start Date: August 2001
Record last reviewed: August 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00046813

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3. Progesterone Treatment in Female Smokers - 12

4. Chemical Dependency and Smoking Cessation: Patient's Views - 1

5. Incentive Programs for Female Substance Abusers Who Smoke - 3

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