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

Tobacco Use Disorder Clinical Trial

Official title:

High-Dose Versus Regular-Dose Nicotine Patch for Nicotine Dependence in Individuals With Schizophrenia or Schizoaffective Disorder

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00046813
• Other study ID #: NIDA-14009-1
• Secondary ID: K23-14009-1
• Status: Terminated
• Phase: Phase 4
• First received: October 3, 2002
• Last updated: January 11, 2017
• Start date: August 2001
• Est. completion date: April 2005

Study information

• Verified date: August 2008
• Source: National Institute on Drug Abuse (NIDA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 100
• Est. completion date: April 2005
• Est. primary completion date: April 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Disease
• Psychotic Disorders
• Schizophrenia
• Tobacco Use Disorder

Intervention

Drug:
• Nicotine patch

Locations

Country	Name	City	State
United States	UMDNJ - Robert Wood Johnson Medical School	Piscataway	New Jersey
United States	UMDNJ - Robert Wood Johnson Medical School-2	Piscataway	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	continuous abstinence from smoking		8 weeks	No