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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

October 3, 2002

Last Updated Date

August 19, 2008

Start Date ^†

August 2001

Current Primary Outcome Measures ^†

continuous abstinence from smoking [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00046813 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Original Secondary Outcome Measures ^†

Descriptive Information

Brief Title ^†

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

Official Title ^†

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

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

Study Phase

Phase IV

Study Type ^†

Interventional

Study Design ^†

Treatment, Double-Blind, Placebo Control

Condition ^†

Tobacco Use Disorder

Intervention ^†

Drug: Nicotine patch

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Terminated

Enrollment ^†

100

Completion Date

April 2005

Primary Completion Date

April 2005 (final data collection date for primary outcome measure)

Eligibility 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

Gender

Both

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00046813

Responsible Party

Jill Williams, UMDNJ-Robert Wood Johnson Medical School

Secondary IDs ^††

K23-14009-1

Study Sponsor ^†

National Institute on Drug Abuse (NIDA)

Collaborators ^††

Investigators ^†

Principal Investigator:

Jill M. Williams, M.D.

University of Medicine and Dentistry New Jersey

Information Provided By

National Institute on Drug Abuse (NIDA)

Verification Date

August 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.