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

January 11, 2017 updated by: National Institute on Drug Abuse (NIDA)

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

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

Study Overview

Status

Terminated

Conditions

Tobacco Use Disorder

Intervention / Treatment

Drug: Nicotine patch

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 Type

Interventional

Enrollment

100

Phase

Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- New Jersey
  - Piscataway, New Jersey, United States, 08854
    - UMDNJ - Robert Wood Johnson Medical School
  - Piscataway, New Jersey, United States, 08854
    - UMDNJ - Robert Wood Johnson Medical School-2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
continuous abstinence from smoking Time Frame: 8 weeks	8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute on Drug Abuse (NIDA)

Investigators

Principal Investigator: Jill M. Williams, M.D., Rutgers, The State University of New Jersey

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2001

Primary Completion (Actual)

April 1, 2005

Study Completion (Actual)

April 1, 2005

Study Registration Dates

First Submitted

October 3, 2002

First Submitted That Met QC Criteria

October 2, 2002

First Posted (Estimate)