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

This study has been terminated.

( Interim data analysis showed no effect between treatment groups )

First Received: October 3, 2002 Last Updated: August 19, 2008 History of Changes

Sponsored by:	National Institute on Drug Abuse (NIDA)
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00046813

Purpose

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

Condition	Intervention	Phase
Tobacco Use Disorder	Drug: Nicotine patch	Phase IV

MedlinePlus related topics: Schizophrenia

Drug Information available for: Nicotine tartrate Nicotine polacrilex

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Double-Blind, Placebo Control
Official Title:	High-Dose Versus Regular-Dose Nicotine Patch for Nicotine Dependence in Individuals With Schizophrenia or Schizoaffective Disorder

Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:

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

Estimated Enrollment:	100
Study Start Date:	August 2001
Study Completion Date:	April 2005
Primary Completion Date:	April 2005 (Final data collection date for primary outcome measure)

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

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00046813

Locations

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

Sponsors and Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

Principal Investigator:

Jill M. Williams, M.D.

University of Medicine and Dentistry New Jersey

More Information

No publications provided

Responsible Party:	UMDNJ-Robert Wood Johnson Medical School ( Jill Williams )
Study ID Numbers:	NIDA-14009-1, K23-14009-1
Study First Received:	October 3, 2002
Last Updated:	August 19, 2008
ClinicalTrials.gov Identifier:	NCT00046813 History of Changes
Health Authority:	United States: Federal Government

Study placed in the following topic categories:

Nicotine polacrilex
Neurotransmitter Agents
Tobacco Use Disorder
Nicotinic Agonists
Disorders of Environmental Origin
Central Nervous System Stimulants
Cholinergic Agents

Schizophrenia
Mental Disorders
Nicotine
Substance-Related Disorders
Psychotic Disorders
Peripheral Nervous System Agents
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:

Nicotine polacrilex
Neurotransmitter Agents
Disease
Molecular Mechanisms of Pharmacological Action
Cholinergic Agonists
Nicotinic Agonists
Tobacco Use Disorder
Physiological Effects of Drugs
Disorders of Environmental Origin
Central Nervous System Stimulants
Cholinergic Agents
Pharmacologic Actions

Schizophrenia
Pathologic Processes
Mental Disorders
Nicotine
Autonomic Agents
Therapeutic Uses
Substance-Related Disorders
Ganglionic Stimulants
Psychotic Disorders
Peripheral Nervous System Agents
Central Nervous System Agents
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on May 06, 2009