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

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

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

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• 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

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	8 weeks

Collaborators and Investigators

• 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

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): October 3, 2002

Study Record Updates

• Last Update Posted (Estimate): January 12, 2017
• Last Update Submitted That Met QC Criteria: January 11, 2017
• Last Verified: August 1, 2008

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Psychotic Disorders; Tobacco Use Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: NIDA-14009-1; K23-14009-1