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)
Sponsor:
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00046813
First received: October 3, 2002
Last updated: August 19, 2008
Last verified: August 2008
  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 4

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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

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

Additional relevant MeSH terms:
Tobacco Use Disorder
Psychotic Disorders
Schizophrenia
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 18, 2014