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| Sponsor: | 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 |
| 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 |
| 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) |
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 |
Inclusion Criteria:
Subjects: 100 stable outpatients with schizophrenia and schizoaffective disorder and nicotine dependence. All subjects will meet the following inclusion criteria:
Exclusion Criteria:
Contacts and 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 | |
| Principal Investigator: | Jill M. Williams, M.D. | University of Medicine and Dentistry New Jersey |
More Information
| 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 |
|
Tobacco Use Disorder Psychotic Disorders Schizophrenia Substance-Related Disorders Mental Disorders Schizophrenia and Disorders with Psychotic Features Nicotine Nicotine polacrilex 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 Central Nervous System Stimulants Central Nervous System Agents Therapeutic Uses |