Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00046813
Status:
TERMINATED
Last Update Posted:
2017-01-12
First Post:
2002-10-03
Brief Title:
Nicotine Patch for Nicotine Dependence in Individuals With Schizophrenia or Schizoaffective Disorder - 1
Sponsor:
National Institute on Drug Abuse NIDA
Organization:
National Institute on Drug Abuse NIDA
Study Overview
Official Title:
High-Dose Versus Regular-Dose Nicotine Patch for Nicotine Dependence in Individuals With Schizophrenia or Schizoaffective Disorder
Status:
TERMINATED
Status Verified Date:
2008-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Interim data analysis showed no effect between treatment groups
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| K23-14009-1 | None | None | None |