Study Stopped
Interim data analysis showed no effect between treatment groups
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
2 other identifiers
interventional
100
1 country
2
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Aug 2001
Longer than P75 for phase_4
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2001
CompletedFirst Submitted
Initial submission to the registry
October 3, 2002
CompletedFirst Posted
Study publicly available on registry
October 3, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2005
CompletedJanuary 12, 2017
August 1, 2008
3.7 years
October 3, 2002
January 11, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
continuous abstinence from smoking
8 weeks
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
UMDNJ - Robert Wood Johnson Medical School-2
Piscataway, New Jersey, 08854, United States
UMDNJ - Robert Wood Johnson Medical School
Piscataway, New Jersey, 08854, United States
Related Publications (1)
Theodoulou A, Chepkin SC, Ye W, Fanshawe TR, Bullen C, Hartmann-Boyce J, Livingstone-Banks J, Hajizadeh A, Lindson N. Different doses, durations and modes of delivery of nicotine replacement therapy for smoking cessation. Cochrane Database Syst Rev. 2023 Jun 19;6(6):CD013308. doi: 10.1002/14651858.CD013308.pub2.
PMID: 37335995DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jill M. Williams, M.D.
Rutgers, The State University of New Jersey
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Sponsor Type
- NIH
Study Record Dates
First Submitted
October 3, 2002
First Posted
October 3, 2002
Study Start
August 1, 2001
Primary Completion
April 1, 2005
Study Completion
April 1, 2005
Last Updated
January 12, 2017
Record last verified: 2008-08