Nicotine Patch for Nicotine Dependence in Individuals With Schizophrenia or Schizoaffective Disorder - 1

NCT ID: NCT00046813

Last Updated: 2017-01-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-08-31
• Study Completion Date: 2005-04-30

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

Conditions

Tobacco Use Disorder

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Nicotine patch

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: lead

Responsible Party

UMDNJ-Robert Wood Johnson Medical School

Principal Investigators

Jill M. Williams, M.D.

Role: PRINCIPAL_INVESTIGATOR

Rutgers, The State University of New Jersey

Locations

UMDNJ - Robert Wood Johnson Medical School-2

Piscataway, New Jersey, United States

UMDNJ - Robert Wood Johnson Medical School

Piscataway, New Jersey, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 37335995 (View on PubMed)

Other Identifiers

K23-14009-1

Identifier Type: -

Identifier Source: secondary_id

NIDA-14009-1

Identifier Type: -

Identifier Source: org_study_id