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Effects of Transdermal Nicotine on Smoking, Craving and Withdrawal in People With Schizophrenia

Primary Purpose

Schizophrenia and Disorders With Psychotic Features, Tobacco Use Disorder, Schizophrenia

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Transdermal Nicotine Patch
21 mg transdermal nicotine
placebo patch
Sponsored by
National Institute on Drug Abuse (NIDA)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Schizophrenia and Disorders With Psychotic Features focused on measuring Nicotine Dependence, Tobacco Dependence

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Smokes between 20 and 50 cigarettes per day Diagnosis of schizophrenia or schizoaffective disorder Exclusion Criteria: If enrolled in the control group, must not be diagnosed with a psychiatric disorder Currently dependent on alcohol or any drug (other than nicotine) Currently trying to quit smoking Currently taking bupropion, desipramine, clonidine, buspirone, or doxepin History of liver disease History of heart attacks or chest pain Allergic to adhesives Pregnant or breastfeeding

Sites / Locations

  • Providence VA Medical Center
  • Brown University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

1

2

3

Arm Description

Transdermal nicotine, 42 mg

Transdermal nicotine, 21 mg

placebo patch

Outcomes

Primary Outcome Measures

Smoking behavior (measured by automated topography)

Secondary Outcome Measures

Adverse events (measured by self-report throughout the study)
Nicotine withdrawal severity
Smoking urge

Full Information

First Posted
September 16, 2005
Last Updated
January 11, 2017
Sponsor
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT00218218
Brief Title
Effects of Transdermal Nicotine on Smoking, Craving and Withdrawal in People With Schizophrenia
Official Title
Transdermal Nicotine and Bupropion for Smoking in Schizophrenics (Study 1)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2008
Overall Recruitment Status
Completed
Study Start Date
June 2002 (undefined)
Primary Completion Date
February 2005 (Actual)
Study Completion Date
February 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Individuals with schizophrenia are three times as likely to smoke cigarettes as individuals without schizophrenia. While a great deal of research has been focused on smoking cessation programs for healthy individuals, little attention has been directed towards developing an effective smoking cessation treatment for schizophrenics. This project will evaluate the effects of 0, 21 and 42 mg transdermal nicotine on smoking, urge to smoke, and nicotine withdrawal symptoms after 5 hrs abstinence in smokers with schizophrenia and heavy-smoking non-psychiatric control smokers.
Detailed Description
Nicotine is the most commonly abused drug among individuals with schizophrenia; at least 60 percent of schizophrenics smoke cigarettes. Nicotine withdrawal may cause a temporary worsening of schizophrenia symptoms, making it especially difficult for these individuals to quit smoking. Little research has been done on the most effective way to control nicotine use in schizophrenic individuals. Transdermal nicotine and bupropion reduce smoking in non-psychiatric smokers, but little is known about the effects of these medications in smokers with schizophrenia. This project examines the effects of 0, 21 and 42 mg transdermal nicotine on smoking behavior and related subjective effects (urge to smoke and nicotine withdrawal symptoms) in smokers with schizophrenia and non-psychiatric heavy smoking controls. Participants come to the laboratory at 9 am, at which time placebo or nicotine patches are applied. After 5 hrs of smoking abstinence, participants undergo a smoking cue reactivity assessment in which craving and withdrawal symptoms are measured after viewing and handling neutral cues and smoking cues. This is followed by 90 min period in which participants can smoke freely, and smoking topography variables are measured.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia and Disorders With Psychotic Features, Tobacco Use Disorder, Schizophrenia
Keywords
Nicotine Dependence, Tobacco Dependence

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Transdermal nicotine, 42 mg
Arm Title
2
Arm Type
Experimental
Arm Description
Transdermal nicotine, 21 mg
Arm Title
3
Arm Type
Placebo Comparator
Arm Description
placebo patch
Intervention Type
Drug
Intervention Name(s)
Transdermal Nicotine Patch
Other Intervention Name(s)
nicotine patch
Intervention Description
42 mg transdermal nicotine
Intervention Type
Drug
Intervention Name(s)
21 mg transdermal nicotine
Other Intervention Name(s)
nicotine patch
Intervention Type
Drug
Intervention Name(s)
placebo patch
Primary Outcome Measure Information:
Title
Smoking behavior (measured by automated topography)
Time Frame
after 5 hrs abstinence
Secondary Outcome Measure Information:
Title
Adverse events (measured by self-report throughout the study)
Time Frame
ongoing
Title
Nicotine withdrawal severity
Time Frame
after 5 hrs abstinence
Title
Smoking urge
Time Frame
after 5 hrs withdrawal

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Smokes between 20 and 50 cigarettes per day Diagnosis of schizophrenia or schizoaffective disorder Exclusion Criteria: If enrolled in the control group, must not be diagnosed with a psychiatric disorder Currently dependent on alcohol or any drug (other than nicotine) Currently trying to quit smoking Currently taking bupropion, desipramine, clonidine, buspirone, or doxepin History of liver disease History of heart attacks or chest pain Allergic to adhesives Pregnant or breastfeeding
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer W. Tidey
Organizational Affiliation
Brown University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Providence VA Medical Center
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02908
Country
United States
Facility Name
Brown University
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02912
Country
United States

12. IPD Sharing Statement

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Effects of Transdermal Nicotine on Smoking, Craving and Withdrawal in People With Schizophrenia

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