Effects of Transdermal Nicotine on Smoking, Craving and Withdrawal in People With Schizophrenia - Full Text View

Sponsor:	National Institute on Drug Abuse (NIDA)
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00218218

Purpose

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.

Condition	Intervention	Phase
Schizophrenia and Disorders With Psychotic Features Tobacco Use Disorder Schizophrenia	Drug: Transdermal Nicotine Patch Drug: 21 mg transdermal nicotine Drug: placebo patch	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Basic Science
Official Title:	Transdermal Nicotine and Bupropion for Smoking in Schizophrenics (Study 1)

Resource links provided by NLM:

MedlinePlus related topics: Mental Disorders Psychotic Disorders Schizophrenia Smoking

Drug Information available for: Nicotine tartrate Nicotine polacrilex

U.S. FDA Resources

Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:

Smoking behavior (measured by automated topography) [ Time Frame: after 5 hrs abstinence ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Adverse events (measured by self-report throughout the study) [ Time Frame: ongoing ] [ Designated as safety issue: Yes ]
Nicotine withdrawal severity [ Time Frame: after 5 hrs abstinence ] [ Designated as safety issue: No ]
Smoking urge [ Time Frame: after 5 hrs withdrawal ] [ Designated as safety issue: No ]

Enrollment:	48
Study Start Date:	June 2002
Study Completion Date:	February 2005
Primary Completion Date:	February 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Transdermal nicotine, 42 mg	Drug: Transdermal Nicotine Patch 42 mg transdermal nicotine Other Name: nicotine patch
Experimental: 2 Transdermal nicotine, 21 mg	Drug: 21 mg transdermal nicotine Other Name: nicotine patch
Placebo Comparator: 3 placebo patch	Drug: placebo patch

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.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00218218

Locations

United States, Rhode Island
Providence VA Medical Center
Providence, Rhode Island, United States, 02908
Brown University
Providence, Rhode Island, United States, 02912

Sponsors and Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

Principal Investigator:

Jennifer W. Tidey

Brown University

More Information

No publications provided

Responsible Party:	Jennifer W. Tidey, Brown University
ClinicalTrials.gov Identifier:	NCT00218218 History of Changes
Other Study ID Numbers:	NIDA-14002-1, R01-14002-1, DPMC
Study First Received:	September 16, 2005
Last Updated:	August 19, 2008
Health Authority:	United States: Federal Government

Keywords provided by National Institute on Drug Abuse (NIDA):

Nicotine Dependence
Tobacco Dependence

Additional relevant MeSH terms:

Mental Disorders
Psychotic Disorders
Schizophrenia
Tobacco Use Disorder
Schizophrenia and Disorders with Psychotic Features
Substance-Related Disorders
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

ClinicalTrials.gov processed this record on February 09, 2012