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

This study has been completed.
Sponsor:
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00218218
First received: September 16, 2005
Last updated: August 19, 2008
Last verified: August 2008
  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 2

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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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 July 20, 2014