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OpenTrials
Completed

NCT Number: NCT00218218

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Brown University, Providence, Rhode Island, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transdermal Nicotine Patch

Drug

42 mg transdermal nicotine

Other names: nicotine patch

21 mg transdermal nicotine

Drug

Other names: nicotine patch

Placebo Patch

Drug

Primary outcomes

  1. Smoking behavior (measured by automated topography)

    Time frame: after 5 hrs abstinence

Secondary outcomes

  1. Adverse events (measured by self-report throughout the study)

    Time frame: ongoing

  2. Nicotine withdrawal severity

    Time frame: after 5 hrs abstinence

  3. Smoking urge

    Time frame: after 5 hrs withdrawal

Sponsors and collaborators

Lead sponsor

National Institute on Drug Abuse (NIDA)

Nih

Registry information

Official study title

Transdermal Nicotine and Bupropion for Smoking in Schizophrenics (Study 1)

Important dates

Study start
2002
Primary completion
2005
Study completion
2005
First posted
Sep 22, 2005
Registry last updated
Jan 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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