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

Phase 2

Completed

• Conditions: Schizophrenia and Disorders With Psychotic Features; Tobacco Use Disorder; Schizophrenia
• Interventions: Drug: placebo patch; Drug: Transdermal Nicotine Patch; Drug: 21 mg transdermal nicotine

• Registration Number: NCT00218218
• Lead Sponsor: National Institute on Drug Abuse (NIDA)

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.

Study Timeline

• Study Start: 2002-06
• Primary Completion: 2005-02
• Study Completion: 2005-02
• Study First Submitted: 2005-09-16
• Study First Submitted QC: 2005-09-16
• Study First Posted: 2005-09-22
• Status Verified: 2008-08
• Last Update Submitted: 2017-01-11
• Last Update Posted: 2017-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
3	placebo patch	placebo patch
1	Transdermal Nicotine Patch	Transdermal nicotine, 42 mg
2	21 mg transdermal nicotine	Transdermal nicotine, 21 mg

Primary Outcome Measures

Name	Time	Method
Smoking behavior (measured by automated topography)	after 5 hrs abstinence

Secondary Outcome Measures

Name	Time	Method
Nicotine withdrawal severity	after 5 hrs abstinence
Smoking urge	after 5 hrs withdrawal
Adverse events (measured by self-report throughout the study)	ongoing

Trial Locations

Locations (2)

Providence VA Medical Center; 🇺🇸 Providence, Rhode Island, United States

Brown University; 🇺🇸 Providence, Rhode Island, United States