Effect of Bupropion on Smoking Behavior in Smokers With Schizophrenia - Tabular View

Tracking Information

First Received Date ^ICMJE

September 16, 2005

Last Updated Date

August 19, 2008

Start Date ^ICMJE

January 2004

Primary Completion Date

August 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Smoking behavior [ Time Frame: after 5 hrs abstinence ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Smoking behavior
Withdrawal severity
Stimulated and non-stimulated craving

Change History

Complete list of historical versions of study NCT00218231 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Adverse events [ Time Frame: ongoing ] [ Designated as safety issue: Yes ]
urge to smoke [ Time Frame: after 5 hrs abstinence ] [ Designated as safety issue: No ]
nicotine withdrawal symptoms [ Time Frame: after 5 hrs withdrawal ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Adverse events

Descriptive Information

Brief Title ^ICMJE

Effect of Bupropion on Smoking Behavior in Smokers With Schizophrenia

Official Title ^ICMJE

Transdermal Nicotine and Bupropion-SR in Schizophrenics (Study 2)

Brief Summary

Many individuals with schizophrenia smoke cigarettes but little is known about the factors that control smoking in people with schizophrenia. The purpose of this trial is to evaluate how bupropion, an antidepressant medication, affects smoking behaviors in individuals with schizophrenia who smoke.

Detailed Description

There is a high prevalence of cigarette smoking among people with schizophrenia and few smoking cessation interventions have been developed for these individuals. Bupropion is an antidepressant medication commonly used to treat smoking in smokers without psychiatric disorder. This study compares how smokers with schizophrenia and smokers without psychiatric illness respond to bupropion (0, 300 mg/day).

Participants will be randomly assigned to receive either bupropion or placebo. Study visits will occur after one-week treatment with placebo or bupropion. During study sessions, participants will come to the laboratory at 9 am and will remain abstinent in the laboratory for 5 hrs. Participants will then be assessed for craving and withdrawal symptoms after viewing and handling neutral cues and smoking cues. After that, participants will have a 90-min period to smoke, and smoking topography will be measured.

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study

Condition ^ICMJE

Schizophrenia
Tobacco Use Disorder

Intervention ^ICMJE

Drug: 300 mg/day bupropion-sr
Drug: 0 mg/day bupropion-sr

Study Arms / Comparison Groups

Experimental: 300 mg/day bupropion-sr
Placebo Comparator: 0 mg bupropion-sr

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

August 2006

Primary Completion Date

August 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Diagnosed with schizophrenia or schizo-affective disorder
Smokes between 20 and 50 cigarettes per day
Moderate to high nicotine dependence score
Interest in quitting smoking

Exclusion Criteria:

Currently trying to quit smoking
Seizure disorder or lowered seizure threshold due to anorexia, bulimia, head trauma, diabetes with insulin, or hypoglycemics
Alcohol or drug use disorders
Requires certain medications
Pregnant or breastfeeding

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00218231

Responsible Party

Jennifer W. Tidey, Brown University

Study ID Numbers ^ICMJE

NIDA-14002-2, R01-14002-2, DPMC

Study Sponsor ^ICMJE

National Institute on Drug Abuse (NIDA)

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Jennifer W. Tidey

Brown University

Information Provided By

National Institute on Drug Abuse (NIDA)

Verification Date

August 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP