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

Sponsor:	National Institute on Drug Abuse (NIDA)
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00218231

Purpose

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.

Condition	Intervention	Phase
Schizophrenia Tobacco Use Disorder	Drug: 300 mg/day bupropion-sr Drug: 0 mg/day bupropion-sr	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study
Official Title:	Transdermal Nicotine and Bupropion-SR in Schizophrenics (Study 2)

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia Smoking

Drug Information available for: Bupropion hydrochloride Bupropion

U.S. FDA Resources

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

Primary Outcome Measures:

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

Secondary Outcome Measures:

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 ]

Enrollment:	48
Study Start Date:	January 2004
Study Completion Date:	August 2006
Primary Completion Date:	August 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 300 mg/day bupropion-sr	Drug: 300 mg/day bupropion-sr 300 mg/day for 1 week
2: Placebo Comparator 0 mg bupropion-sr	Drug: 0 mg/day bupropion-sr 0 mg/day bupropion-sr

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.

Eligibility

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

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00218231

Locations

United States, Rhode Island
Providence VA Medical Center, RI
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:	Brown University ( Jennifer W. Tidey )
Study ID Numbers:	NIDA-14002-2, R01-14002-2, DPMC
Study First Received:	September 16, 2005
Last Updated:	August 19, 2008
ClinicalTrials.gov Identifier:	NCT00218231 History of Changes
Health Authority:	United States: Federal Government

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

schizophrenia
tobacco dependence
nicotine

Additional relevant MeSH terms:

Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Tobacco Use Disorder
Physiological Effects of Drugs
Psychotropic Drugs
Disorders of Environmental Origin
Pharmacologic Actions
Schizophrenia

Mental Disorders
Therapeutic Uses
Bupropion
Substance-Related Disorders
Dopamine Agents
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Schizophrenia and Disorders with Psychotic Features
Antidepressive Agents

ClinicalTrials.gov processed this record on November 09, 2009