Effect of Bupropion on Smoking Behavior in Smokers With Schizophrenia

This study has been completed.
Sponsor:
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00218231
First received: September 16, 2005
Last updated: August 19, 2008
Last verified: August 2008
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Transdermal Nicotine and Bupropion-SR in Schizophrenics (Study 2)

Resource links provided by NLM:


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
Experimental: 1
300 mg/day bupropion-sr
Drug: 300 mg/day bupropion-sr
300 mg/day for 1 week
Other Name: zyban, wellbutrin
Placebo Comparator: 2
0 mg bupropion-sr
Drug: 0 mg/day bupropion-sr
0 mg/day bupropion-sr
Other Name: placebo

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
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: 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
Investigators
Principal Investigator: Jennifer W. Tidey Brown University
  More Information

No publications provided

Responsible Party: Jennifer W. Tidey, Brown University
ClinicalTrials.gov Identifier: NCT00218231     History of Changes
Other Study ID Numbers: NIDA-14002-2, R01-14002-2, 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):
schizophrenia
tobacco dependence
nicotine

Additional relevant MeSH terms:
Schizophrenia
Tobacco Use Disorder
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Bupropion
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 27, 2014