Effect of Bupropion on Smoking Behavior in People With Schizophrenia Who Smoke

Condition(s) targeted: Schizophrenia

Intervention: Tobacco Use Disorder (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: National Institute on Drug Abuse (NIDA)

Official(s) and/or principal investigator(s):
Jennifer W. Tidey, Principal Investigator, Affiliation: Brown University

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

Official title: Effects of Bupropion-SR on Smoking in People With Schizophrenia

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study

Primary outcome:

Withdrawal severity

Stimulated and non-stimulated craving

Smoking behavior

Secondary outcome: Adverse events

Detailed description: There is a high prevalence of cigarette smoking among people with schizophrenia; however, few smoking cessation interventions have been developed for these individuals. Bupropion is an antidepressant medication commonly used to treat smoking. Because of neurochemical dysfunction associated with schizophrenia, pharmacotherapies such as bupropion may be effective in smokers with schizophrenia. The purpose of this trial is to evaluate the effects of bupropion on smoking urges and smoking behavior in individuals with schizophrenia who smoke.

This trial will last 2 years. Participants will be randomly assigned to receive either bupropion or placebo. Study visits will occur during treatment once per week for 4 weeks. Assessments of smoking behavior, nicotine withdrawal symptoms, and smoking self-reports will be completed at all study visits. The medical screening session will assess a potential participant's medical history, smoking history, psychiatric diagnosis, psychiatric symptoms, and nicotine dependence. It will also include a visit with the study physician and a urine screen to detect the presence of illicit drugs and/or pregnancy. During study visits, participant's physiological responses to smoking cue reactivity will be measured as well as their urge to smoke, nicotine withdrawal symptoms, and psychiatric symptoms. Pre- and post-session breath carbon dioxide levels, smoking behavior, and medication compliance will also be recorded.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Providence VA Medical Center, RI, Providence, Rhode Island 02908, United States; Recruiting
Amy B. Adolfo, BS, Phone: 401-273-7100, Ext: 3871, Email: amy_scallon@brown.edu

Brown University, Providence, Rhode Island 02912, United States; Recruiting
Jennifer W. Tidey, Phone: 401-444-1840, Email: jennifer-tidey@brown.edu

Starting date: January 2004
Last updated: February 24, 2006