CompletedPhase 4

Safety and Effectiveness of Sustained Release Bupropion in Treating Individuals With Schizophrenia Who Smoke

United States51 participantsStarted 1998-08

Plain-language summary

Many individuals with schizophrenia smoke cigarettes. Individuals in the schizophrenic population often find it difficult to quit smoking. The purpose of this trial is to determine the safety and effectiveness of bupropion in treating individuals with schizophrenia who smoke.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Meets DSM-IV criteria for schizophrenia or schizoaffective disorder * Receiving a stable dose of antipsychotic medication for at least 1 month prior to study entry * Smokes at least 10 cigarettes per day * Wishes to stop smoking * Attended last three scheduled clinic visits, prior to study entry Exclusion Criteria: * Significant medical or neurologic illness * History of severe head injury with loss of consciousness * Treated with monoamine oxidase inhibitors or carbamazepine in the 14 days prior to study entry * Taking clozapine at doses greater than 500 mg/d without an anticonvulsant * Currently undergoing an acute exacerbation of psychotic symptoms * Current or history of bulimia or anorexia * Current excessive water intake * Recent history of mania * Known allergy or hypersensitivity to bupropion * Current substance abuse other than tobacco, nicotine replacement treatment, or smokeless tobacco * Currently receiving treatment with bupropion * Pregnant or breastfeeding

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

seven-day point prevalence of smoking reduction, defined as 50 % reduction in serum cotinine levels compared to baseline

Timeframe: end of treatment

Trial details

NCT IDNCT00307203

SponsorNational Institute on Drug Abuse (NIDA)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2004-02

View on ClinicalTrials.gov More Tobacco-Use Disorder trials

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.