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

What Was Tested

In this phase 4 trial, researchers set out to test Therapeutic nicotine (patch, non-peptide).

Many individuals with schizophrenia smoke cigarettes.

Individuals in the schizophrenic population often find it difficult to quit smoking.

It had two arms (groups): I (experimental) and II (placebo comparator).

Placebo group received placebo, in addition to weekly CBT and nicotine replacement therapy.

The registry classes the interventions as behavioral and drug.

More on the Plan

This trial will last 12 weeks.

Participants will be randomly assigned to receive SR bupropion or placebo.

All participants will receive weekly CBT.

Participants will be followed for 3 months following completion of the 12-week treatment session.

Who Took Part

Enrollment: 51 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Meets DSM-IV criteria for schizophrenia or schizoaffective disorder. Smokes at least 10 cigarettes per day. Wishes to stop smoking. Attended last three scheduled clinic visits, prior to study entry.

The full record lists 5 inclusion and 12 exclusion criteria; among the exclusions: history of severe head injury with loss of consciousness; treated with monoamine oxidase inhibitors or carbamazepine in the 14 days prior to study entry; currently undergoing an acute exacerbation of psychotic symptoms.

How the Study Was Run

The set-up was randomized, parallel-group and triple-blind.

Because people in this Therapeutic nicotine (patch, non-peptide) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Therapeutic nicotine (patch, non-peptide) group and the comparison group ran side by side rather than switching.

Blinding on both sides kept the participants and researchers unaware of who received Therapeutic nicotine (patch, non-peptide).

Those kept unaware of assignments: participant, care provider and investigator.

It started in 1998-08 with completion listed for 2004-02.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 8 secondary outcomes, for example continuous tobacco abstinence (weekly expired CO measurements less than 9 ppm and self report), psychotic symptoms, negative side effects, negative and depressive symptoms compared to baseline at the end of the 3-month treatment and 3-month follow-up phases, measures of attention and memory while attempting to quit smoking and health-related quality at the end of the 3-month treatment and 3-month follow-up phases.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Therapeutic nicotine (patch, non-peptide) in 51 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Therapeutic nicotine (patch, non-peptide) compound page, all human trials.