Smoking Relapse Prevention in Schizophrenia

What Was Tested

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

It had three arms (groups): Bupropion + Nicotine patch + Nicotine gum or lozenges (other), Bupropion + Nicotine Patch (active comparator) and Placebo pill + placebo patch (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

Age-adjusted mortality from smoking-related diseases such as pulmonary and cardiovascular disease are two to six times higher among people with schizophrenia compared to age matched samples (24-27).

These findings were extended to patients with schizophrenia in a 12-week, randomized, double-blind trial of bupropion or placebo added to NRT + CBT (30).

It is their hypothesis that the 8-12 week treatment model that has been traditionally used for smoking cessation treatment is not of adequate duration for patients with schizophrenia.

Longer duration treatment can be justified in patients with schizophrenia for several reasons.

Who Took Part

The registry lists 25 actual participants took part.

It was open to people of any sex aged from 18 years up to 70 years.

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

Examples of who could join: Women and men aged 18-70 with DSM-IV diagnosis of schizophrenia or schizoaffective disorder by diagnostic interview and chart review. Expired air CO \> 10ppm and self report of smoking \>9 cigarettes per day. Willing to set a smoking quit date within 3 weeks of beginning treatment. Not treated with investigational medication in the past 30 days. Competent to provide informed consent or able to provide assent accompanying informed consent from legal guardian.

The full record lists 8 inclusion and 8 exclusion criteria; among the exclusions: patients who, in the investigator's opinion, pose a current severe homicide or suicide risk; subjects with a history of skin diseases (e.g. psoriasis), skin allergies, or strong reactions to topical preparations, medical dressings or tapes; history of multiple head injuries with neurological sequelae or a single severe head injury with lasting neurological sequelae.

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

The participants were allocated by chance, so the Therapeutic nicotine (patch, non-peptide) group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

As a double-blind Therapeutic nicotine (patch, non-peptide) study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2006-04 with completion listed for 2008-10.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Therapeutic nicotine (patch, non-peptide) in 25 people.

Its size is small, so on its own it can only give an early look.

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.