Nicotine Replacement Therapy for Smoking Cessation in Schizophrenia

What Was Tested

This registered phase 4 trial tested Therapeutic nicotine (patch, non-peptide).

The registry classes the interventions as drug.

More on the Plan

Patients with schizophrenia also smoke more cigarettes on average per day (4) and attain higher serum levels of cotinine, the primary metabolite of nicotine, a finding attributed to deeper smoke inhalation (5).

Patients with schizophrenia clearly have greater morbidity and early mortality from 'natural causes' than people without schizophrenia (13-22) and are more likely to die prematurely from cardiovascular or pulmonary disease (14, 19, 23-26).

Smoking cessation outcomes in patients with schizophrenia using NRT have been extremely variable.

Twelve subjects completed the trial.

Who Took Part

Enrollment: 100 planned participants were the target.

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

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Women and men aged 18-70 with a diagnosis of schizophrenia or schizoaffective disorder (depressed type or bipolar type) by structured diagnostic interview or chart review. Expired air CO \> 9 ppm and self report of smoking \>1/2 pack per day of cigarettes. Willing to set a smoking quit date within one month of beginning treatment. Not treated with investigational medication in the past 30 days. Competent to provide informed consent or able to provide assent with legal guardian informed consent.

The full record lists 8 inclusion and 5 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; current use of topical medications.

How the Study Was Run

Design: randomized, parallel-group and double-blind.

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

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

Neither the participants nor the staff measuring them knew who was on Therapeutic nicotine (patch, non-peptide), so expectations could not easily colour the readings.

It started in 2001-07 with completion listed for 2005-12.

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 100 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.