Nicotine Patch for Nicotine Dependence in Individuals With Schizophrenia or Schizoaffective Disorder - 1

Plain-language guide to NCT00046813: phase 4 interventional trial of Therapeutic nicotine (patch, non-peptide), 100 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT00046813
Phase: phase 4
Status: terminated early
Start: 2001-08
Completion (planned or actual): 2005-04
Participants: 100
Design: double-blind, treatment
Conditions studied: Tobacco Use Disorder
Results posted: not yet

What This Study Did, in Plain Language

What Was Tested

The trial (phase 4) is built around Therapeutic nicotine (patch, non-peptide).

The registry classes the interventions as drug.

More on the Plan

Few trials have examined the usefulness of nicotine replacement therapy in this population and preliminary evidence shows lower than expected success rates of smoking cessation with conventional treatments.

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: Patients who are able to provide informed consent. Patients will meet DSM-IV diagnostic criteria for Nicotine Dependence and Schizophrenia or Schizoaffective disorder. Patients will be stable on their current antipsychotic regimen and will be interested in treatment for both their psychiatric and nicotine dependence.

The full record lists 3 inclusion and 8 exclusion criteria; among the exclusions: potential subjects meeting the following criteria will be excluded:; patients with severe cad or recent myocardial infarction (within last 6 months); patients with evidence or history of other severe medical illness (hematologic, renal or neoplastic).

How the Study Was Run

The set-up was double-blind.

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

It started in 2001-08 with completion listed for 2005-04.

It ran at 2 sites in United States (2).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: continuous abstinence from smoking (time frame: 8 weeks).

What This Means in Plain Language

Put simply, this is a phase 4 trial of Therapeutic nicotine (patch, non-peptide) in 100 people.

It ended early (terminated); 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.

Our Notes on the Compound

Therapeutic nicotine (patch, non-peptide): Pure nicotine as a signaling tool, separated from smoking and vaping.

Therapeutic nicotine (patch, non-peptide) in the library

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.