Varenicline for Smoking Cessation in Hospitalized Patients With Psychiatric Disorders

What Was Tested

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

It had two arms (groups): Varenicline (experimental) and Nicotine patch (active comparator).

The registry classes the interventions as drug.

More on the Plan

Safety of varenicline in this population has also been stated as adverse events are similar to other smoking cessation medications.

Regarding safety, inpatient wards are probably the best setting to test safety as any adverse effect can be reported immediately and in case of an intervention needed, this can be provided at once.

This study will have three phases: screening phase (1), treatment phase (2a and 2b), and non-treatment phase (3). 1.

Screening phase: Psychiatrists and psychologists will be responsible for informing to potential participants about the study, and check eligibility for each patient.

Who Took Part

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

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

Examples of who could join: Age 18 to 65 years old, inclusive. Good understanding of protocol to informed consent. Having at least a psychiatric disorder according to DSM-5. Living in Barcelona city or in the metropolitan area. Not being at high risk of self-injury or suicidal behavior, in the opinion of the Investigator.

The full record lists 10 inclusion and 8 exclusion criteria; among the exclusions: history of suicide attempt in the previous year; not agree to abstain from cannabis; taking bupropion.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

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.

Everyone knew when Therapeutic nicotine (patch, non-peptide) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2019-01 with completion listed for 2020-04.

It ran at 4 sites in Spain (4).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Assessment of safety: incidence of emergent "severe" neuropsychiatric event (time frame: Randomization day). Assessment of safety: incidence of emergent "severe" neuropsychiatric event (time frame: Week 1). Assessment of safety: incidence of emergent "severe" neuropsychiatric event (time frame: Week 2).

What This Means in Plain Language

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

It was withdrawn before enrolling anyone; 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.