Dissemination of a Tailored Tobacco Quitline for Rural Veteran Smokers

What Was Tested

This registered phase 3 trial tested Therapeutic nicotine (patch, non-peptide).

In addition, it will examine whether tailored treatment that is designed to address common comorbid conditions that are related to cigarette smoking enhances success with quitting relative to enhanced standard of care.

The investigators hypothesize that participants assigned to the tailored tobacco cessation intervention will report greater cessation rates at six months.

It had two arms (groups): Tailored intervention (experimental) and Enhanced standard of care (active comparator).

The registry classes the interventions as behavioral and drug.

Who Took Part

The registry lists 411 actual participants took part.

It was open to people of any sex aged from 18 years up to 99 years.

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

Examples of who could join: 18 + years of age. Smoke cigarettes on at least a daily basis. Receive primary care from the Iowa City VA Health Care System or an affiliated Community-based Outpatient Clinic (CBOC). Live in a non-metropolitan area (based on Rural-Urban Commuting Area Codes (RUCA) codes). Be willing to make an attempt to quit smoking in the next 30 days.

The full record lists 9 inclusion and 7 exclusion criteria; among the exclusions: planning to move within the next 12 months; presence of a terminal illness; unstable psychiatric disorder (e.g., acute psychosis).

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.

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

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.

Those kept unaware of assignments: investigator and outcomes assessor.

It started in 2013-07 with completion listed for 2018-01.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Tobacco use (time frame: Six-month follow-up).

It also tracked 5 secondary outcomes, for example Alcohol use, Depressive symptoms, Body weight, Physical Activity and Dietary intake.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Therapeutic nicotine (patch, non-peptide) in 411 people.

Its status is unknown; 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.