Tailored Tobacco Quitline for Rural Veterans

What Was Tested

The trial (phase 2) is built around Therapeutic nicotine (patch, non-peptide).

Study the feasibility of an individually-tailored telephone intervention for rural smokers. 2.

Examine the impact of the intervention on tobacco use outcomes. 3.

It had two arms (groups): Tailored Intervention Group (experimental) and Enhanced Standard of Care Group (active comparator).

The registry classes the interventions as behavioral and drug.

More on the Plan

Results from epidemiologic studies indicate that tobacco use is especially elevated among those living in rural areas.

Smokers frequently experience conditions and concerns that adversely impact their ability to quit smoking.

Concern about gaining weight, a common consequence of quitting smoking, is also frequently cited by smokers as an important barrier to quitting.

In an effort to address these barriers, the current study will evaluate a telephone intervention for tobacco use that also addresses issues related to risky alcohol use, depressed mood, and postcessation weight gain based on each individual smoker's needs.

Who Took Part

The registry lists 63 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: Being a veteran. 18 + years of age. Smoke cigarettes on at least a daily basis. Receive primary care from the Iowa City VAMC or Coralville Clinic. Live in a non-metropolitan area (based on RUCA codes).

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

The set-up was randomized, parallel-group and double-blind.

Because people in this Therapeutic nicotine (patch, non-peptide) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

Blinding on both sides kept the participants and researchers unaware of who received Therapeutic nicotine (patch, non-peptide).

Those kept unaware of assignments: investigator and outcomes assessor.

It started in 2012-06 with completion listed for 2013-06.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Treatment Satisfaction (time frame: End of treatment (seven weeks after baseline)).

It also tracked 7 secondary outcomes, for example Number of Participants Abstinent From Tobacco Use, Alcohol Use, Depressive Symptoms, Body Weight, Enrollment Rate and Retention.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Therapeutic nicotine (patch, non-peptide) in 63 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Therapeutic nicotine (patch, non-peptide) compound page, all human trials.