Varenicline or Nicotine Patch in Promoting Smoking Cessation Among Current Smokers

What Was Tested

The trial (not phased) is built around Therapeutic nicotine (patch, non-peptide).

This pilot clinical trial studies varenicline or nicotine patch in promoting smoking cessation among current smokers.

Varenicline or nicotine patch may help people stop smoking.

It had two arms (groups): Arm I (varenicline) (experimental) and Arm II (nicotine patch) (active comparator).

Patients undergo general smoking cessation counseling and receive varenicline PO QD on days 1-28. Courses repeat every 28 days for up to 12 weeks.

Patients undergo general smoking cessation counseling and receive nicotine patch continuously for 12 weeks.

The registry classes the interventions as drug.

More on the Plan

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients undergo general smoking cessation counseling and receive varenicline orally (PO) twice daily (QD) on days 1-28.

Courses repeat every 28 days for up to 12 weeks.

ARM II: Patients undergo general smoking cessation counseling and receive nicotine patch continuously for 12 weeks.

Who Took Part

Enrollment: 300 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Cigarette smokers who call the New York State Smokers' Quitline requesting assistance with quitting smoking. State that they are under the care of a primary care physician. Answer "no" to the following 3 questions:. "Have you ever been diagnosed with or treated for a mental health problem like major depression, bipolar disorder, dysthymia, or schizoaffective disorder?". "Have you ever had serious thoughts of killing or hurting yourself, ever have any intention or plan to carry out these thoughts, or actually attempted to kill yourself?".

The full record lists 8 inclusion and 8 exclusion criteria; among the exclusions: state that they are not under the care of a primary care physician; do not speak english; answer "yes" to the question, "is there any reason that you cannot use varenicline/chantix?".

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

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.

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

Nothing was hidden in this open-label Therapeutic nicotine (patch, non-peptide) study: the participants and staff both knew the treatment.

It started in 2012-10-22 with completion listed for 2014-09-28.

It ran at 1 site in United States.

Its stated primary purpose is prevention.

What Was Measured

Researchers chose this as the main measure: Quit Rate (time frame: 4 months).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Therapeutic nicotine (patch, non-peptide) in 300 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.