Extended Treatment for Smoking Cessation

What Was Tested

In this phase 4 trial, researchers set out to test Therapeutic nicotine (patch, non-peptide).

Adult smokers (21-65) and adolescent smokers (18 - 21) years of age residing in Alameda and Santa Clara counties will serve as the target population for this study.

A total of 400 smokers meeting eligibility criteria will be randomized.

Treatment will include both open label and extended treatment phases.

It had two arms (groups): Non-extended treatment (active comparator) and Extended treatment (experimental).

The registry classes the interventions as drug.

More on the Plan

During open label treatment, all receive CBT and bupropion and nicotine patch.

At week 10 those who continue to smoke will be switched to varenicline through week 26.

At week 10 those who are abstinent and report low levels of craving and low levels of depression symptoms will be withdrawn from study medications.

Those who are abstinent but report difficulty with craving or depression symptoms will remain on zyban and nicotine replacement therapy (NRT) through week 26.

Who Took Part

223 actual participants took part.

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

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

Examples of who could join: Age at least 18 years at the beginning of the study Smoking at least 10 cigarettes a day (1/2 pack).

The full record lists 1 inclusion and 12 exclusion criteria; among the exclusions: currently pregnant; currently breastfeeding; currently diagnosed with a seizure disorder, major depression, liver disease, kidney disease, congestive heart failure or diabetes mellitus.

How the Study Was Run

Design: 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.

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

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

Those kept unaware of assignments: care provider and investigator.

It started in 2010-03 with completion listed for 2015-03.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Expired-air CO Verified Point-prevalence Abstinence (time frame: 52 weeks).

It also tracked 1 secondary outcome, for example Expired-air CO Verified Point-prevalence Abstinence.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Therapeutic nicotine (patch, non-peptide) in 223 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.