Comparison of Standard Versus Extended Nicotine Patch Therapy for Smoking Cessation

What Was Tested

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

All participants will receive behavioral counseling.

It had two arms (groups): Extended Patch Treatment (experimental) and Standard Patch Treatment (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 568 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: Males and females of descent between the ages of 18-65 who smokes at least 10 cigarettes/day and are seeking smoking cessation treatment. Following orientation by the research staff, subjects must sign written informed consent for all study procedures.

The full record lists 3 inclusion and 6 exclusion criteria; among the exclusions: women who are pregnant, planning a pregnancy, or lactating; current dsm iv substance use disorders (dependence involving alcohol, cocaine, marijuana or stimulants, benzodiazepines); current use of tn or other forms of nrt.

How the Study Was Run

The set-up was 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.

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

Those kept unaware of assignments: participant and investigator.

It started in 2004-06 with completion listed for 2008-04.

It ran at 2 sites in United States (2).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Biochemically Verified 7-day Point Prevalence Abstinence (time frame: End of Treatment (week 24)).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Therapeutic nicotine (patch, non-peptide) in 568 people.

With 568 participants it is a large trial for this field.

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.