Innovative Interventions for Smoking Cessation

What Was Tested

In this phase 2 trial, researchers set out to test Therapeutic nicotine (patch, non-peptide).

The study will determine if adding nicotine replacement medication to the very low content cigarettes (VLNC) will augment treatment compared to nicotine patch only or to very low nicotine content cigarettes only.

It had three arms (groups): VLNC Cigarette (active comparator), Nicotine Patch (active comparator) and VLNC Cigarette plus Nicotine Patch (experimental).

The registry classes the interventions as drug and other.

More on the Plan

The following primary hypothesis will be tested: Abstinence rates will be highest and the time to relapse will be the longest in the VLNC cigarettes plus nicotine patch condition compared to nicotine patch or VLNC cigarettes alone.

Greater positive subjective responses to cigarettes will be observed with VLNC cigarettes plus patch vs.

Less drop-outs will be observed in the VLNC plus patch vs the other two conditions; and 3.

Less compensatory smoking will be observed in the VLNC plus patch condition compared to VLNC cigarette alone condition.

Who Took Part

Enrollment: 235 actual participants took part.

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

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

Examples of who could join: A) Smoking at least 10 cigarettes daily for the past year;. B) In good physical health;. C) No contraindications for medicinal nicotine; and. D) Stable, good mental health.

The full record lists 4 inclusion and 2 exclusion criteria; among the exclusions: a) subjects must not be using other tobacco or nicotine products; b) female subjects cannot be pregnant or nursing and must be using appropriate birth control.

How the Study Was Run

Design: randomized, factorial 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.

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

It started in 2008-10 with completion listed for 2011-12.

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

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: End of Treatment Abstinence Rate (time frame: 12 week). End of Follow-up Abstinence Rates (time frame: 36 weeks).

It also tracked 2 secondary outcomes, for example Exposure to Tobacco Toxicants and Time to Lapse or Relapse to Tobacco Use.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Therapeutic nicotine (patch, non-peptide) in 235 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.