An Effectiveness Trial of Maintenance Therapy for Nicotine Dependence

What Was Tested

The trial (phase 4) is built around Therapeutic nicotine (patch, non-peptide).

The transdermal nicotine patch is the most widely used form of tobacco dependence treatment in the US and Europe, but most smokers are unable to successfully quit with this form of treatment.

Failure to respond to this treatment may, to a large extent, be due to the use of nicotine patches for only 8 weeks, the recommended treatment duration.

It had three arms (groups): 8 weeks transdermal nicotine (active comparator), 24 weeks transdermal nicotine (active comparator) and 52 weeks transdermal nicotine (experimental).

8 weeks of transdermal nicotine.

24 weeks of transdermal nicotine.

52 weeks of transdermal nicotine.

The registry classes the interventions as drug.

More on the Plan

The transdermal nicotine patch is the most widely used form of tobacco dependence treatment in the US and Europe.

There is a growing recognition that nicotine dependence is a chronic disease, like asthma or diabetes, which requires maintenance therapy.

While current guidelines established by the USDHHS's Public Health Service (PHS) recommend 8-week duration for transdermal nicotine therapy, support for this recommendation is limited.

In addition, as done in clinical trials to support the use of methadone maintenance for opiate dependence, a replication study must include a treatment arm that receives maintenance therapy throughout the duration of the trial (52 weeks).

Who Took Part

Enrollment: 525 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.

How the Study Was Run

It was run as a randomized, single-group and open-label study.

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.

Everyone knew when Therapeutic nicotine (patch, non-peptide) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2009-06 with completion listed for 2014-04.

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: Point Prevalence Abstinence (time frame: 52-week). Week 24 Point Prevalence Abstinence (time frame: 24-week).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Therapeutic nicotine (patch, non-peptide) in 525 people.

With 525 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.