Efficacy and Neural Correlates of Personalized Treatment With Transdermal Nicotine Replacement

What Was Tested

The trial (phase 2, phase 3) is built around Therapeutic nicotine (patch, non-peptide).

Functional Magnetic Resonance Imaging scans will also be obtained from all study participants before and after treatment.

It had two arms (groups): one (experimental) and Positive Control Arm (active comparator).

The registry classes the interventions as drug.

More on the Plan

The primary outcome measure will be continuous abstinence during the last 4 weeks of treatment.

In addition, participants will be assessed to see how treatment has impacted their resting state neural activity as well as their responsiveness to smoking and emotional cues.

Follow up sessions will be used to assess long term abstinence as well as long term change in neural activation.

Who Took Part

18 actual participants took part.

It was open to people of any sex aged from 19 years up to 65 years.

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

Examples of who could join: Daily tobacco smoker of. Aged 19 to 65 years old. Intending to quit smoking within the next 30 days. Interested in using transdermal nicotine replacement therapy (nicotine patch).

The full record lists 4 inclusion and 9 exclusion criteria; among the exclusions: at least weekly use of tobacco products other than cigarettes; breast feeding, pregnancy or not using a reliable form of birth control; any generalized skin disorders precluding the use of the patch.

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.

Groups ran in parallel: each of the participants stayed in one arm throughout.

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.

It started in 2015-07 with completion listed for 2017-12.

It ran at 1 site in Canada.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: 4 weeks continuous smoking abstinence (time frame: Treatment weeks 9-12 inclusive).

It also tracked 1 secondary outcome, for example Cue induced brain activation.

What This Means in Plain Language

Put simply, this is a phase 2, phase 3, randomized trial of Therapeutic nicotine (patch, non-peptide) in 18 people.

Its size is small, so on its own it can only give an early look.

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Therapeutic nicotine (patch, non-peptide) compound page, all human trials.