Personalized Dosing of Nicotine Replacement (NRT to Effect)

What Was Tested

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

It had three arms (groups): one (experimental), Placebo Condition (placebo comparator) and Quit condition (active comparator).

The registry classes the interventions as drug.

More on the Plan

A total of 500 smokers will be enrolled from two smoking cessation clinics to participate in this study.

In addition to the medication, participants in all groups will receive brief behavioral counselling.

Subjects will return to the clinic at weeks 26 and 52 to assess whether or not they are still abstinent from smoking and self-reports of non-smoking will be confirmed using a urine test for nicotine by-product (cotinine) levels.

Exhaled carbon monoxide (CO) will be recorded as an additional measure.

Who Took Part

The registry lists 211 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

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

Examples of who could join: Daily tobacco smoker of ≥10 cigarettes per day. Aged 18 to 75 years old. Interested in using tNRT as the only smoking cessation aid. Intending to quit smoking within the next 30 days.

The full record lists 4 inclusion and 10 exclusion criteria; among the exclusions: at least weekly use of tobacco products other than cigarettes and not willing to stop for the duration of the study; 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 quadruple-blind.

The participants were allocated by chance, so the Therapeutic nicotine (patch, non-peptide) group and the comparison group should start out alike.

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

As a double-blind Therapeutic nicotine (patch, non-peptide) study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2018-01-23 with completion listed for 2023-02-27.

It ran at 2 sites in Canada (2).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Short term continuous abstinence (time frame: weeks 9 to 12).

It also tracked 2 secondary outcomes, for example Long term continuous abstinence and Long term continuous abstinence.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Therapeutic nicotine (patch, non-peptide) in 211 people.

The trial is marked completed; 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.