Evaluate Harm Reduction Products as a Second Line Intervention for Adult Smokers Who Do Not Quit With NRT

What Was Tested

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

Seven-day point abstinence will be used to determine responder status at the end of the four-week period (CO of \<6 ppm at both CO collection points during that seven-day period and self-report of no smoking during that seven-day period).

It had five arms (groups): Group I - NRT Responder (experimental), Group IIa NRT Non-Responder - Pouch Preferrers (experimental), Group IIb NRT Non-Responder - Pouch Preferrers Control (experimental), Group IIIa NRT Non-Responder - ENDS Preferrers (experimental) and Group IIIb NRT Non-Responder - ENDS Preferrers Control (experimental).

Participants that were successful in quitting smoking using NRT in the first four weeks of the study will have the option of remaining on their current NRT or switching to one of the other two options for the next five weeks.

Participants that were unsuccessful in quitting smoking using NRT in the first four weeks and reported a preference to try a nicotine pouch. Randomized to be switched to nicotine pouch for the next five weeks.

Participants that were unsuccessful in quitting smoking using NRT in the first four weeks and reported a preference to try a nicotine pouch. Randomized to be remain on NRT for the next five weeks.

The registry classes the interventions as drug and other.

Who Took Part

The registry lists 4 actual participants took part.

It was open to people of any sex aged from 22 years up to 65 years.

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

Examples of who could join: Has signed the Informed Consent From (ICF) and is able to read and understand the information provided in the ICF. Is 22 to 65 years of age (inclusive) at screening. Expired air CO reading of at least 10 ppm as assessed at the screening session. Interested in switching to an electronic cigarette or nicotine pouch. Willing and able to comply with the requirements of the study.

The full record lists 7 inclusion and 10 exclusion criteria; among the exclusions: planned use of an fda-approved smoking cessation product during the study, not provided as part of this protocol; taking psychoactive medications (e.g., antipsychotics, benzodiazepines, or mood stabilizers); use of nicotine replacement therapy or other smoking cessation treatments within 14 days of screening.

How the Study Was Run

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

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.

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

It started in 2023-12-27 with completion listed for 2024-04-30.

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

Its stated primary purpose is treatment.

What Was Measured

It also tracked 2 secondary outcomes, for example Smoking abstinence rates for NRT non-responders and Smoking abstinence rates for NRT non-responders.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Therapeutic nicotine (patch, non-peptide) in 4 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.