QuitAid Pilot Feasibility Trial

What Was Tested

The trial (not phased) is built around Therapeutic nicotine (patch, non-peptide).

It had eight arms (groups): QuitAid, 8 weeks, Patch + Gum (experimental), QuitAid, 4 weeks, Patch + Gum (experimental), QuitAid, 8 weeks, Patch (experimental), QuitAid, 4 weeks, Patch (experimental) and No QuitAid, 8 weeks, Patch + Gum (experimental).

The registry classes the interventions as behavioral and drug.

More on the Plan

No), (2) Combination NRT Gum + NRT Patch (vs.

NRT patch), and/or (3) 8 weeks of NRT (vs. standard 4 weeks).

All participants received 4 weeks of NRT patch in addition to the components to which they were assigned.

Participants completed baseline and 3-month follow-up assessments.

Who Took Part

The registry lists 24 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: Smokers must have smoked at least 5 cigarettes per day for the past 6 months. Be willing to set a quit date in the next 30 days. Own a cell phone. Be over 18 years of age. Not be pregnant or planning to become pregnant in the next 6 months.

The full record lists 6 inclusion and 6 exclusion criteria; among the exclusions: those who are pregnant or plan to be; those under 18 years of age; those with a medical contradiction.

How the Study Was Run

The set-up was randomized, factorial and open-label.

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

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 2021-08-31 with completion listed for 2022-06-27.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Feasibility of recruitment (time frame: 3 months). Feasibility of randomization (time frame: 3 months). Retention (time frame: 3 months).

It also tracked 1 secondary outcome, for example Tobacco Use.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Therapeutic nicotine (patch, non-peptide) in 24 people.

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

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.