A Quit Smoking Study Using Smartphones

Plain-language guide to NCT02164383: not phased randomized trial of Therapeutic nicotine (patch, non-peptide), 30 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT02164383
Phase: not phased
Status: completed
Start: 2014-10
Completion (planned or actual): 2016-05
Participants: 30 (actual)
Design: randomized, single-blind, treatment
Conditions studied: Smoking Cessation; Smoking; Nicotine Dependence
Results posted: yes

What This Study Did, in Plain Language

What Was Tested

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

The central hypothesis is that smokers who have access to smartphone games during their quit smoking attempt will smoke fewer cigarettes and report less craving than will smokers without such access.

It had two arms (groups): Mobile Games (experimental) and No Mobile Games (experimental).

The registry classes the interventions as behavioral, device and drug.

Who Took Part

Enrollment: 30 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Being age 18 or older;. Being able to read and write English;. Being willing and able to learn how to use a smartphone if they have not used one before;. Smoking 10 or more cigarettes per day for the past 6 months;. Having an expired carbon monoxide rating of 6 ppm or greater;.

The full record lists 21 inclusion and 1 exclusion criteria.

How the Study Was Run

It was run as a randomized, parallel-group and single-blind 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.

Only one side, usually the participants, was kept unaware of whether Therapeutic nicotine (patch, non-peptide) was given.

Those kept unaware of assignments: outcomes assessor.

It started in 2014-10 with completion listed for 2016-05.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change Between Baseline Mean Cigarettes Smoked Per Day and Mean Cigarettes Smoked Per Day During the First 4 Weeks of the Quit Attempt Calculated as Percentage Change.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Therapeutic nicotine (patch, non-peptide) in 30 people.

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

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.

Our Notes on the Compound

Therapeutic nicotine (patch, non-peptide): Pure nicotine as a signaling tool, separated from smoking and vaping.

Therapeutic nicotine (patch, non-peptide) in the library

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.