Internet-Administered Smoking Cessation Treatment for Overweight and Obese Smokers

Plain-language guide to NCT01259466: not phased randomized trial of Therapeutic nicotine (patch, non-peptide), 54 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT01259466
Phase: not phased
Status: completed
Start: 2010-07
Completion (planned or actual): 2013-11
Participants: 54 (actual)
Design: randomized, open label (everyone knows who gets what), treatment
Conditions studied: Smoking Cessation; Overweight; Obesity
Results posted: yes

What This Study Did, in Plain Language

What Was Tested

This registered not phased trial tested Therapeutic nicotine (patch, non-peptide).

Research testing the applicability of these treatments to overweight and obese individuals has not yet been conducted.

It had two arms (groups): Cognitive Behavioral + Nicotine Patch (experimental) and Health Education + Nicotine Patch (active comparator).

Cognitive Behavioral Therapy + Nicotine Replacement Patch.

Health Education + Nicotine Replacement Patch.

The registry classes the interventions as drug.

Who Took Part

The registry lists 54 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

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

Examples of who could join: Smoking 10 or more cigarettes per day. Regular access to the internet.

The full record lists 3 inclusion and 10 exclusion criteria; among the exclusions: type i diabetes or type ii diabetes requiring medication; alcohol or drug dependence within the past year; females with current pregnancy or breastfeeding or intention to become pregnant within the next 12 months.

How the Study Was Run

The set-up was randomized, parallel-group 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.

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 2010-07 with completion listed for 2013-11.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Number of Participants With Verified Smoking Cessation (Abstinence) (time frame: Post-treatment (12-weeks)).

It also tracked 1 secondary outcome, for example Percent Weight Change.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Therapeutic nicotine (patch, non-peptide) in 54 people.

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.