Electronic Cigarettes and Reactivity to Smoking Cues

Plain-language guide to NCT01782599: not phased interventional trial of Therapeutic nicotine (patch, non-peptide), 125 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT01782599
Phase: not phased
Status: active, not recruiting
Start: 2013-01
Completion (planned or actual): 2027-03-24
Participants: 125 (estimated)
Design: na, open label (everyone knows who gets what), basic_science
Conditions studied: Nicotine Dependence
Results posted: not yet

What This Study Did, in Plain Language

What Was Tested

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

It had 1 arm (groups): Dual nicotine patch and electronic cigarette (experimental).

Nicotine patch and the electronic cigarette will be administered.

The registry classes the interventions as other.

More on the Plan

The only source of nicotine participants will receive during the study will come from NRT.

The researchers will use e-cigarettes that provide no nicotine, yet may provide a similar experience to smoking as e-cigarettes taste and feel similar to a regular cigarette.

Reactivity to smoking cues will be assessed using a battery of measures including: self-report, behavioral, and neuroimaging.

Who Took Part

The registry lists 125 planned participants were the target.

It was open to people of any sex aged from 18 years up to 45 years.

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

Examples of who could join: Provide written informed consent. Be aged 18-45. Report smoking cigarettes daily in the past 6 months. Have expired breath CO indicative of regular smoking. Have a score greater than 0 on the FTND.

The full record lists 8 inclusion and 9 exclusion criteria; among the exclusions: be pregnant (measured via urinalysis); meet current abuse or dependence criteria for any substance other than nicotine or caffeine (measured via the scid 5); produce a positive urine screen for drugs of abuse or alcohol at the fmri scan visits.

How the Study Was Run

It was run as a single-group and open-label study.

Being open-label, the Therapeutic nicotine (patch, non-peptide) study did not mask who received what.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2013-01 with completion listed for 2027-03-24.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What This Means in Plain Language

Put simply, this is a not phased trial of Therapeutic nicotine (patch, non-peptide) in 125 people.

Its status is active not recruiting; 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.

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.