Interactive Voice Response Technology to Mobilize Contingency Management for Smoking Cessation

Plain-language guide to NCT01484717: phase 2 randomized trial of Therapeutic nicotine (patch, non-peptide), 90 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT01484717
Phase: phase 2
Status: completed
Start: 2012-01
Completion (planned or actual): 2014-12
Participants: 90 (actual)
Design: randomized, open label (everyone knows who gets what), treatment
Conditions studied: Cigarette Smoking
Results posted: not yet

What This Study Did, in Plain Language

What Was Tested

The trial (phase 2) is built around Therapeutic nicotine (patch, non-peptide).

Expired carbon monoxide (CO) is the most common objective smoking status test used in smoking research and treatment.

It had two arms (groups): Standard Care (active comparator) and Contingency management for abstinence from cigarettes (experimental).

Telephone counseling plus nicotine patch.

Telephone counseling and nicotine patch plus contingency management.

The registry classes the interventions as behavioral and drug.

Who Took Part

Enrollment: 90 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: Regular cigarette smoker. Age ≥ 18. Mailing address \& valid photo I.D. Want transdermal nicotine.

The full record lists 4 inclusion and 4 exclusion criteria; among the exclusions: not english speaking; in recovery for pathological gambling; contraindication for transdermal nicotine.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

Random assignment meant chance, not the researchers, decided who got Therapeutic nicotine (patch, non-peptide) and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

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

It started in 2012-01 with completion listed for 2014-12.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Longest duration of abstinence (time frame: Week 24).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Therapeutic nicotine (patch, non-peptide) in 90 people.

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.

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.