Improving the Population-Wide Effectiveness of U.S. Tobacco Cessation Quitlines

Plain-language guide to NCT01087905: phase 4 randomized trial of Therapeutic nicotine (patch, non-peptide), 987 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT01087905
Phase: phase 4
Status: completed
Start: 2010-04
Completion (planned or actual): 2011-02
Participants: 987 (actual)
Design: randomized, single-blind, treatment
Conditions studied: Smoking; Smoking Cessation
Results posted: yes

What This Study Did, in Plain Language

What Was Tested

This registered phase 4 trial tested Therapeutic nicotine (patch, non-peptide).

It had eight arms (groups): 2 Weeks of Nicotine Patch Only, No CMAC (active comparator), 2 Weeks of Nicotine Patch Only plus CMAC (active comparator), 2 Wks Nicotine Patch+Nic Gum, No CMAC (active comparator), 2 Wks Nicotine Patch+Nic Gum plus CMAC (active comparator) and 6 Weeks of Nicotine Patch Only, No CMAC (active comparator).

The registry classes the interventions as behavioral and drug.

More on the Plan

This design provides them with sufficient power to analyze each of their three main effects listed above.

The researchers will also test for two- and three-way interactions, but do not have sufficient data to make a priori assumptions about interaction effects.

Who Took Part

The registry lists 987 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.

The full record lists 1 inclusion and 1 exclusion criteria.

How the Study Was Run

Design: randomized, factorial and single-blind.

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

In this single-blind Therapeutic nicotine (patch, non-peptide) study one party knew the assignments and the other did not.

Those kept unaware of assignments: outcomes assessor.

It started in 2010-04 with completion listed for 2011-02.

It ran at 2 sites in United States (2).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: 7-Day Point Prevalence Abstinence From Smoking by Intervention (time frame: 26 weeks after the target quit smoking date). 7-Day Point Prevalence Abstinence From Smoking by Nicotine Replacement Therapy (NRT) Group (time frame: 26 weeks after the target quit smoking date).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Therapeutic nicotine (patch, non-peptide) in 987 people.

With 987 participants it is a large trial for this field.

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.