Combined Nortriptyline and Transdermal Nicotine for Smoking Cessation

Plain-language guide to NCT00018148: phase 2 randomized trial of Therapeutic nicotine (patch, non-peptide), 158 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT00018148
Phase: phase 2
Status: completed
Start: 1998-04
Completion (planned or actual): 2002-12
Participants: 158 (actual)
Design: randomized, quadruple-blind, treatment
Conditions studied: 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).

The study is a placebo-controlled, randomized, parallel group trial in which smokers aged 18-70 will be subject to the combination of oral and patch treatments.

It had two arms (groups): 1 (experimental) and 2 (active comparator).

Transdermal nicotine plus nortriptyline.

Transdermal nicotine plus placebo.

The registry classes the interventions as drug.

Who Took Part

158 actual participants took part.

It was open to people of any sex aged from 18 years up to 70 years.

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

Examples of who could join: Smoking \> 10 cigarettes per day,. No current major depression,. No concurrent psychiatric medications.

The full record lists 4 inclusion and 0 exclusion criteria.

How the Study Was Run

Design: randomized, parallel-group and quadruple-blind.

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.

Neither the participants nor the staff measuring them knew who was on Therapeutic nicotine (patch, non-peptide), so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 1998-04 with completion listed for 2002-12.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Validated smoking cessation (time frame: 6 months).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Therapeutic nicotine (patch, non-peptide) in 158 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.