Evaluation of Moclobemide, a Reversible MAO-A Inhibitor, as an Adjunct to Nicotine Replacement Therapy in Female Smokers

Plain-language guide to NCT01926626: phase 2 interventional trial of Therapeutic nicotine (patch, non-peptide), 76 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT01926626
Phase: phase 2
Status: completed
Start: 2013-09
Completion (planned or actual): 2014-07
Participants: 76 (actual)
Design: na, open label (everyone knows who gets what), treatment
Conditions studied: Nicotine Dependence
Results posted: yes

What This Study Did, in Plain Language

What Was Tested

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

It had 1 arm (groups): Nicotine Patch+Moclobemide (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 76 actual participants took part.

It was open to women only aged from 18 years up to 65 years.

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

Examples of who could join: Have no known serious medical conditions;. Are 18-65 years old;. Smoke an average of at least 20 cigarettes per day;. Have smoked at least one cumulative year;. Have a Fagerstrom Test for Nicotine Dependence score of at least 5;.

The full record lists 19 inclusion and 37 exclusion criteria; among the exclusions: hypotension with symptoms;; coronary heart disease;; lifetime history of heart attack;.

How the Study Was Run

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

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.

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

It started in 2013-09 with completion listed for 2014-07.

It ran at 3 sites in United States (3).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Continuous Four-week Abstinence From Smoking (time frame: Weeks 6-10 post quit day).

It also tracked 4 secondary outcomes, for example Point Abstinence From Smoking at Six Months Post Quit, Continuous Ten Week Abstinence From Smoking, Percentage of Change in Smoking Withdrawal Symptoms and Percentage of Change in Expired Air Carbon Monoxide (CO) During the First Week of Nicotine Patch Treatment.

What This Means in Plain Language

Put simply, this is a phase 2 trial of Therapeutic nicotine (patch, non-peptide) in 76 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.