Adjustment of DOses of NIcotine in Smoking Cessation (ADONIS)

What Was Tested

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

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

Adaptation of the nicotine patch with salivary cotinine.

Normal following with a nicotine patch.

The registry classes the interventions as drug and procedure.

More on the Plan

Smokers currently smoking at least 10 cigarettes per day with smoking related diseases are included.

In the control arm, at the discretion of the investigators, buccal forms of nicotine replacement therapies are allowed.

In both arms, saliva cotinine determinations are performed every 2 weeks for 2 months.

In the control arm saliva cotinine results are not communicated to the investigators.

Who Took Part

300 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: Age ≥18 years Smoking ≥ 10 cigarettes per day Patients with disease conditions known to be related to smoking: e.g.coronary heart diseases, COPD, lower extremity arterial disease, etc.

The full record lists 1 inclusion and 6 exclusion criteria; among the exclusions: smokers whose follow-up during the duration of the study, in a predictable way, cannot be assured; smokers having been treated by bupropion ( zyban) during two months preceding the inclusion; persons under tsn, neuroleptic, substitute treatments in opinoides, under anticoagulants-non-equilibrating,.

How the Study Was Run

It was run as a randomized, parallel-group and single-blind study.

Because people in this Therapeutic nicotine (patch, non-peptide) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

Only one side, usually the participants, was kept unaware of whether Therapeutic nicotine (patch, non-peptide) was given.

Those kept unaware of assignments: participant.

It started in 2005-10 with completion listed for 2007-11.

It ran at 1 site in France.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: sustained smoking abstinence (time frame: during the study).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Therapeutic nicotine (patch, non-peptide) in 300 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.