Meclizine as a Potential Smoking Cessation Treatment

What Was Tested

This registered phase 2 trial tested Therapeutic nicotine (patch, non-peptide).

This study will also investigate the potential relationship between genes you have inherited and success in quitting smoking.

It had three arms (groups): Placebo + Nicotine Patch (active comparator), one (experimental) and one (experimental).

The registry classes the interventions as drug.

Who Took Part

146 actual participants took part.

It was open to people of any sex 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 10 cigarettes per day;. Have smoked at least one cumulative year;. Have an afternoon expired air carbon monoxide (CO) reading of at least 10ppm;.

The full record lists 14 inclusion and 38 exclusion criteria; among the exclusions: inability to attend all required experimental sessions;; hypotension with symptoms (systolic \<90 mm hg, diastolic \<60 mm hg); coronary heart disease;.

How the Study Was Run

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

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.

Blinding on both sides kept the participants and researchers unaware of who received Therapeutic nicotine (patch, non-peptide).

Those kept unaware of assignments: participant and investigator.

It started in 2011-08 with completion listed for 2012-12.

It ran at 4 sites in United States (4).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Percentage of Change in Expired Air Carbon Monoxide (CO) at End of Week 1 (time frame: After 1 week of treatment (relative to baseline)). Percentage of Change in Expired Air Carbon Monoxide (CO) at End of Week 3 (time frame: After 3 weeks of treatment (relative to baseline)).

It also tracked 3 secondary outcomes, for example Number of Participants Completing the Continuous 4 Week Abstinence From Smoking, Percentage of Change of CO at End of Week 1 When Comparing Abstinent Smokers Versus Non-abstinent Smokers and Percentage of Change of CO at End of Week 3 When Comparing Abstinent Smokers Versus Non-abstinent Smokers.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Therapeutic nicotine (patch, non-peptide) in 146 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.