Menstrual Cycle Effects on Smoking Cessation and Cue Reactivity

What Was Tested

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

This is a brief smoking cessation trial in women, comparing transdermal nicotine patch (TNP) versus varenicline.

It had two arms (groups): Varenicline (experimental) and Transdermal Nicotine Patch (active comparator).

Participant randomized to receive active varenicline and placebo transdermal nicotine patch.

Participant randomized to receive active transdermal nicotine patch and placebo varenicline.

The registry classes the interventions as device and drug.

More on the Plan

This component builds directly upon the results of the previously funded project in systematically investigating the impact of short-term ovarian hormone fluctuation on females as they try to quit smoking with the aid of either transdermal nicotine patch (TNP) or varenicline.

Each participant will receive a standardized impulsivity evaluation and a laboratory-based cue reactivity assessment before the initiation of smoking cessation.

Progesterone and estrogen levels will be measured at each of nine visits, thereby providing an index of reproductive hormone variation over the course of each participant's quit attempt.

This novel approach of integrating a human laboratory cue reactivity paradigm directly with a treatment outcome study will permit them to assess whether or not smoking cue reactivity has predictive utility with respect to cessation outcome.

Who Took Part

140 actual participants took part.

It was open to women only aged from 18 years up to 45 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Age 18-45. Individuals over the age of 45 will not be included as the researchers are examining the effects of menstrual cycle and ovarian hormones. Daily smokers who smoke at least 10 cigarettes per day for at least past 6 months. Post menarche and pre menopausal. Regular menstrual cycle between 25 and 35 days. At least three months post delivery and breast feeding.

The full record lists 7 inclusion and 12 exclusion criteria; among the exclusions: any unstable major axis i psychiatric disorder in the past month; current substance use disorders other than nicotine and caffeine use, in the past 30 days; any medication that may interfere with psychophysiological monitoring.

How the Study Was Run

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

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

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 2007-07 with completion listed for 2013-12.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: End-of-treatment Abstinence (time frame: 2 weeks).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Therapeutic nicotine (patch, non-peptide) in 140 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.