Assessment of High Dose Transdermal Nicotine for Fast Metabolizers of Nicotine

What Was Tested

In this phase 2 trial, researchers set out to test Therapeutic nicotine (patch, non-peptide).

Unfortunately, the investigators still need to assess and identify novel ways to help people quit smoking.

Differences between people in terms of how fast they metabolize nicotine influences response to transdermal nicotine patches, the most popular nicotine dependence treatment, and it affects plasma levels of nicotine from treatment.

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

The registry classes the interventions as drug.

More on the Plan

Novel approaches to treating nicotine dependence remain a priority.

The transdermal nicotine patch is the most widely used form of tobacco dependence treatment, but only \~1 in 5 smokers who use this treatment achieve cessation.

One factor that may contribute to a poor response to transdermal nicotine is inter-individual variability in the rate of nicotine metabolism, which can be measured in saliva by the ratio of 3'hydroxycotinine (3-HC) to its precursor cotinine.

Among abstainers in these trials, the 3-HC/cotinine ratio also predicts therapeutic levels of nicotine on transdermal nicotine, with faster metabolizers of nicotine exhibiting lower nicotine.

Who Took Part

Enrollment: 87 actual participants took part.

It was open to people of any sex aged from 18 years up to 45 years.

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

Examples of who could join: Males and females age 18-45 who smoke \> 10 cigarettes/ day;. Able to communicate in English;. Able to provide written informed consent for study procedures;. Residing in the geographic area for at least 6 months; and.

The full record lists 6 inclusion and 17 exclusion criteria; among the exclusions: history of substance abuse or currently receiving treatment for substance abuse (e.g., alcohol, opioids, cocaine, marijuana);; current (last 6-months) alcohol consumption that exceeds 25 standard drinks/week; current use or discontinuation within last 14 days of:.

How the Study Was Run

It was run as a randomized, factorial and triple-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.

As a double-blind Therapeutic nicotine (patch, non-peptide) study, the assignments were hidden from both participants and investigators until the end.

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

It started in 2009-08 with completion listed for 2011-08.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Biochemically Verified 7-day Point Prevalence Abstinence at the End of 8 Weeks of Treatment (time frame: After 8 weeks of treatment with the patch, outcome will be measured).

It also tracked 1 secondary outcome, for example Side Effects.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Therapeutic nicotine (patch, non-peptide) in 87 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.