Pharmacokinetic-pharmacodynamic modeling of the effect of varenicline on nicotine craving in adult smokers.

What Was Tested

The paper reports a study of Therapeutic nicotine (patch, non-peptide), published as a randomized controlled trial.

This is the first report describing the concentration-effect relationship of varenicline on relief of craving.

Who Took Part

By PubMed's age tags, the people studied were teenagers, adults and middle-aged adults, both men and women.

Subjects were asked to complete self-reported questionnaires (Smoking Urges Scale and Minnesota Nicotine Withdrawal Scale [MNWS]) and blood samples were simultaneously collected for measurement of varenicline concentrations.

Data were described by a 2-compartment PK model and a linear PD model with first-order onset/offset rate constants describing the placebo response "kinetics." Response was described as the net effect of the baseline, placebo, and drug responses.

How the Study Was Run

The researchers set it up as a randomized, double-blind, placebo-controlled and crossover 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.

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

The comparison arm used a placebo, so changes seen with Therapeutic nicotine (patch, non-peptide) could be set against what happens without it.

In the crossover set-up each of the participants took both Therapeutic nicotine (patch, non-peptide) and the comparison in turn, acting as their own control.

Only the data from the 4-hr postdose abstinence period (just prior to the cue session) were analyzed.

What Was Measured

PubMed files the paper under topics including Benzazepines, Craving, Nicotine, Nicotinic Agonists, Quinoxalines, Smoking and Smoking Cessation.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Therapeutic nicotine (patch, non-peptide).

Results are reported in around 5 sentences of the abstract; we leave them to the paper itself rather than summarise them.

The publication is from 2015 (Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco), a journal based in England.

More context: the Therapeutic nicotine (patch, non-peptide) compound page, all human trials.