Nicotine and Sensorimotor Replacement for Smoking in Smokers With Schizophrenia

What Was Tested

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

The objective of this study is to investigate the relative contributions of nicotine replacement and sensorimotor replacement (i.e., smoking denicotinized cigarettes) on abstinence-induced smoking urges, withdrawal-related negative affect, psychiatric symptoms, cognitive task performance and 90-min ad libitum usual-brand smoking behavior in smokers with schizophrenia and non-psychiatric smokers.

It had five arms (groups): Active nicotine replacement (NRT) + denicotinized cigarettes (active comparator), Placebo NRT + denicotinized cigarettes (active comparator), Active NRT + no cigarettes (active comparator), Placebo NRT + No cigarettes (placebo comparator) and usual brand smoking (active comparator).

Inactive transdermal patches plus sensorimotor replacement.

The registry classes the interventions as behavioral, drug and other.

More on the Plan

Each session contained a 5-h controlled administration period in which participants underwent the following conditions, in counterbalanced order: VLNC + NIC, VLNC + PLA, no cigarettes + NIC, no cigarettes + PLA, Usual Brand cigarettes + no patches.

Next, participants completed measures of cigarette craving, nicotine withdrawal, smoking habit withdrawal, cigarette subjective effects, psychiatric symptoms and cognitive task performance followed by a 90-min period of ad libitum usual-brand smoking.

Who Took Part

75 actual participants took part.

It was open to people of any sex aged from 18 years up to 99 years.

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

Examples of who could join: Schizophrenia or no psychiatric illness. 18 and older. Men and women. Cigarette smokers, 20-50 cigarettes per day. Would like to quit someday.

The full record lists 5 inclusion and 2 exclusion criteria; among the exclusions: medical conditions excluding transdermal nicotine replacement; pregnancy or lactation.

How the Study Was Run

It was run as a randomized, crossover and double-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.

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.

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 outcomes assessor.

It started in 2005-09 with completion listed for 2011-03.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): Preferred Brand Smoke Intake (CO) (time frame: 90 min).

It also tracked 1 secondary outcome, for example Questionnaire on Smoking Urges - Brief Scale (QSU-Brief).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Therapeutic nicotine (patch, non-peptide) in 75 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.