Neuro Biomarkers of Smoking Behavior

What Was Tested

In this phase 2 trial, researchers set out to test Insulin (regular human).

The purpose of this study is to evaluate cognition in smokers and nonsmokers.

It involves administration of intranasal insulin (Novolin R), an investigational medication followed by a brief non-invasive cognitive test.

All participants will receive both Novolin R and placebo in two separate testing sessions.

It had two arms (groups): Smokers (experimental) and Non-Smokers (experimental).

The registry classes the interventions as drug.

More on the Plan

This program of research focuses on identifying neurologic biomarkers of smoking behavior in order to develop individualized smoking cessation aids.

The intranasal insulin administered is an investigational drug and has been granted IND status by the FDA (IND#129432).

During the times of drug effects, the investigators will evaluate a biomarker using computerized tasks.

Non-smokers and smokers will participate in two testing sessions where the biomarker will be critically evaluated after administration of intranasal insulin and compared to the cognitive processes elicited by placebo administration.

Who Took Part

The registry lists 4 actual participants took part.

It was open to people of any sex aged from 21 years up to 40 years.

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

Examples of who could join: Age between 21-40 years. Smokers only: Begin smoking within 5 minutes of waking (verified by carbon monoxide concentrations greater than 10 ppm). Non-smokers only: No self-reported cigarette use in the past 1-year period. Non-smokers only: Carbon monoxide concentration \< 6 ppm. Normal vitals (blood pressure \< 120/80 mmHg; heart rate between 60 and 100 bpm, body temperature \<37 °C).

The full record lists 7 inclusion and 14 exclusion criteria; among the exclusions: use of non-cigarette tobacco products, e-cigarettes, or smoking cessation treatment; positive urine drug screen test; current pregnancy (urine test-verified) or lactation, or a plan to become pregnant.

How the Study Was Run

Design: randomized, crossover and double-blind.

Random assignment meant chance, not the researchers, decided who got Insulin (regular human) and who got the comparison, which limits bias.

Each person switched between Insulin (regular human) and the comparison at some point, usually with a gap in between.

Blinding on both sides kept the participants and researchers unaware of who received Insulin (regular human).

Those kept unaware of assignments: participant and investigator.

It started in 2018-09-12 with completion listed for 2019-09-27.

It ran at 1 site in United States.

Its stated primary purpose is diagnostic.

What Was Measured

Primary outcome: Go/No-Go Accuracy (time frame: From time of drug administration to 70 minutes following drug administration, up to 90 minutes).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Insulin (regular human) in 4 people.

Its size is small, so on its own it can only give an early look.

It ended early (terminated); results are posted on the registry, and this page does not restate them.

More context: the Insulin (regular human) compound page, all human trials.