Nicotinic Cholinergic Modulation as a Novel Treatment Strategy for Aggression Associated With Autism

What Was Tested

This registered phase 1 trial tested Therapeutic nicotine (patch, non-peptide).

Subjects will participate in three visits.

It had two arms (groups): Transdermal nicotine first, placebo last (experimental) and Transdermal placebo first, nicotine last (experimental).

The registry classes the interventions as drug and other.

Who Took Part

Enrollment: 8 actual participants took part.

It was open to people of any sex aged from 18 years up to 60 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Language: Communicative in English. Symptoms of irritability, agitation or aggression as reported by parent and/or participant. Aberrant behavior checklist - Irritability Subscale (ABC-I) score of 16 or higher. No changes in psychotropic medications within the past 14 days. Either lives with a primary caregiver or closely engaged with a primary caregiver who interacts with the patient daily.

The full record lists 9 inclusion and 10 exclusion criteria; among the exclusions: age \< 18 or \> 60; BMI \< 17.5 or \> 45; currently using tobacco or any nicotine products (transdermal, gum, e-cigarettes).

How the Study Was Run

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

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.

Neither the participants nor the staff measuring them knew who was on Therapeutic nicotine (patch, non-peptide), so expectations could not easily colour the readings.

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

It started in 2015-09 with completion listed for 2017-11-17.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change From Baseline in Aberrant Behavior Checklist Irritability Subscale (ABC-I) (time frame: Baseline and 7 days).

It also tracked 5 secondary outcomes, for example Change in Social Responsiveness Scale-Adults (SRS-A), Change in Qualitative Description of Irritability and Aggression Symptoms, Change in Frustration and Irritability Ratings During Frustration-induction Go-NoGo Task, Change in State/Trait Anxiety Inventory (STAI) Score and Nightly Sleep Quality.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Therapeutic nicotine (patch, non-peptide) in 8 people.

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

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.