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OpenTrials
Completed

NCT Number: NCT02552147

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

Some individuals with autism spectrum disorders (ASD) also demonstrate irritability or aggression, which can interfere with functioning. The purpose of this pilot study is to test whether transdermal nicotine is effective for irritability and/or aggression in adults with ASD using a double-blind, placebo-controlled clinical trial. Subjects will participate in three visits. At the first visit, subjects are screened for eligibility and enrolled. Baseline measures include rating scales and a frustrative computerized task. They will then wear seven days of transdermal nicotine or placebo. Visit two is on day seven and the study measures are repeated, vital signs and side effects monitored. Subjects will return for a third and final visit on day 21 to repeat the study measures performed during visit two.

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Key information

Conditions

Autism Spectrum Disorder Aberrant Motor Behavior in Dementia Aggression Autistic Disorder Behavior Behavioral Symptoms Child Development Disorders, Pervasive Irritability Mental Disorders Neurodevelopmental Disorders Social Behavior

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Yale University

New Haven, Connecticut, 06511, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age: 18-60
  • Gender: All
  • Language: Communicative in English
  • Participants with a prior diagnosis of DSM-5 ASD at some point in their lifetime OR a DSM-4 diagnosis of Autism OR a DSM-4 diagnosis of Asperger's syndrome OR a DSM-4 diagnosis of Pervasive Developmental Disorder Not Otherwise Specified.
  • 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
  • BMI > 17.5 and < 45

Exclusion criteria

  • Age < 18 or > 60
  • BMI < 17.5 or > 45
  • Currently using tobacco or any nicotine products (transdermal, gum, e-cigarettes)
  • Changes in psychotropic medication management within the past 14 days
  • Previous allergy to transdermal patches
  • Patients with heart rate > 100 or < 50 or known history of cardiac rhythm abnormalities
  • Systolic blood pressure > 150 or < 95; diastolic blood pressure > 90 or < 50
  • No symptoms of irritability, agitation, or aggression as reported by parent and/or participant
  • ABC-I score of less than 16
  • No primary caregiver, or primary caregiver unable to assist with rating scales

Treatment and study plan

Transdermal Nicotine

Drug

Transdermal placebo

Other

Primary outcomes

  1. Change From Baseline in Aberrant Behavior Checklist Irritability Subscale (ABC-I)

    Time frame: Baseline and 7 days.

    Aberrant Behavior Checklist (ABC) measures symptom subscales for individuals with neurodevelopmental disorders. The ABC-irritability subscale measures irritability and related symptoms and the subscale score range is 0 (least symptomatic) to 45 (most symptomatic). The ABC is completed by parents/caregivers.

Secondary outcomes

  1. Change in Social Responsiveness Scale-Adults (SRS-A)

    Time frame: Baseline and 7 days.

    The Social Responsiveness Scale (SRS) - 2 quantifies impairments in social behaviors seen in autism spectrum disorder and related conditions and their severity. The version used in this study is completed by parents/caregivers. The raw score range is 0 (unaffected) to > 134 (extremely affected). The ABC is completed by parents/caregivers.

  2. Change in Qualitative Description of Irritability and Aggression Symptoms

    Time frame: Baseline and 7 days

    Brief qualitative reports of the patient's subjective experience will be recorded by asking "In what ways did you find the patch helpful or harmful during the past week, if at all?".

  3. Change in Frustration and Irritability Ratings During Frustration-induction Go-NoGo Task

    Time frame: Baseline and one week

    Subjects will perform a computerized frustration-induction task and complete a rating scale of irritability and frustration levels.

  4. Change in State/Trait Anxiety Inventory (STAI) Score

    Time frame: Baseline and day 7

    The State-Trait Anxiety Inventory (STAI) is a measure of trait and state anxiety. It ranges from a score of 20 (least affected) to 80 (most affected).

  5. Nightly Sleep Quality

    Time frame: Day 7

    Caregivers rated nightly sleep quality from 0 (worst) to 10 (best). Average rating for each treatment week is compared.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • Autism Speaks

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Sep 16, 2015
Registry last updated
May 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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