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

May 4, 2022 updated by: Yale University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06511
        • Yale University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Transdermal nicotine first, placebo last
Subject will receive transdermal nicotine 7 mg daily for 7 days, placebo patch for 7 days, then placebo patch for a final 7 days.
Drug: Transdermal nicotine
Other: Transdermal placebo
Experimental: Transdermal placebo first, nicotine last
Subject will receive transdermal placebo daily for 7 days, placebo patch for another 7 days, then transdermal nicotine 7 mg daily for a final 7 days.
Drug: Transdermal nicotine
Other: Transdermal placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and 7 days.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and 7 days.
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?".
Baseline and 7 days
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.
Baseline and one week
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).
Baseline and day 7
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.
Day 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Collaborators

Autism Speaks

Investigators

  • Principal Investigator: Alan S Lewis, MD, PhD, Lecturer in psychiatry

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Actual)

November 17, 2017

Study Completion (Actual)

November 17, 2017

Study Registration Dates

First Submitted

September 14, 2015

First Submitted That Met QC Criteria

September 15, 2015

First Posted (Estimate)

September 16, 2015

Study Record Updates

Last Update Posted (Actual)

May 6, 2022

Last Update Submitted That Met QC Criteria

May 4, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1502015384

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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