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

Primary Purpose

Autism Spectrum Disorder, Aggression, Irritability

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Transdermal nicotine
Transdermal placebo
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder focused on measuring Autism spectrum disorder, Aggression, Irritability, Nicotine, Nicotinic acetylcholine receptor, Nicotinic agonist, Adult autism

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Yale University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Transdermal nicotine first, placebo last

Transdermal placebo first, nicotine last

Arm Description

Subject will receive transdermal nicotine 7 mg daily for 7 days, placebo patch for 7 days, then placebo patch for a final 7 days.

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.

Outcomes

Primary Outcome Measures

Change From Baseline in Aberrant Behavior Checklist Irritability Subscale (ABC-I)
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 Outcome Measures

Change in Social Responsiveness Scale-Adults (SRS-A)
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.
Change in Qualitative Description of Irritability and Aggression Symptoms
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?".
Change in Frustration and Irritability Ratings During Frustration-induction Go-NoGo Task
Subjects will perform a computerized frustration-induction task and complete a rating scale of irritability and frustration levels.
Change in State/Trait Anxiety Inventory (STAI) Score
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).
Nightly Sleep Quality
Caregivers rated nightly sleep quality from 0 (worst) to 10 (best). Average rating for each treatment week is compared.

Full Information

First Posted
September 14, 2015
Last Updated
May 4, 2022
Sponsor
Yale University
Collaborators
Autism Speaks
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1. Study Identification

Unique Protocol Identification Number
NCT02552147
Brief Title
Nicotinic Cholinergic Modulation as a Novel Treatment Strategy for Aggression Associated With Autism
Official Title
Nicotinic Cholinergic Modulation as a Novel Treatment Strategy for Aggression Associated With Autism
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
November 17, 2017 (Actual)
Study Completion Date
November 17, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
Autism Speaks

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder, Aggression, Irritability
Keywords
Autism spectrum disorder, Aggression, Irritability, Nicotine, Nicotinic acetylcholine receptor, Nicotinic agonist, Adult autism

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Transdermal nicotine first, placebo last
Arm Type
Experimental
Arm Description
Subject will receive transdermal nicotine 7 mg daily for 7 days, placebo patch for 7 days, then placebo patch for a final 7 days.
Arm Title
Transdermal placebo first, nicotine last
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Transdermal nicotine
Intervention Type
Other
Intervention Name(s)
Transdermal placebo
Primary Outcome Measure Information:
Title
Change From Baseline in Aberrant Behavior Checklist Irritability Subscale (ABC-I)
Description
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.
Time Frame
Baseline and 7 days.
Secondary Outcome Measure Information:
Title
Change in Social Responsiveness Scale-Adults (SRS-A)
Description
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.
Time Frame
Baseline and 7 days.
Title
Change in Qualitative Description of Irritability and Aggression Symptoms
Description
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?".
Time Frame
Baseline and 7 days
Title
Change in Frustration and Irritability Ratings During Frustration-induction Go-NoGo Task
Description
Subjects will perform a computerized frustration-induction task and complete a rating scale of irritability and frustration levels.
Time Frame
Baseline and one week
Title
Change in State/Trait Anxiety Inventory (STAI) Score
Description
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).
Time Frame
Baseline and day 7
Title
Nightly Sleep Quality
Description
Caregivers rated nightly sleep quality from 0 (worst) to 10 (best). Average rating for each treatment week is compared.
Time Frame
Day 7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alan S Lewis, MD, PhD
Organizational Affiliation
Lecturer in psychiatry
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States

12. IPD Sharing Statement

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

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