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

Autism Spectrum Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02552147
• Other study ID #: 1502015384
• Status: Completed
• Phase: Phase 1
• Start date: September 2015
• Est. completion date: November 17, 2017

Study information

• Verified date: May 2022
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: November 17, 2017
• Est. primary completion date: November 17, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Aggression
• Autism Spectrum Disorder
• Autistic Disorder
• Irritability

Intervention

Drug:
• Transdermal nicotine

Other:
• Transdermal placebo

Locations

Country	Name	City	State
United States	Yale University	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	Autism Speaks

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline and 7 days.
Secondary	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.	Baseline and 7 days.
Secondary	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?".	Baseline and 7 days
Secondary	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.	Baseline and one week
Secondary	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).	Baseline and day 7
Secondary	Nightly Sleep Quality	Caregivers rated nightly sleep quality from 0 (worst) to 10 (best). Average rating for each treatment week is compared.	Day 7