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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
8
Yale University
New Haven, Connecticut, United States
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.
Time frame: Baseline and 7 days.
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.
Time frame: Baseline and 7 days.
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?".
Time frame: Baseline and 7 days
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.
Time frame: Baseline and one week
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).
Time frame: Baseline and day 7
Nightly Sleep Quality
Caregivers rated nightly sleep quality from 0 (worst) to 10 (best). Average rating for each treatment week is compared.
Time frame: Day 7
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