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

Phase 1

Completed

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.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Transdermal nicotine first, placebo last	Transdermal placebo	Subject will receive transdermal nicotine 7 mg daily for 7 days, placebo patch for 7 days, then placebo patch for a final 7 days.
Transdermal placebo first, nicotine last	Transdermal nicotine	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.
Transdermal placebo first, nicotine last	Transdermal placebo	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.
Transdermal nicotine first, placebo last	Transdermal nicotine	Subject will receive transdermal nicotine 7 mg daily for 7 days, placebo patch for 7 days, then placebo patch for a final 7 days.

Primary Outcome Measures

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

Name	Time	Method
Change in Social Responsiveness Scale-Adults (SRS-A)	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.
Change in Qualitative Description of Irritability and Aggression Symptoms	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?".
Change in Frustration and Irritability Ratings During Frustration-induction Go-NoGo Task	Baseline and one week	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	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).
Nightly Sleep Quality	Day 7	Caregivers rated nightly sleep quality from 0 (worst) to 10 (best). Average rating for each treatment week is compared.