NCT02552147

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Autism Spectrum Disorder
• Aggression
• Irritability

Interventions

Type	Name	Description
DRUG	Transdermal nicotine
OTHER	Transdermal placebo

Timeline

• Start date: 2015-09-01
• Primary completion: 2017-11-17
• Completion: 2017-11-17
• First posted: 2015-09-16
• Last updated: 2022-05-06
• Results posted: 2019-03-14

Locations

1 site across 1 country: United States