Nicotinic Cholinergic Modulation as a Novel Treatment Strategy for Aggression Associated With Autism
Condition: Autism Spectrum Disorder; Aggression; Irritability
MeSH terms: Autistic Disorder; Autism Spectrum Disorder; Aggression
Intervention: Transdermal nicotine; Transdermal placebo
Intervention MeSH terms: Nicotine
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Autism spectrum disorder; Aggression; Irritability; Nicotine; Nicotinic acetylcholine receptor; Nicotinic agonist; Adult autism

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.
    

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