Clinical trial NCT02552147: Nicotinic Cholinergic Modulation as a Novel Treatment Strategy for Aggression Associated With Autism
Official title: Nicotinic Cholinergic Modulation as a Novel Treatment Strategy for Aggression Associated With Autism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Autism Spectrum Disorder
Aggression
Irritability
Keywords: Autism spectrum disorder
Aggression
Irritability
Nicotine
Nicotinic acetylcholine receptor
Nicotinic agonist
Adult autism
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Autism Speaks
First posted: 2015-09-16
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change From Baseline in Aberrant Behavior Checklist Irritability Subscale (ABC-I)
timeFrame: Baseline and 7 days.
Secondary outcomes:
measure: Change in Social Responsiveness Scale-Adults (SRS-A)
timeFrame: Baseline and 7 days.
measure: Change in Qualitative Description of Irritability and Aggression Symptoms
timeFrame: Baseline and 7 days
measure: Change in Frustration and Irritability Ratings During Frustration-induction Go-NoGo Task
timeFrame: Baseline and one week
measure: Change in State/Trait Anxiety Inventory (STAI) Score
timeFrame: Baseline and day 7
measure: Nightly Sleep Quality
timeFrame: Day 7
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
Study officials:
affiliation: Lecturer in psychiatry
name: Alan S Lewis, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: