Phase 1
Completed N=8
Nicotinic Cholinergic Modulation as a Novel Treatment Strategy for Aggression Associated With Autism
Autism Spectrum Disorder · Aggression · Irritability
Source: ClinicalTrials.gov NCT02552147 ↗
Enrolled (actual)
8
Serious AEs
0.0%
Results posted
Mar 2019
Primary outcomePrimary: Change From Baseline in Aberrant Behavior Checklist Irritability Subscale (ABC-I) — -12; -7 units on a scale — p=.44
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Aberrant Behavior Checklist Irritability Subscale (ABC-I) |
-12; -7 | .44 |
| SECONDARY Change in Social Responsiveness Scale-Adults (SRS-A) |
-1; -15 | 0.38 |
| SECONDARY Change in Qualitative Description of Irritability and Aggression Symptoms |
— | — |
| SECONDARY Change in Frustration and Irritability Ratings During Frustration-induction Go-NoGo Task |
— | — |
| SECONDARY Change in State/Trait Anxiety Inventory (STAI) Score |
— | — |
| SECONDARY Nightly Sleep Quality |
10; 9 | 0.13 |
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 60
- BMI 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 150 or 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
Data sourced from ClinicalTrials.gov (NCT02552147). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.