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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 May 2022
• Main ID: NCT02552147
• Date of registration: 14/09/2015
• Prospective Registration: No
• Primary sponsor: Yale University
• Public title: Nicotinic Cholinergic Modulation as a Novel Treatment Strategy for Aggression Associated With Autism
• Scientific title: Nicotinic Cholinergic Modulation as a Novel Treatment Strategy for Aggression Associated With Autism
• Date of first enrolment: September 2015
• Target sample size: 8
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02552147
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: Alan S Lewis, MD, PhD
• Affiliation: Lecturer in psychiatry

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 60 Years
Gender: All

Health Condition(s) or Problem(s) studied

Irritability

Autism Spectrum Disorder

Aggression

Intervention(s)

Other: Transdermal placebo

Drug: Transdermal nicotine

Primary Outcome(s)

Change From Baseline in Aberrant Behavior Checklist Irritability Subscale (ABC-I) [Time Frame: Baseline and 7 days.]

Secondary Outcome(s)

Change in Social Responsiveness Scale-Adults (SRS-A) [Time Frame: Baseline and 7 days.]

Nightly Sleep Quality [Time Frame: Day 7]

Change in Frustration and Irritability Ratings During Frustration-induction Go-NoGo Task [Time Frame: Baseline and one week]

Change in Qualitative Description of Irritability and Aggression Symptoms [Time Frame: Baseline and 7 days]

Change in State/Trait Anxiety Inventory (STAI) Score [Time Frame: Baseline and day 7]

Secondary ID(s)

1502015384

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Autism Speaks

Results

• Results available: Yes
• Date Posted: 14/03/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02552147