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

Yale University

Status and phase: Completed; Phase 1

Conditions: Aggression; Autism Spectrum Disorder; Irritability

Treatments: Other: Transdermal placebo; Drug: Transdermal nicotine

Study type: Interventional

Funder types: Other

Identifiers

NCT02552147

1502015384

Details and patient eligibility

About

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.

Enrollment: 8 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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8 participants in 2 patient groups

Transdermal nicotine first, placebo last

Experimental group

Description:

Subject will receive transdermal nicotine 7 mg daily for 7 days, placebo patch for 7 days, then placebo patch for a final 7 days.

Treatment:

Other: Transdermal placebo

Drug: Transdermal nicotine

Transdermal placebo first, nicotine last

Experimental group

Description:

Subject will receive transdermal placebo daily for 7 days, placebo patch for another 7 days, then transdermal nicotine 7 mg daily for a final 7 days.

Treatment:

Other: Transdermal placebo

Drug: Transdermal nicotine