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

NCT ID: NCT02552147

Last Updated: 2022-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2017-11-17

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.

Conditions

Autism Spectrum Disorder; Aggression; Irritability

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Transdermal nicotine first, placebo last

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

Group Type: EXPERIMENTAL

Transdermal nicotine

Intervention Type: DRUG

Transdermal placebo

Intervention Type: OTHER

Transdermal placebo first, nicotine last

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.

Group Type: EXPERIMENTAL

Transdermal nicotine

Intervention Type: DRUG

Transdermal placebo

Intervention Type: OTHER

Interventions

Transdermal nicotine

Intervention Type: DRUG

Transdermal placebo

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Autism Speaks

OTHER

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alan S Lewis, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Lecturer in psychiatry

Locations

Yale University

New Haven, Connecticut, United States

Countries

United States

References

Iffland M, Livingstone N, Jorgensen M, Hazell P, Gillies D. Pharmacological intervention for irritability, aggression, and self-injury in autism spectrum disorder (ASD). Cochrane Database Syst Rev. 2023 Oct 9;10(10):CD011769. doi: 10.1002/14651858.CD011769.pub2.

Reference Type: DERIVED

PMID: 37811711 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

1502015384

Identifier Type: -

Identifier Source: org_study_id