NCT02552147

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Sep 2015

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

September 14, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 16, 2015

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 17, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 17, 2017

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

March 14, 2019

Completed
Last Updated

May 6, 2022

Status Verified

May 1, 2022

Enrollment Period

2.2 years

First QC Date

September 14, 2015

Results QC Date

March 9, 2018

Last Update Submit

May 4, 2022

Conditions

Autism Spectrum DisorderAggressionIrritability

Keywords

Autism spectrum disorderAggressionIrritabilityNicotineNicotinic acetylcholine receptorNicotinic agonistAdult autism

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in Aberrant Behavior Checklist Irritability Subscale (ABC-I)

    Aberrant Behavior Checklist (ABC) measures symptom subscales for individuals with neurodevelopmental disorders. The ABC-irritability subscale measures irritability and related symptoms and the subscale score range is 0 (least symptomatic) to 45 (most symptomatic). The ABC is completed by parents/caregivers.

    Baseline and 7 days.

Secondary Outcomes (5)

  • Change in Social Responsiveness Scale-Adults (SRS-A)

    Baseline and 7 days.

  • Change in Qualitative Description of Irritability and Aggression Symptoms

    Baseline and 7 days

  • Change in Frustration and Irritability Ratings During Frustration-induction Go-NoGo Task

    Baseline and one week

  • Change in State/Trait Anxiety Inventory (STAI) Score

    Baseline and day 7

  • Nightly Sleep Quality

    Day 7

Study Arms (2)

Transdermal nicotine first, placebo last

EXPERIMENTAL

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

Drug: Transdermal nicotineOther: Transdermal placebo

Transdermal placebo first, nicotine last

EXPERIMENTAL

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.

Drug: Transdermal nicotineOther: Transdermal placebo

Interventions

Transdermal nicotineDRUG
Transdermal nicotine first, placebo lastTransdermal placebo first, nicotine last
Transdermal placeboOTHER
Transdermal nicotine first, placebo lastTransdermal placebo first, nicotine last

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale University

New Haven, Connecticut, 06511, United States

Location

Related Publications (1)

  • 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.

    PMID: 37811711DERIVED

MeSH Terms

Conditions

Autism Spectrum DisorderAggressionAutistic Disorder

Interventions

Tobacco Use Cessation Devices

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental DisordersAberrant Motor Behavior in DementiaBehavioral SymptomsBehaviorSocial Behavior

Intervention Hierarchy (Ancestors)

Therapeutics

Limitations and Caveats

Unable to recruit the pre-specified number of subjects; Subjects were unable to reliably complete personal ratings (STAI and STAXI) and were unable to reliably complete the frustrative computer task.

Results Point of Contact

Title
Alan Lewis, MD, PhD
Organization
Vanderbilt University Medical Center
alan.s.lewis@vumc.org
(615) 936-4997

Study Officials

  • Alan S Lewis, MD, PhD

    Lecturer in psychiatry

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2015

First Posted

September 16, 2015

Study Start

September 1, 2015

Primary Completion

November 17, 2017

Study Completion

November 17, 2017

Last Updated

May 6, 2022

Results First Posted

March 14, 2019

Record last verified: 2022-05

Locations

US(1)