A Phase 1 interventional study of Transdermal nicotine and Transdermal placebo in Autism Spectrum Disorder, Aggression and Irritability, sponsored by Yale University. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2022-05-06.
Sponsored by Yale University · Phase 1, Interventional, and Treatment
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.
1,344 studies on the registry are indexed under Autistic Disorder; 334 are open to participants now.
This study's enrollment of 8 is below the median of 45 across 1,044 interventional studies indexed under Autistic Disorder.
Browse Autistic Disorder studies →Yale University is the lead sponsor of 1,724 studies on the registry; 298 are open to participants now.
Of its 210 completed or terminated interventional studies of FDA-regulated products, 126 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria:
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 nicotine · Other: Transdermal placebo
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 nicotine · Other: Transdermal placebo
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.
Time frame: Baseline and 7 days.
Change in Social Responsiveness Scale-Adults (SRS-A)
The Social Responsiveness Scale (SRS) - 2 quantifies impairments in social behaviors seen in autism spectrum disorder and related conditions and their severity. The version used in this study is completed by parents/caregivers. The raw score range is 0 (unaffected) to \> 134 (extremely affected). The ABC is completed by parents/caregivers.
Time frame: Baseline and 7 days.
Change in Qualitative Description of Irritability and Aggression Symptoms
Brief qualitative reports of the patient's subjective experience will be recorded by asking "In what ways did you find the patch helpful or harmful during the past week, if at all?".
Time frame: Baseline and 7 days
Change in Frustration and Irritability Ratings During Frustration-induction Go-NoGo Task
Subjects will perform a computerized frustration-induction task and complete a rating scale of irritability and frustration levels.
Time frame: Baseline and one week
Change in State/Trait Anxiety Inventory (STAI) Score
The State-Trait Anxiety Inventory (STAI) is a measure of trait and state anxiety. It ranges from a score of 20 (least affected) to 80 (most affected).
Time frame: Baseline and day 7
Nightly Sleep Quality
Caregivers rated nightly sleep quality from 0 (worst) to 10 (best). Average rating for each treatment week is compared.
Time frame: Day 7
| Milestone | Transdermal Placebo First, Nicotine Last | Transdermal Nicotine First, Placebo Last |
|---|---|---|
| Started | 4 | 4 |
| Completed | 3 | 4 |
| Not completed | 1 | 0 |
| Withdrew: Protocol violation | 1 | 0 |
| Milestone | Transdermal Placebo First, Nicotine Last | Transdermal Nicotine First, Placebo Last |
|---|---|---|
| Started | 3 | 4 |
| Completed | 3 | 4 |
| Not completed | 0 | 0 |
| Milestone | Transdermal Placebo First, Nicotine Last | Transdermal Nicotine First, Placebo Last |
|---|---|---|
| Started | 3 | 4 |
| Completed | 1 | 4 |
| Not completed | 2 | 0 |
| Withdrew: Protocol violation | 2 | 0 |
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.
| units on a scale | Nicotine | Placebo |
|---|---|---|
| Change From Baseline in Aberrant Behavior Checklist Irritability Subscale (ABC-I) | -12 ± 3 | -7 ± 8 |
The Social Responsiveness Scale (SRS) - 2 quantifies impairments in social behaviors seen in autism spectrum disorder and related conditions and their severity. The version used in this study is completed by parents/caregivers. The raw score range is 0 (unaffected) to \> 134 (extremely affected). The ABC is completed by parents/caregivers.
| units on a scale | Nicotine | Placebo |
|---|---|---|
| Change in Social Responsiveness Scale-Adults (SRS-A) | -1 ± 25 | -15 ± 23 |
Brief qualitative reports of the patient's subjective experience will be recorded by asking "In what ways did you find the patch helpful or harmful during the past week, if at all?".
No measurements were reported for this outcome.
Subjects will perform a computerized frustration-induction task and complete a rating scale of irritability and frustration levels.
No measurements were reported for this outcome.
The State-Trait Anxiety Inventory (STAI) is a measure of trait and state anxiety. It ranges from a score of 20 (least affected) to 80 (most affected).
No measurements were reported for this outcome.
Caregivers rated nightly sleep quality from 0 (worst) to 10 (best). Average rating for each treatment week is compared.
| units on a scale | Nicotine | Placebo |
|---|---|---|
| Nightly Sleep Quality | 10 ± 0.2 | 9 ± 2 |
Aberrant Behavior Checklist (ABC) measures symptom subscales for individuals with neurodevelopmental disorders. The ABC-lethargy/social withdrawal subscale measures lethargy/social withdrawal and related symptoms and the subscale score range is 0 (least symptomatic) to 48 (most symptomatic). The ABC is completed by parents/caregivers.
| units on a scale | Nicotine | Placebo |
|---|---|---|
| Aberrant Behavior Checklist - Lethargy/Social Withdrawal Subscale Change From Baseline | -2 ± 3 | -7 ± 4 |
Aberrant Behavior Checklist (ABC) measures symptom subscales for individuals with neurodevelopmental disorders. The ABC-stereotypic behavior subscale measures stereotypic behaviors and related symptoms and the subscale score range is 0 (least symptomatic) to 21 (most symptomatic). The ABC is completed by parents/caregivers.
| units on a scale | Nicotine | Placebo |
|---|---|---|
| Aberrant Behavior Checklist - Stereotypic Behavior Subscale Change From Baseline | -2 ± 3 | -4 ± 4 |
Aberrant Behavior Checklist (ABC) measures symptom subscales for individuals with neurodevelopmental disorders. The ABC-hyperactivity subscale measures hyperactivity and related symptoms and the subscale score range is 0 (least symptomatic) to 48 (most symptomatic). The ABC is completed by parents/caregivers.
| units on a scale | Nicotine | Placebo |
|---|---|---|
| Aberrant Behavior Checklist - Hyperactivity Subscale Change From Baseline | -7 ± 6 | -6 ± 6 |
Aberrant Behavior Checklist (ABC) measures symptom subscales for individuals with neurodevelopmental disorders. The ABC-Inappropriate speech subscale measures Inappropriate speech and related symptoms and the subscale score range is 0 (least symptomatic) to 12 (most symptomatic). The ABC is completed by parents/caregivers.
| units on a scale | Nicotine | Placebo |
|---|---|---|
| Aberrant Behavior Checklist - Inappropriate Speech Subscale Change From Baseline | -1 ± 2 | 0.2 ± 0.8 |
Caregivers asked which treatment week showed the greatest improvement in aggressive or irritable behavior
| Participants | Nicotine | Placebo |
|---|---|---|
| Global Aggressive Behavior Improvement | 4 | 2 |
Collected over Duration of trial (3 weeks).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Nicotine | 0/7 (0%) | 0/7 (0%) | 0/7 (0%) |
| Placebo | 0/7 (0%) | 0/7 (0%) | 1/7 (14.3%) |
| Event | Nicotine | Placebo |
|---|---|---|
| NightmareNervous system disorders | 0/7 | 1/7 |
| DyspepsiaGastrointestinal disorders | 0/7 | 1/7 |
One subject was enrolled and randomized but later determined to be ineligible for the study and not included in the baseline analysis population.
| Age, Continuous(years) | All Study Participants |
|---|---|
| Mean | 24 ± 3 |
| Sex: Female, Male(Participants) | All Study Participants |
|---|---|
| Female | 1 |
| Male | 6 |
| Race and Ethnicity Not Collected(Participants) | All Study Participants |
|---|
| Region of Enrollment(Participants) | All Study Participants |
|---|---|
| United States | 7 |
| Aberrant Behavior Checklist-Irritability(units on a scale) | All Study Participants |
|---|---|
| Mean | 25 ± 8 |
| Aberrant Behavior Checklist-Lethargy/Social withdrawal(units on a scale) | All Study Participants |
|---|---|
| Mean | 20 ± 13 |
| Aberrant Behavior Checklist-Stereotypic behavior(units on a scale) | All Study Participants |
|---|---|
| Mean | 9 ± 7 |
| Aberrant Behavior Checklist-Hyperactivity(units on a scale) | All Study Participants |
|---|---|
| Mean | 26 ± 11 |
3 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
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Yale University