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| Name | Class |
|---|---|
| Autism Speaks | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transdermal nicotine | Drug |
| ||
| Transdermal placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 7 days. |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alan S Lewis, MD, PhD | Lecturer in psychiatry | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University | New Haven | Connecticut | 06511 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37811711 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. Transdermal nicotine Transdermal placebo |
| FG001 | 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. Transdermal nicotine Transdermal placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (7 Days) |
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| ||||||||||||||||||
| Washout (7 Days) |
| |||||||||||||||||||
| Second Intervention (7 Days) |
|
One subject was enrolled and randomized but later determined to be ineligible for the study and not included in the baseline analysis population.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | Participants randomized to receive either transdermal nicotine or placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | All participants who completing all study visits and for which ratings scales were completed in accordance with study protocol. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 7 days. |
|
Duration of trial (3 weeks).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Nicotine | Subject receiving transdermal nicotine in either the first or last week of the study and completing all study visits. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nightmare | Nervous system disorders | Non-systematic Assessment |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alan Lewis, MD, PhD | Vanderbilt University Medical Center | (615) 936-4997 | alan.s.lewis@vumc.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 29, 2017 | Nov 23, 2018 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 29, 2017 | Nov 29, 2017 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D000374 | Aggression |
| D001321 | Autistic Disorder |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D000096762 | Aberrant Motor Behavior in Dementia |
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| ID | Term |
|---|---|
| D061485 | Tobacco Use Cessation Devices |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Other |
|
| 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?". | 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. | 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). | 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. | Day 7 |
| NOT COMPLETED |
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| NOT COMPLETED |
|
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Aberrant Behavior Checklist-Irritability | 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. | Mean | Standard Deviation | units on a scale |
|
| Aberrant Behavior Checklist-Lethargy/Social withdrawal | 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. | Mean | Standard Deviation | units on a scale |
|
| Aberrant Behavior Checklist-Stereotypic behavior | 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. | Mean | Standard Deviation | units on a scale |
|
| Aberrant Behavior Checklist-Hyperactivity | 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. | Mean | Standard Deviation | units on a scale |
|
| Aberrant Behavior Checklist-Inappropriate speech | 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. | Mean | Standard Deviation | units on a scale |
|
| Social Responsiveness Scale-2 | 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. | Mean | Standard Deviation | units on a scale |
|
| Number on antipsychotic medication | Count of Participants | Participants |
|
| Placebo |
Subject receiving transdermal placebo in either the first or last week of the study and completing all study visits. |
|
|
|
| Secondary | 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. | All participants completing all study visits and for which ratings scales were completed in accordance with study protocol. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 7 days. |
|
|
|
|
| Secondary | 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?". | Data were not collected. | Posted | Baseline and 7 days |
|
|
| Secondary | 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. | Data were not collected. | Posted | Baseline and one week |
|
|
| Secondary | 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). | Data were not collected. | Posted | Baseline and day 7 |
|
|
| Secondary | Nightly Sleep Quality | Caregivers rated nightly sleep quality from 0 (worst) to 10 (best). Average rating for each treatment week is compared. | Posted | Mean | Standard Deviation | units on a scale | Day 7 |
|
|
|
|
| Post-Hoc | Aberrant Behavior Checklist - Lethargy/Social Withdrawal Subscale Change From Baseline | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 7 days |
|
|
|
|
| Post-Hoc | Aberrant Behavior Checklist - Stereotypic Behavior Subscale Change From Baseline | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 7 days |
|
|
|
|
| Post-Hoc | Aberrant Behavior Checklist - Hyperactivity Subscale Change From Baseline | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 7 days |
|
|
|
|
| Post-Hoc | Aberrant Behavior Checklist - Inappropriate Speech Subscale Change From Baseline | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 7 days |
|
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|
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| Post-Hoc | Global Aggressive Behavior Improvement | Caregivers asked which treatment week showed the greatest improvement in aggressive or irritable behavior | Posted | Count of Participants | Participants | Baseline and 7 days |
|
|
|
|
| 0 |
| 7 |
| 0 |
| 7 |
| 0 |
| 7 |
| EG001 | Placebo | Subject receiving transdermal placebo in either the first or last week of the study and completing all study visits. | 0 | 7 | 0 | 7 | 1 | 7 |
| Dyspepsia | Gastrointestinal disorders | Non-systematic Assessment |
|
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| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D012919 | Social Behavior |