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NCT02552147 · ClinicalTrials.gov registry record · Phase 1
Nicotinic Cholinergic Modulation as a Novel Treatment Strategy for Aggression Associated With Autism
A Phase 1 study, sponsored by Yale University.
- Completed
- Registry status
- Phase 1
- Development phase
- 8
- Enrollment target
NCT02552147: Completed Phase 1 study, sponsored by Yale University.
NCT02552147 is a Phase 1 study that has completed, run by Yale University. The registered enrollment target is 8 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02552147, a Phase 1 study, has completed, sponsored by Yale University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 8 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DRUG Transdermal nicotine
- OTHER Transdermal placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2015-09 |
| Est. Completion | 2017-11-17 |
| Phase | Phase 1 |
What the finished NCT02552147 record still lists
NCT02552147 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 2 interventions - of which Transdermal nicotine is the first listed.
NCT02552147 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02552147 about?
NCT02552147 is a clinical study titled "Nicotinic Cholinergic Modulation as a Novel Treatment Strategy for Aggression Associated With Autism". 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, pl...
What is the current status of trial NCT02552147?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2015-09. Estimated completion is 2017-11-17.
What interventions are being tested in trial NCT02552147?
The interventions under investigation include: Transdermal nicotine (DRUG), Transdermal placebo (OTHER).
Who is sponsoring clinical trial NCT02552147?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02552147's enrollment target sits among peer trials
8 1959th of 2000 higher than 29 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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