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NCT01873729 · ClinicalTrials.gov registry record · Phase 4

An Open-Label Study of Naltrexone in Adults With Attention Deficit Hyperactivity Disorder.

A Phase 4 study, sponsored by Massachusetts General Hospital.

Completed
Registry status
Phase 4
Development phase
3
Enrollment target

NCT01873729: Completed Phase 4 study, sponsored by Massachusetts General Hospital.

NCT01873729 is a Phase 4 study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 3 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

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The verdict

NCT01873729, a Phase 4 study, has completed, sponsored by Massachusetts General Hospital.

COMPLETED
Registry status
Phase 4
Development phase
3 participants
Enrollment target

Study Summary

The primary aim of this study is to assess whether naltrexone as a monotherapy is effective in treating Attention Deficit Hyperactivity Disorder (ADHD) in adults. Medications that increase dopamine are often effective in treating ADHD in adults. Since naltrexone is a kappa opioid receptor antagonist, it increases dopamine in the brain. We predict that naltrexone as a monotherapy will be effective for ADHD symptoms in adults with ADHD.

Primary Outcome

The Adult Investigator Symptom Rating Scale (AISRS) is an 18-item clinician rating scale to evaluate individual ADHD symptoms on a scale of 0 (none) to 3 (severe). The total sum ranges from 0 (no ADHD symptoms) to 54 (extremely severe ADHD symptoms).

Interventions

  • DRUG Naltrexone

Trial Details

FieldValue
Enrollment Target 3 participants
Start Date 2013-11
Est. Completion 2016-06
Phase Phase 4
Massachusetts General Hospital

2,032 total trials

What the finished NCT01873729 record still lists

NCT01873729 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower).

The record links to 0 conditions, and to 1 intervention - of which Naltrexone is the first listed.

NCT01873729 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01873729 about?

NCT01873729 is a clinical study titled "An Open-Label Study of Naltrexone in Adults With Attention Deficit Hyperactivity Disorder.". The primary aim of this study is to assess whether naltrexone as a monotherapy is effective in treating Attention Deficit Hyperactivity Disorder (ADHD) in adults. Medications that increase dopamine are often effective in treating ADHD in adults. Since naltrexone is a kappa opioid receptor antagonist...

What is the current status of trial NCT01873729?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 3 participants. The study started on 2013-11. Estimated completion is 2016-06.

What interventions are being tested in trial NCT01873729?

The interventions under investigation include: Naltrexone (DRUG).

Who is sponsoring clinical trial NCT01873729?

This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01873729's enrollment target sits among peer trials

3 1995th of 2000 higher than 3 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 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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Source: ClinicalTrials.gov NCT01873729, the US trial registry maintained by the National Library of Medicine. NCT01873729 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.