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NCT01721330 · ClinicalTrials.gov registry record · Phase 4
A Double-Blind Comparison of Naltrexone and Placebo in Adults With Attention Deficit Hyperactivity Disorder
A Phase 4 study, sponsored by Massachusetts General Hospital.
- Terminated
- Registry status
- Phase 4
- Development phase
- 3
- Enrollment target
NCT01721330: Clinical Trial Phase 4 study, sponsored by Massachusetts General Hospital.
NCT01721330 is a Phase 4 study that was terminated before completion, 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.
The verdict
NCT01721330, a Phase 4 study, was terminated before completion, sponsored by Massachusetts General Hospital.
- TERMINATED
- 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 ADHD in adults. Medications that increase dopamine are often effective treatments for ADHD. Since naltrexone is a kappa opioid receptor antagonist, it increases dopamine in the brain. The investigators predict that naltrexone as a monotherapy will be effective for ADHD symptoms in adults with ADHD. The investigators also plan to assess the effects of naltrexone on dopamine as measured by changes in serum prolactin. The investigators predict that naltrexone will increase dopamine as indexed by decreases in serum prolactin. This study will be a six-week, double-blind, placebo-controlled pilot study with adults 18-55 years of age with ADHD.
Primary Outcome
The 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). We measured the change in AISRS score from baseline to week 6.
Interventions
- DRUG Placebo
- DRUG Naltrexone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2012-11 |
| Est. Completion | 2015-02 |
| Phase | Phase 4 |
Why NCT01721330 stopped before completion
NCT01721330 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 2 interventions - of which Placebo is the first listed.
NCT01721330 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01721330 about?
NCT01721330 is a clinical study titled "A Double-Blind Comparison of Naltrexone and Placebo 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 ADHD in adults. Medications that increase dopamine are often effective treatments for ADHD. Since naltrexone is a kappa opioid receptor antagonist, it increases dopamine in the brain. The investig...
What is the current status of trial NCT01721330?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 3 participants. The study started on 2012-11. Estimated completion is 2015-02.
What interventions are being tested in trial NCT01721330?
The interventions under investigation include: Placebo (DRUG), Naltrexone (DRUG).
Who is sponsoring clinical trial NCT01721330?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01721330'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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