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NCT03891667 · ClinicalTrials.gov registry record · Phase 1
Disulfiram: A Test of Symptom Reduction Among Patients With Previously Treated Lyme Disease
A Phase 1 study, sponsored by Research Foundation for Mental Hygiene.
- Completed
- Registry status
- Phase 1
- Development phase
- 11
- Enrollment target
NCT03891667: Completed Phase 1 study, sponsored by Research Foundation for Mental Hygiene.
NCT03891667 is a Phase 1 study that has completed, run by Research Foundation for Mental Hygiene. The registered enrollment target is 11 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03891667, a Phase 1 study, has completed, sponsored by Research Foundation for Mental Hygiene.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 11 participants
- Enrollment target
Study Summary
Approximately 10-20% of patients experience ongoing symptoms despite having received standard antibiotic therapy for Lyme disease. Possible explanations for persistent symptoms include persistent infection and/or post-infectious causes. Recent in vitro studies indicate that disulfiram is effective at killing both the actively replicating and the more quiescent persister forms of Borrelia burgdorferi, the microbe that causes Lyme Disease. In this study, the investigators are examining the safety of disulfiram among patients with post-treatment Lyme disease symptoms. The investigators are also conducting a preliminary investigation regarding the relative benefit of 4 vs 8 weeks of treatment with disulfiram.
Primary Outcome
This is a psychometrically validated self-report measure of fatigue. This measure consists of 11 items inquiring about the severity of fatigue in different situations during the past week. Scores for each item range from 1 to 7, where 1 indicates strong disagreement and 7 strong agreement. Higher scores indicate higher levels of fatigue. A responder on the FSS is an individual whose FSS total score has decreased by 0.7 its when compared baseline to week 10 (or last observation carried forward);
Interventions
- DRUG Disulfiram
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2019-07-31 |
| Est. Completion | 2022-03-31 |
| Phase | Phase 1 |
What the finished NCT03891667 record still lists
NCT03891667 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (82% lower).
The record links to 0 conditions, and to 1 intervention - of which Disulfiram is the first listed.
NCT03891667 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03891667 about?
NCT03891667 is a clinical study titled "Disulfiram: A Test of Symptom Reduction Among Patients With Previously Treated Lyme Disease". Approximately 10-20% of patients experience ongoing symptoms despite having received standard antibiotic therapy for Lyme disease. Possible explanations for persistent symptoms include persistent infection and/or post-infectious causes. Recent in vitro studies indicate that disulfiram is effective a...
What is the current status of trial NCT03891667?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 11 participants. The study started on 2019-07-31. Estimated completion is 2022-03-31.
What interventions are being tested in trial NCT03891667?
The interventions under investigation include: Disulfiram (DRUG).
Who is sponsoring clinical trial NCT03891667?
This trial is sponsored by Research Foundation for Mental Hygiene, which has 27 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03891667's enrollment target sits among peer trials
11 1911th of 2000 higher than 88 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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