drugset / Trial / NCT03891667
Disulfiram: A Test of Symptom Reduction Among Patients With Previously Treated Lyme Disease
Phase 1/2
Completed
11 enrolled
Research Foundation for Mental Hygiene, Inc.
FDC Foundation · collab
RandomizedParallel-groupTriple-blindTreatment
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.
Timeline
- Start
- 2019-07-31
- Primary completion
- 2021-11-26
- Completion
- 2022-03-31
Publications
- Background Long TE. Repurposing Thiram and Disulfiram as Antibacterial Agents for Multidrug-Resistant Staphylococcus aureus Infections. Antimicrob Agents Chemother. 2017 Aug 24;61(9):e00898-17. doi: 10.1128/AAC.00898-17. Print 2017 Sep.
- Background Pothineni VR, Wagh D, Babar MM, Inayathullah M, Solow-Cordero D, Kim KM, Samineni AV, Parekh MB, Tayebi L, Rajadas J. Identification of new drug candidates against Borrelia burgdorferi using high-throughput screening. Drug Des Devel Ther. 2016 Apr 1;10:1307-22. doi: 10.2147/DDDT.S101486. eCollection 2016.
- Background Guerzoni S, Pellesi L, Pini LA, Caputo F. Drug-drug interactions in the treatment for alcohol use disorders: A comprehensive review. Pharmacol Res. 2018 Jul;133:65-76. doi: 10.1016/j.phrs.2018.04.024. Epub 2018 Apr 30.
- Background Liegner KB. Disulfiram (Tetraethylthiuram Disulfide) in the Treatment of Lyme Disease and Babesiosis: Report of Experience in Three Cases. Antibiotics (Basel). 2019 May 30;8(2):72. doi: 10.3390/antibiotics8020072.
- Kuvaldina M, Preston J, McClellan D, Pavlicova M, Brannagan TH, Fallon BA. A pilot study of disulfiram for individuals with persistent symptoms despite prior antibiotic treatment for Lyme disease. Front Med (Lausanne). 2025 Apr 2;12:1549324. doi: 10.3389/fmed.2025.1549324. eCollection 2025.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Disulfiram | Small molecule | 500 mg | — |
Indications
No indication recorded.