Disulfiram: A Test of Symptom Reduction Among Patients With Previously Treated Lyme Disease

• Status: Recruiting
• Trial end date: 2022-03-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Research Foundation for Mental Hygiene, Inc.
• Collaborator: FDC Foundation
• Treatments: Disulfiram

Criteria

Inclusion Criteria:

• History of Lyme Disease diagnosis within the prior 16 years History of prior diagnosis of Lyme disease that met the Centers for Disease Control (CDC) surveillance criteria case definition

• For erythema migrans (EM) rash, this has to be health-care provider diagnosed;

• For later stages of Lyme disease, this requires a diagnosis of LD by a health-care provider and laboratory testing that confirms a positive result historically.

• History of treatment for Lyme disease that consists of at least 5 weeks of antibiotics (total adding all treatment courses) within the last 16 years.

• Partial Prior Response. History of at least partial response to prior antibiotic therapy for Lyme disease.

• Antibiotic-free interval. Willingness to be off of other antibiotics during the course of this study and for at least 3 months prior to study randomization and during the 14 weeks of this study.

• Current moderate to severe fatigue. The following criteria need to be met:

1. at least moderate intensity at study screening and at intake (a score of 4 or more on the Fatigue Severity Scale)

2. triggered or perpetuated by Lyme disease and persisting for at least 6 months after treatment

3. is not better attributed to another independent medical or psychiatric condition

4. current episode of Lyme disease-related fatigue is relatively persistent and has not had an intervening interval of 8 months without fatigue since diagnosis of Lyme disease.

• Current post-Lyme symptoms impair the patient's quality of life

• Keeping other current treatments stable- Patients can stay on other non-antibiotic medications as long as these medications have been stable for the 3 months prior to study onset and the dosage regimen does not change during the course of this study (unless the latter is medically or psychiatrically indicated).

• Between the ages 18-65

• Ability to read and speak English

Exclusion Criteria:

• History of cardiovascular disease (e.g., coronary artery disease or heart failure).

• History of seizure disorder, abnormal EEGs, traumatic brain injury, renal disease (e.g. nephritis), liver disease (e.g., hepatitis, CIRRHOSIS), diabetes mellitus, hypothyroidism and/or psychosis. Patients with a history of large fiber neuropathy (EMG/NCS documented) will also be excluded.

• History of Substance Use Disorder (e.g., alcohol abuse, multi-drug dependence) within the past 2 years

• History in the last 6 months of heavy alcohol use which is defined as binge drinking more than 5 days in a one-month period. A binge-drinking episode refers to the consumption of 5 or more drinks for men or 4 or more drinks for women in a 2-hour period.

• Evidence of current active tick-borne illness other than Lyme disease. (Note: patients with evidence of positive antibodies for another TBI will be eligible unless there is evidence that this other TBI is currently active (eg., elevated LFTS (AST & ALT not greater than 2 times upper limit), low platelets, low WBC, high fevers)

• Unwillingness to confirm that he/she will abstain from alcohol and products that may contain alcohol (including sauces, cough syrup, vinegar, backrub products, aftershave lotions) during the month prior to randomization, during the course of this study, and for 6 weeks after the last dose of study medication.

• Inability to confirm abstinence from cannabis or CBD or THC-containing products

• Women who are breastfeeding, pregnant, or at risk of becoming pregnant during the course of the study.

• Patients who are taking or plan to take warfarin, metronidazole, paraldehyde, phenytoin, theophylline, oral anticoagulants, or isoniazid

• A concurrent or recent illness that may better account for current fatigue

• Unwillingness to not take any new non-emergency medications during the course of this study without first reviewing with the study research physician

• History of rubber-contact dermatitis or allergy to disulfiram or thiuram derivatives

• Prior history of serious adverse reaction to disulfiram

• Cognitive Impairment for patients over 60.

• Suicidal acts in the last 6 months or current suicidal thoughts with intent or plan or history of bipolar disorder.