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

Phase 1 & 2

Waitlist Available

Led By Brian A Fallon, MD

Research Sponsored by Research Foundation for Mental Hygiene, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change will be assessed over a 10 week interval

Awards & highlights

No Placebo-Only Group

Summary

This trial tests disulfiram, a drug usually used to help people stop drinking alcohol, for treating long-lasting Lyme disease symptoms. It focuses on patients who still have symptoms after standard antibiotics. Disulfiram can kill both active and dormant Lyme bacteria. The study will check the safety and effectiveness of different treatment periods.

Eligible Conditions

Quality of Life
Fatigue

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change will be assessed over a 10 week interval

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change will be assessed over a 10 week interval

This trial's timeline: 3 weeks for screening, Varies for treatment, and change will be assessed over a 10 week interval for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Fatigue Severity Scale (FSS)

Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF)

Secondary study objectives

General Symptom Questionnaire (GSQ-30)- Assess Multisystemic Symptom Burden

Patient-Reported Outcomes Measurement Information System (PROMIS-29) Symptom Summary Score on Sleep Disturbance, Pain, Anxiety, Depression, and Low Energy/Fatigue (SPADE)

The Short Form (36) Health Survey (SF-36) Mental Component Summary (MCS)

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: 8 Week DisulfiramExperimental Treatment1 Intervention

Patients in this group receive disulfiram for 8 weeks. The dosing schedule is fixed-flexible, starting at 250 mg every other day at week 1, 250 mg daily for week 2, 250 mg alternating with 500 mg for week 3, and 500 mg daily for week 4 to week 8. Dose increases are based on clinical judgment guided by patient tolerance, response, body weight, and side effects.

Group II: 4 Week DisulfiramActive Control1 Intervention

Patients in this group receive disulfiram for 4 weeks followed by placebo capsules for 4 weeks. The dosing schedule is fixed-flexible, starting at 250 mg every other day at week 1, 250 mg daily for week 2, 250 mg alternating with 500 mg during week 3, and 500 mg daily during week 4. Placebo capsules are given during weeks 5-8. Dose increases are based on clinical judgment guided by patient tolerance, response, body weight, and side effects.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Disulfiram

2008

Completed Phase 4

~1330

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