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Alcohol Deterrent

Disulfiram for Quality of Life

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

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 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

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
~1300

Find a Location

Who is running the clinical trial?

FDC FoundationOTHER
2 Previous Clinical Trials
Research Foundation for Mental Hygiene, Inc.Lead Sponsor
66 Previous Clinical Trials
20,899 Total Patients Enrolled
Brian A Fallon, MD1.03 ReviewsPrincipal Investigator - Columbia University
Research Foundation for Mental Hygiene, Inc.
4 Previous Clinical Trials
412 Total Patients Enrolled
~2 spots leftby Sep 2025
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