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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
Study Summary
This study is evaluating whether disulfiram may help individuals with post-treatment Lyme disease symptoms.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Fatigue Severity Scale (FSS)
Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF)
Secondary outcome measures
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 moreTrial 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
20,907 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
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who else is applying?
What state do they live in?
Wisconsin
New York
How old are they?
18 - 65
65+
What site did they apply to?
Lyme Research Center New York State Psychiatric Institute
What portion of applicants met pre-screening criteria?
Met criteria
How responsive is this trial?
Typically responds via
Email
Most responsive sites:
- Lyme Research Center New York State Psychiatric Institute: < 24 hours
Average response time
- < 1 Day
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