Trial · NCT03891667
Disulfiram: A Test of Symptom Reduction Among Patients With Previously Treated Lyme Disease
NCT03891667, Phase 1, Phase 2, Completed, Research Foundation for Mental Hygiene, Inc.; results first posted 2023-06-05
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Disulfiram: A Test of Symptom Reduction Among Patients With Previously Treated Lyme Disease. Trials, record NCT03891667. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03891667
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Disulfiram: A Test of Symptom Reduction Among Patients With Previously Treated Lyme Disease
- NCT number
- NCT03891667
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 11 participants, actual
- Lead sponsor
- Research Foundation for Mental Hygiene, Inc.
- Conditions
- Fatigue, Quality of Life
- Interventions
- Disulfiram
- First posted
- 2019-03-27
- Last updated
- 2025-01-09
- Results first posted
- 2023-06-05
- Limitations and caveats
This study did not reach its goal of 24 participants largely due to the impact of the COVID-19 pandemic on the ability to recruit subjects. Our small sample limits the conclusions that can be drawn from this trial, but the findings will be helpful to inform future studies.
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Fatigue Severity Scale (FSS) | Change will be assessed over a 10 week interval | This is a psychometrically validated self-report measure of fatigue. This measure consists of 11 items inquiring about the severity of fatigue in different situations during the past week. Scores for each item range from 1 to 7, where 1 indicates strong disagreement and 7 strong agreement. Higher scores indicate higher levels of fatigue. A responder on the FSS is an individual whose FSS total score has decreased by 0.7 its when compared baseline to week 10 (or last observation carried forward); 0.7 refers to the minimally clinical significant difference (MCID) in change over time. We report the number of participants who reached a meaningful reduction in fatigue (equal or more than MCID). |
| Primary | Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) | Change will be assessed over a 10 week interval | The Q-LES-Q - SF is a self-reported questionnaire, with 16 items evaluating overall enjoyment and satisfaction with physical health, mood, work, household and leisure activities, social and family relationships, daily functioning, sexual life, economic status, overall well-being and medications. Responses are scored on a 5-point scale, where higher scores indicate better enjoyment and satisfaction with life (possible range 14-70). Fourteen summated items create the total Q-LES-Q - SF score. Two last items, about medications and overall life satisfaction, are considered independently. Meaningful improvement on the Q-LES-Q to is a change score between baseline and week 10 (or last observation carried forward) of at least 6.8 points; 6.8 refers to the minimally clinical significant difference (MCID) where a score equal to or greater than 6.8 points represents an improved quality of file. We report # with meaningful improvement. |
| Secondary | The Short Form (36) Health Survey (SF-36) Physical Component Summary (PCS) | Change will be assessed over a 10 week interval | The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. The 8 scales are-vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning mental health. Each scale is directly transformed into a 0-100 scale, the lower the score the more disability and the higher the score the less disability. We calculate the Physical Component Summary (PCS) (representing physical functioning) which represent the items in the SF-36 representing physical functioning (Ware, 2000); as in the sub scales, lower scores indicate greater disability.The norm-based estimate has a mean of 50 and a standard deviation of 10. We report the magnitude of the score change from baseline to week 10 (or the last observation carried forward (LOCF); negative change scores indicate improvement. |
| Secondary | General Symptom Questionnaire (GSQ-30)- Assess Multisystemic Symptom Burden | Change will be assessed over a 10 week interval | This is a psychometrically validated 30 item self-report measure of symptom burden. The measure asks participants to rate how bothered they have been with a particular symptom over a 2-week time frame. Responses are made on 5-point Likert scale ranging from "not at all" to "very much" (scored 0-4); and the total score ranges from 0-120. Higher scores indicate more symptom severity. We report the magnitude of the score change (week 10 or last observation carried forward (LOCF)) minus the baseline score; a positive change score indicates improvement. |
| Secondary | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Symptom Summary Score on Sleep Disturbance, Pain, Anxiety, Depression, and Low Energy/Fatigue (SPADE) | Change will be assessed over a 10 week interval | The PROMIS-29 is a psychometrically validated 29 item self-report measure covering 7 domains. The questions are ranked on a 5-point Likert Scale. The composite score on 5 symptoms of the 7 domains is known as the SPADE summary score (sleep disturbance, pain, anxiety, depression, and low energy/fatigue); this represents the most common chronic symptoms in the general population. Each domain has 5 response options (e.g., 1=not at all to 5=very much), with scale scores ranging from 4 to 20 and higher scores indicating worse symptom severity. Using the scores from these 5 domains, we calculated the average score (SPADE score); the SPADE score ranges from 1 to 5 with higher scores indicating more symptom severity. We report the magnitude of the change in SPADE scores from baseline to week 10 (or the last observation carried forward (LOCF)); a positive change score indicates improvement. |
| Secondary | The Short Form (36) Health Survey (SF-36) Mental Component Summary (MCS) | Change will be assessed over a 10 week interval | The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. The 8 scales are-vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning mental health. Each scale is directly transformed into a 0-100 scale, the lower the score the more disability and the higher the score the less disability. We calculate the Mental Component Summary (MCS) (representing physical functioning) which represent the items in the SF-36 representing physical functioning (Ware, 2000); as in the sub scales, lower scores indicate greater disability.. The norm-based estimate mean is 50 with a standard deviation of 10. We report the magnitude of the change in scores from baseline to week 10 (or the last observation carried forward (LOCF)); a negative change score indicates improvement. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Fatigue Severity Scale (FSS) | Change will be assessed over a 10 week interval | We conduct an intent to treat analysis which covers all enrolled and randomized patients who received study drug. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) | Change will be assessed over a 10 week interval | We conduct an intent to treat analysis which covers all enrolled and randomized patients who received study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | The Short Form (36) Health Survey (SF-36) Physical Component Summary (PCS) | Change will be assessed over a 10 week interval | We conduct an intent to treat analysis which covers all enrolled patients who received study drug. | Score on scale (baseline minus LOCF) | MEAN |
| SECONDARY | General Symptom Questionnaire (GSQ-30)- Assess Multisystemic Symptom Burden | Change will be assessed over a 10 week interval | We conduct an intent to treat analysis which covers all enrolled and randomized patients who received study drug. | change in score (baseline minus LOCF) | MEAN |
| SECONDARY | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Symptom Summary Score on Sleep Disturbance, Pain, Anxiety, Depression, and Low Energy/Fatigue (SPADE) | Change will be assessed over a 10 week interval | We conduct an intent to treat analysis which covers all enrolled and randomized patients who received study drug. | Score on scale (baseline minus LOCF) | MEAN |
| SECONDARY | The Short Form (36) Health Survey (SF-36) Mental Component Summary (MCS) | Change will be assessed over a 10 week interval | We conduct an intent to treat analysis which covers all enrolled and randomized patients who received study drug. | Score on scale (baseline minus LOCF) | MEAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Fatigue Severity Scale (FSS) | 8 Week Disulfiram | 4 | Participants | ||
| Fatigue Severity Scale (FSS) | 4 Week Disulfiram | 2 | Participants | ||
| Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) | 8 Week Disulfiram | 2 | Participants | ||
| Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) | 4 Week Disulfiram | 2 | Participants | ||
| The Short Form (36) Health Survey (SF-36) Physical Component Summary (PCS) | 8 Week Disulfiram | -5.183 | Standard Deviation 4.126 | Score on scale (baseline minus LOCF) | |
| The Short Form (36) Health Survey (SF-36) Physical Component Summary (PCS) | 4 Week Disulfiram | -6.466 | Standard Deviation 5.374 | Score on scale (baseline minus LOCF) | |
| General Symptom Questionnaire (GSQ-30)- Assess Multisystemic Symptom Burden | 8 Week Disulfiram | 25.6 | Standard Deviation 12.402 | change in score (baseline minus LOCF) | |
| General Symptom Questionnaire (GSQ-30)- Assess Multisystemic Symptom Burden | 4 Week Disulfiram | 6.25 | Standard Deviation 20.790 | change in score (baseline minus LOCF) | |
| Patient-Reported Outcomes Measurement Information System (PROMIS-29) Symptom Summary Score on Sleep Disturbance, Pain, Anxiety, Depression, and Low Energy/Fatigue (SPADE) | 8 Week Disulfiram | 6.86 | Standard Deviation 3.71 | Score on scale (baseline minus LOCF) | |
| Patient-Reported Outcomes Measurement Information System (PROMIS-29) Symptom Summary Score on Sleep Disturbance, Pain, Anxiety, Depression, and Low Energy/Fatigue (SPADE) | 4 Week Disulfiram | 5.95 | Standard Deviation 5.15 | Score on scale (baseline minus LOCF) |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 8 Week Disulfiram | 6 | |
| Overall Study | STARTED | 4 Week Disulfiram | 5 | |
| Overall Study | Start of the Medication | 8 Week Disulfiram | 5 | |
| Overall Study | Start of the Medication | 4 Week Disulfiram | 4 | |
| Overall Study | Completed All 8 Weeks of Drug Treatment | 8 Week Disulfiram | 1 | |
| Overall Study | Completed All 8 Weeks of Drug Treatment | 4 Week Disulfiram | 2 | |
| Overall Study | Completed All 10 Weeks of Assessments | 8 Week Disulfiram | 4 | |
| Overall Study | Completed All 10 Weeks of Assessments | 4 Week Disulfiram | 2 | |
| Overall Study | COMPLETED | 8 Week Disulfiram | 4 | |
| Overall Study | COMPLETED | 4 Week Disulfiram | 2 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events26
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Mild-moderately elevated liver function tests | Hepatobiliary disorders | 8 Week Disulfiram | 3 | 5 | 3 |
| other | Mild-moderately elevated liver function tests | Hepatobiliary disorders | 4 Week Disulfiram | 0 | 4 | 0 |
| other | Mildly elevated serum creatinine | Renal and urinary disorders | 8 Week Disulfiram | 1 | 5 | 1 |
| other | Mildly elevated serum creatinine | Renal and urinary disorders | 4 Week Disulfiram | 0 | 4 | 0 |
| other | Moderate headache | General disorders | 8 Week Disulfiram | 1 | 5 | 1 |
| other | Moderate headache | General disorders | 4 Week Disulfiram | 0 | 4 | 0 |
| other | Moderate to severe sore throat/throat hoarseness | General disorders | 8 Week Disulfiram | 2 | 5 | 2 |
| other | Moderate to severe sore throat/throat hoarseness | General disorders | 4 Week Disulfiram | 0 | 4 | 0 |
| other | Moderate to severe hypersomnia/sleepiness | General disorders | 8 Week Disulfiram | 2 | 5 | 2 |
| other | Moderate to severe hypersomnia/sleepiness | General disorders | 4 Week Disulfiram | 0 | 4 | 0 |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 8 Week Disulfiram | 0 | 5 |
| Total, all-cause mortality | 4 Week Disulfiram | 0 | 4 |
| Total, other adverse events | 8 Week Disulfiram | 5 | 5 |
| Total, other adverse events | 4 Week Disulfiram | 1 | 4 |
| Total, serious adverse events | 8 Week Disulfiram | 1 | 5 |
| Total, serious adverse events | 4 Week Disulfiram | 1 | 4 |
Source ClinicalTrials.gov
Papers5
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| 8 Week Disulfiram vs 4 Week Disulfiram: Fatigue Severity Scale (FSS) | Trial comparisons |
| 8 Week Disulfiram vs 4 Week Disulfiram: Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) | Trial comparisons |
| 8 Week Disulfiram vs 4 Week Disulfiram: deaths from any cause | Trial comparisons |
| 8 Week Disulfiram vs 4 Week Disulfiram: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03891667
GET https://conductscience.org/api/trials/v1/NCT03891667/events?page=2