The Effect of Minocycline and N-acetylcysteine for the Treatment of Fibromyalgia

Study Purpose

Evaluation of the effect of combinatorial treatment of fibromyalgia patients (standard of care + minocycline + N-acetylcysteine (NAC) relative to standard of care on subjective pain measurement Revised Fibromyalgia Impact Questionnaire (FIQR).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender Female
More Inclusion & Exclusion Criteria

Inclusion Criteria.

  • - Female.
  • - Age 18 years or older.
  • - Diagnosis of fibromyalgia for at least 6 months (confirmed by the modified 2010 ACR Diagnostic Criteria for Fibromyalgia Widespread Pain Inventory and Symptom Severity Scale) - Currently on birth control or unable to become pregnant.
  • - Willingness to avoid taking opioid and opiate medications during the duration of the study (5-6 months) Exclusion Criteria.
  • - Known hypersensitivity to minocycline or tetracycline antibiotics or to N-acetylcysteine.
  • - Current opioid therapy or planned initiation of opioid therapy.
  • - Active pregnancy, lactation or plans to become pregnant in the next 6 months.
  • - Significant hepatic disease as indicated by an AST or ALT greater than twice the upper limits of normal or bilirubin greater than twice the upper limits of normal.
  • - Significant renal disease as indicated by an estimated glomerular filtration rate less than 60 mL/min/1.73m2 at baseline or during the first washout period.
  • - History of autoimmune syndromes (systemic lupus erythematosus, myasthenia gravis, rheumatoid arthritis, - History of intracranial hypertension or pseudotumor cerebri.
  • - History of IBD (Crohns disease, ulcerative colitis), Clostridium difficile infection.
  • - History of esophagitis, esophageal obstruction, achalasia or esophageal dysmotility.
  • - History of GI hemorrhage or known risk factors for GI hemorrhage, such as esophageal varices, peptic ulcer disease, etc. - Subjects taking divalent and trivalent cations such as oral iron supplements, certain dietary supplements (multivitamins) that contain manganese or zinc, or antacids that contain aluminum, calcium, or magnesium, which would decrease minocycline absorption.
  • - Subjects taking anticoagulant medication since minocycline can decrease plasma prothrombin activity.
  • - Subjects taking isotretinoin.
  • - Subject taking ergot alkaloids for migraines.
  • - Subjects taking penicillin antibiotics.
  • - Subjects taking methoxyflurane containing products.
  • - Subjects who work outdoors or otherwise have prolonged exposure to UV light and sunlight.
  • - Lack of access to reliable technology to be able to complete emailed REDCap questionnaires.
  • - Cognitive deficits that may make it difficult to adhere to the medication regimen or provide consistent and timely completion of questionnaires.
  • - Inability or unwillingness to give informed consent.
- Unwillingness to use two forms of birth control for the entire duration of participation in the study (if capable of becoming pregnant) - Unwillingness to complete home pregnancy tests throughout the study (if capable of becoming pregnant) - Inability to swallow large pills

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04594733
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1/Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Medical University of South Carolina
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Michael G Hillegass, MD
Principal Investigator Affiliation Medical University of South Carolina
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Enrolling by invitation
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Fibromyalgia
Arms & Interventions

Arms

Active Comparator: Placebo followed by minocycline (200 mg daily) and NAC (1200 mg daily)

Participants will be randomized to 8 weeks of placebo, minimum 2 week washout period, and then 8 weeks of a combination minocycline (200 mg daily) and NAC (1200 mg daily) followed by a final 2 week washout

Active Comparator: minocycline (200 mg daily) and NAC (1200 mg daily) followed by placebo

Participants will be randomized to 8 weeks of a combination minocycline (200 mg daily) and NAC (1200 mg daily), minimum 2 week washout period, and then 8 weeks of placebo followed by a final 2 week washout

Interventions

Drug: - minocycline (200 mg daily) and NAC (1200 mg daily) followed by placebo

minocycline (200 mg daily) and NAC (1200 mg daily) followed by placebo

Drug: - Placebo followed by minocycline (200 mg daily) and NAC (1200 mg daily)

Placebo followed by minocycline (200 mg daily) and NAC (1200 mg daily)

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Medical University of South Carolina, Charleston, South Carolina

Status

Address

Medical University of South Carolina

Charleston, South Carolina, 29425