Immune Effects of Low-dose Naltrexone in ME/CFS
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ClinicalTrials.gov Identifier: NCT02965768 |
Recruitment Status :
Suspended
(Temporarily suspended to focus on other projects. At suspension, no participants were determined eligible and none started the protocol.)
First Posted : November 17, 2016
Last Update Posted : September 5, 2021
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Condition or disease | Intervention/treatment | Phase |
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Fatigue Syndrome, Chronic | Drug: Naltrexone HCl | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 30 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Masking Description: | Double-blind trial. An encrypted and password-protected database will contain (1) information about individual group assignment, and (2) blister pack codes (medication will be dispensed in blister packs by investigators based on these codes). An investigator not involved with data collection or participant interactions will randomly assign individuals to the treatment group and provide blister pack ID codes for each individual. |
Primary Purpose: | Other |
Official Title: | The Immune Effects of Low-dose Naltrexone in People With Myalgic Encephalopathy/Chronic Fatigue Syndrome (ME/CFS) |
Study Start Date : | January 2016 |
Estimated Primary Completion Date : | August 1, 2022 |
Estimated Study Completion Date : | August 1, 2022 |

Arm | Intervention/treatment |
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Active Comparator: LDN arm
Naltrexone HCl 4.5mg (standard-dose) or 3.0mg (optional-dose) x24 weeks
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Drug: Naltrexone HCl
4.5 mg Naltrexone HCl, p.o., nocte (standard-dose); 3.0 mg Naltrexone HCl, p.o., nocte (optional-dose);
Other Names:
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Placebo/LDN arm
Naltrexone HCl 4.5mg (standard-dose) or 3.0mg (optional-dose) Placebo Individuals will be switched between drugs as per approved schedule during the 24 weeks. |
Drug: Naltrexone HCl
4.5 mg Naltrexone HCl, p.o., nocte (standard-dose); 3.0 mg Naltrexone HCl, p.o., nocte (optional-dose);
Other Names:
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- Reduction in plasma inflammatory biomarkers [ Time Frame: Four-week baseline; 12 weeks drug ]Levels of plasma IL-1B, TNFa, IL6, IL12, and IL17 will be tested as the primary biomarkers of interest.
- Durability of reduction in plasma inflammatory biomarkers [ Time Frame: Baseline; 12 weeks drug; 24 weeks drug ]Levels of plasma IL-1B, TNFa, IL6, IL12, and IL17 will be tested as the primary biomarkers of interest. 24 weeks vs 12 weeks drug.
- Reduction in self-reported fatigue [ Time Frame: 12 weeks drug ]Fatigue will be reported daily on a hand-held computer device.
- Increase in physical function [ Time Frame: 12 weeks drug ]Physical function will be reported weekly on a Patient-Specific Functional Scale.
- Reduction in self-reported symptoms of (i) depression, (ii) anxiety [ Time Frame: 12 weeks drug ]Symptoms of depression and anxiety will be reported weekly on a Hospital Anxiety and Depression Scale.

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
1. Meet the 1994 Case Definition criteria for CFS (assessed through semi-structured interview and the DePaul University Fatigue Questionnaire):
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Criteria:
- Severe chronic fatigue ≥6 consecutive months not due to ongoing exertion or other medical condition associated with fatigue;
- Fatigue interferes with daily activities and work;
- Reports ≥4 symptoms that started with or after the fatigue, from:
- Post-exertion malaise >24 hours
- Unrefreshing sleep
- Short-term memory or concentration impairment
- Muscle pain
- Joint pain without swelling or redness
- Headaches of a new type/pattern/severity
- Lymph node tenderness
- Frequent or recurring sore throat 3. CFS symptoms for ≥12 months 4. Participant completes daily self-report during the 4-week baseline period; 5. Able to attend UAB on all scheduled appointments
Exclusion Criteria:
- Blood draw contraindicated or otherwise not able to be performed
- High-sensitivity c-reactive protein (HS-CRP) ≥3 mg/L
- Erythrocyte sedimentation rate (ESR) >60 mm/hr
- Positive rheumatoid factor
- Positive anti-nuclear antibody (ANA)
- Levels of thyroid stimulating hormone or free thyroxine outside UAB lab reference values
- Diagnosed rheumatological or auto-immune condition
- Clotting disorder
- Use of blood thinning medication
- Oral temperature >100˚F at baseline
- Febrile illness or use of antibiotics in the 4 weeks before study commencement;
- Planned surgery or procedures during the study period, or operated on in the 4 weeks before study commencement
- Pregnant or planning on becoming pregnant within 6 months
- Regular use of any anti-inflammatory medication (such as aspirin, ibuprofen, naproxen)
- Known allergy or adverse effects following naltrexone or naloxone administration
- Opioid use (self-reported or positive on urine test)
- Significant psychological comorbidity that in the discretion of the investigator compromises study integrity and/or a baseline HADS depression subscale score of ≥16
- Current litigation or worker's compensation claim
- Current participation in another treatment trial
- Vaccinated in the 4 weeks before study commencement (vaccination during the study period is allowed as long as the drug is administered at least 4 weeks prior to a study blood draw).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02965768
United States, Alabama | |
University of Alabama at Birmingham | |
Birmingham, Alabama, United States, 35294 |
Principal Investigator: | Jarred Younger, PhD | University of Alabama at Birmingham |
Responsible Party: | Jarred Younger, Associate Professor, University of Alabama at Birmingham |
ClinicalTrials.gov Identifier: | NCT02965768 |
Other Study ID Numbers: |
F160525003 |
First Posted: | November 17, 2016 Key Record Dates |
Last Update Posted: | September 5, 2021 |
Last Verified: | September 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Fatigue Syndrome, Chronic Syndrome Fatigue Disease Pathologic Processes Virus Diseases Infections Muscular Diseases Musculoskeletal Diseases Encephalomyelitis |
Central Nervous System Diseases Nervous System Diseases Neuromuscular Diseases Naltrexone Alcohol Deterrents Narcotic Antagonists Physiological Effects of Drugs Sensory System Agents Peripheral Nervous System Agents |