Fatigue Syndrome, ChronicNCT02965768
Immune Effects of Low-dose Naltrexone in ME/CFS
A study testing Naltrexone HCl in people with Fatigue Syndrome, Chronic, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
The main objective of this study is to test if naltrexone, when taken in low doses, has an anti-inflammatory effect that may be associated with positive clinical outcomes in people with chronic fatigue syndrome (CFS). Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Fatigue Syndrome, Chronic
- What is being tested?
- Naltrexone HCl
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to 25 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Meet the 1994 Case Definition criteria for CFS (assessed through semi-structured interview and the DePaul University Fatigue Questionnaire):
- 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
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- 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
Who cannot join
- 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
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- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294
About this study
Official title: The Immune Effects of Low-dose Naltrexone in People With Myalgic Encephalopathy/Chronic Fatigue Syndrome (ME/CFS)
The main objective of this study is to test if naltrexone, when taken in low doses, has an anti-inflammatory effect that may be associated with positive clinical outcomes in people with chronic fatigue syndrome (CFS). In part, the present study, is a continuation of prior work in which we showed that chronic fatigue symptoms are associated with immune activity, and that low-dose naltrexone might exert anti-inflammatory effects in fibromyalgia, which is thought to share some pathophysiological and clinical characteristics with CFS.
- Conditions
- Fatigue Syndrome, Chronic
- Being tested
- Naltrexone HCl
- Medical subject headings
- Fatigue Syndrome, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Naltrexone HClDrug
Also called Low-dose Naltrexone, LDN
4.5 mg Naltrexone HCl, p.o., nocte (standard-dose); 3.0 mg Naltrexone HCl, p.o., nocte (optional-dose);
| Study group | Role | What they receive |
|---|---|---|
| LDN arm | Active comparator | Naltrexone HCl 4.5mg (standard-dose) or 3.0mg (optional-dose) x24 weeks Receives: Drug: Naltrexone HCl |
| Placebo/LDN arm | Other | 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. Receives: Drug: Naltrexone HCl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in plasma inflammatory biomarkers
Levels of plasma IL-1B, TNFa, IL6, IL12, and IL17 will be tested as the primary biomarkers of interest.
Measured: Four-week baseline; 12 weeks drug
Secondary outcomes (4)
Durability of reduction in plasma inflammatory biomarkers
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.
Measured: Baseline; 12 weeks drug; 24 weeks drug
Reduction in self-reported fatigue
Fatigue will be reported daily on a hand-held computer device.
Measured: 12 weeks drug
Increase in physical function
Physical function will be reported weekly on a Patient-Specific Functional Scale.
Measured: 12 weeks drug
Reduction in self-reported symptoms of (i) depression, (ii) anxiety
Symptoms of depression and anxiety will be reported weekly on a Hospital Anxiety and Depression Scale.
Measured: 12 weeks drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2016 (estimated)
- Study startJan 2016
- Primary completion25 Aug 2022
- Study completion25 Aug 2022
Why it stopped: Study was temporarily suspended to focus on other projects, but was never resumed. No participants were determined eligible and none started the protocol.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fatigue Syndrome, ChronicStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jarred Younger, University of Alabama at Birmingham
- Investigators
- Jarred Younger, PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02965768
- Sponsor's protocol ID
- F160525003
- Status last verified
- Aug 2022
- First submitted
- 14 Nov 2016
- Last updated
- 2 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Younger J, Parkitny L, McLain D. The use of low-dose naltrexone (LDN) as a novel anti-inflammatory treatment for chronic pain. Clin Rheumatol. 2014 Apr;33(4):451-9. doi: 10.1007/s10067-014-2517-2. Epub 2014 Feb 15.
PubMed 24526250
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Immune Effects of Low-dose Naltrexone in People With Myalgic Encephalopathy/Chronic Fatigue Syndrome (ME/CFS)
- ClinicalTrials.gov ID
- NCT02965768
- Acronym / sponsor ID
- F160525003
- Conditions
- Fatigue Syndrome, Chronic
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was temporarily suspended to focus on other projects, but was never resumed. No participants were determined eligible and none started the protocol.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- 25 Aug 2022 (actual)
- Study completion
- 25 Aug 2022 (actual)
- First posted
- 17 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objective of this study is to test if naltrexone, when taken in low doses, has an anti-inflammatory effect that may be associated with positive clinical outcomes in people with chronic fatigue syndrome (CFS). In part, the present study, is a continuation of prior work in which we showed that chronic fatigue symptoms are associated with immune activity, and that low-dose naltrexone might exert anti-inflammatory effects in fibromyalgia, which is thought to share some pathophysiological and clinical characteristics with CFS.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LDN arm | Active comparator | Drug: Naltrexone HClNaltrexone HCl 4.5mg (standard-dose) or 3.0mg (optional-dose) x24 weeks |
| Placebo/LDN arm | Other | Drug: Naltrexone HClNaltrexone 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 1. Meet the 1994 Case Definition criteria for CFS (assessed through semi-structured interview and the DePaul University Fatigue Questionnaire):
- Criteria:
- Post-exertion malaise >24 hours
- Unrefreshing sleep
- Short-term memory or concentration impairment
Key exclusion criteria (20 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Naltrexone HClAlso: Low-dose Naltrexone, LDN4.5 mg Naltrexone HCl, p.o., nocte (standard-dose); 3.0 mg Naltrexone HCl, p.o., nocte (optional-dose); | Drug | LDN arm, Placebo/LDN arm |
Primary outcome
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.
4 secondary outcomes
Durability of reduction in plasma inflammatory biomarkers
Time frame: Baseline; 12 weeks drug; 24 weeks drug
Reduction in self-reported fatigue
Time frame: 12 weeks drug
Increase in physical function
Time frame: 12 weeks drug
Reduction in self-reported symptoms of (i) depression, (ii) anxiety
Time frame: 12 weeks drug
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2022.
- Background: PubMed 24526250Younger J, Parkitny L, McLain D. The use of low-dose naltrexone (LDN) as a novel anti-inflammatory treatment for chronic pain. Clin Rheumatol. 2014 Apr;33(4):451-9. doi: 10.1007/s10067-014-2517-2. Epub 2014 Feb 15.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jarred Younger, PhD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Naltrexone HCl in people with Fatigue Syndrome, Chronic, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 2 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in plasma inflammatory biomarkers (time frame: Four-week baseline; 12 weeks drug). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02965768, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2022.