Myalgic Encephalomyelitis/Chronic Fatigue SyndromePhase 2NCT07285473
Low-Dose Naltrexone For ME/CFS: Dose-Finding
A Phase 2 study testing Low-Dose Naltrexone, 1.5mg, Low-Dose Naltrexone, 3.0mg and Low-Dose Naltrexone, 4.5mg in people with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
This exploratory clinical trial tests low-dose naltrexone (LDN) for the treatment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). A remote trial approach is used, with eligibility open to the state of Alabama. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
- What is being tested?
- Low-Dose Naltrexone, 1.5mg, Low-Dose Naltrexone, 3.0mg and Low-Dose Naltrexone, 4.5mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2026to 1 Apr 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Between ages of 18 and 65
- Living in Alabama
- Meets ME-ICC criteria
Who cannot join
- Abnormal hepatic function
- Abnormal renal function
- Abnormal complete blood count
- Evidence of active or chronic systemic infection
- A1C > 9.0%
- Current opioid analgesic use
Show all 9Show fewer
- Pregnant or plans to become pregnant during the study participation period
- Auto-immune disorder
- Enrolled in other experimental treatment study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35243
Catherine Griffin, 205-975-5907, psych-youngerlab@mail.ad.uab.edu
Rachel Rich, 205-975-5950
About this study
Official title: Low-dose Naltrexone (LDN) for the Treatment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS): Dose-Finding
This exploratory clinical trial tests low-dose naltrexone (LDN) for the treatment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). A remote trial approach is used, with eligibility open to the state of Alabama.
Read the detailed description
This study uses a remote design where individuals can participate from anywhere in the state of Alabama. Study medications will be received by mail. All participants must meet ME-ICC criteria. This study will be tested on participants recruited from Alabama, with a total of 75 participants enrolled for the entire study. Participation will last 10 months.
The first stage of the study is the baseline phase. During this time, participants will complete weekly outcome measurements but will not take any medications. The baseline stage will last for 30 days. This period is used to calculate a stable baseline for determining treatment effects. After the 30-day baseline, the treatment stage will begin.
After the baseline period, participants will receive LDN capsules at one of four doses: 1.5mg/day, 3.0mg/day, 4.5mg/day, and/or 6.0mg/day in a blinded fashion. Capsules are sent by FedEx every two months and are taken daily without breaks. Participants and research assistants dealing with participants are blinded to the dose schedule. Data on adherence to the treatment protocol is monitored using smart pill dispensers. This treatment stage is the longest, lasting 8 months, with participants continuing to complete weekly outcome measures.
After eight months of study capsules, participants will enter a one-month endline phase where no medications are taken. Outcomes will still be completed once per week.
- Being tested
- Low-Dose Naltrexone, 1.5mg, Low-Dose Naltrexone, 3.0mg, Low-Dose Naltrexone, 4.5mg, Low-Dose Naltrexone, 6.0mg
- Keywords
- Myalgic Encephalomyelitis/Chronic Fatigue Syndrome, ME/CFS
- 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.
Low-Dose Naltrexone, 1.5mgDrug
Also called Naltrexone
Low-Dose Naltrexone (LDN) is not a commercially available drug and will be compounded for this study. LDN will be taken orally, up to once per day.
Low-Dose Naltrexone, 3.0mgDrug
Also called Naltrexone
Low-Dose Naltrexone (LDN) is not a commercially available drug and will be compounded for this study. LDN will be taken orally, up to once per day.
Low-Dose Naltrexone, 4.5mgDrug
Also called Naltrexone
Low-Dose Naltrexone (LDN) is not a commercially available drug and will be compounded for this study. LDN will be taken orally, up to once per day.
Low-Dose Naltrexone, 6.0mgDrug
Also called Naltrexone
Low-Dose Naltrexone (LDN) is not a commercially available drug and will be compounded for this study. LDN will be taken orally, up to once per day.
| Study group | Role | What they receive |
|---|---|---|
| Participants Receiving Low-Dose Naltrexone | Experimental | Participants Receiving Low-Dose Naltrexone Receives: Drug: Low-Dose Naltrexone, 1.5mg; Drug: Low-Dose Naltrexone, 3.0mg; Drug: Low-Dose Naltrexone, 4.5mg; Drug: Low-Dose Naltrexone, 6.0mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
PROMIS Fatigue Short Form 7a
This will be measured using weekly surveys.
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study start1 Nov 2026 (estimated)
- Primary completion1 Apr 2028 (estimated)
- Study completion1 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myalgic Encephalomyelitis/Chronic Fatigue SyndromeStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- 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
- NCT07285473
- Sponsor's protocol ID
- IRB-300015917
- Other IDs
- 1UG3NS141843-01A1
- Status last verified
- Oct 2026
- First submitted
- 9 Dec 2025
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-dose Naltrexone (LDN) for the Treatment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS): Dose-Finding
- ClinicalTrials.gov ID
- NCT07285473
- Acronym / sponsor ID
- IRB-300015917
- Keywords
- Myalgic Encephalomyelitis/Chronic Fatigue Syndrome, ME/CFS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Apr 2028 (estimated)
- Study completion
- 1 Apr 2028 (estimated)
- First posted
- 16 Dec 2025 (actual)
- 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.
This exploratory clinical trial tests low-dose naltrexone (LDN) for the treatment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). A remote trial approach is used, with eligibility open to the state of Alabama.
Detailed description
This study uses a remote design where individuals can participate from anywhere in the state of Alabama. Study medications will be received by mail. All participants must meet ME-ICC criteria. This study will be tested on participants recruited from Alabama, with a total of 75 participants enrolled for the entire study. Participation will last 10 months.
The first stage of the study is the baseline phase. During this time, participants will complete weekly outcome measurements but will not take any medications. The baseline stage will last for 30 days. This period is used to calculate a stable baseline for determining treatment effects. After the 30-day baseline, the treatment stage will begin.
After the baseline period, participants will receive LDN capsules at one of four doses: 1.5mg/day, 3.0mg/day, 4.5mg/day, and/or 6.0mg/day in a blinded fashion. Capsules are sent by FedEx every two months and are taken daily without breaks. Participants and research assistants dealing with participants are blinded to the dose schedule. Data on adherence to the treatment protocol is monitored using smart pill dispensers. This treatment stage is the longest, lasting 8 months, with participants continuing to complete weekly outcome measures.
After eight months of study capsules, participants will enter a one-month endline phase where no medications are taken. Outcomes will still be completed once per week.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants Receiving Low-Dose Naltrexone | Experimental | Drug: Low-Dose Naltrexone, 1.5mg, Drug: Low-Dose Naltrexone, 3.0mg, Drug: Low-Dose Naltrexone, 4.5mg, Drug: Low-Dose Naltrexone, 6.0mgParticipants Receiving Low-Dose Naltrexone |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Between ages of 18 and 65
- Living in Alabama
- Meets ME-ICC criteria
Key exclusion criteria (9 listed)
- Abnormal hepatic function
- Abnormal renal function
- Abnormal complete blood count
- Evidence of active or chronic systemic infection
- A1C > 9.0%
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 |
|---|---|---|
| Low-Dose Naltrexone, 1.5mgAlso: NaltrexoneLow-Dose Naltrexone (LDN) is not a commercially available drug and will be compounded for this study. LDN will be taken orally, up to once per day. | Drug | Participants Receiving Low-Dose Naltrexone |
| Low-Dose Naltrexone, 3.0mgAlso: NaltrexoneLow-Dose Naltrexone (LDN) is not a commercially available drug and will be compounded for this study. LDN will be taken orally, up to once per day. | Drug | Participants Receiving Low-Dose Naltrexone |
| Low-Dose Naltrexone, 4.5mgAlso: NaltrexoneLow-Dose Naltrexone (LDN) is not a commercially available drug and will be compounded for this study. LDN will be taken orally, up to once per day. | Drug | Participants Receiving Low-Dose Naltrexone |
| Low-Dose Naltrexone, 6.0mgAlso: NaltrexoneLow-Dose Naltrexone (LDN) is not a commercially available drug and will be compounded for this study. LDN will be taken orally, up to once per day. | Drug | Participants Receiving Low-Dose Naltrexone |
Primary outcome
PROMIS Fatigue Short Form 7a
Time frame: 10 months
This will be measured using weekly surveys.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
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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.
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 Phase 2 study testing Low-Dose Naltrexone, 1.5mg, Low-Dose Naltrexone, 3.0mg and Low-Dose Naltrexone, 4.5mg in people with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome, 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 3 inclusion and 9 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: opening soon, as of the sponsor's last update on 8 Oct 2026. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jarred Younger, PhD (205-975-5821, youngerlab@uab.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PROMIS Fatigue Short Form 7a (time frame: 10 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Oct 2026.