Low-Dose Naltrexone For ME/CFS: Dose-Finding | NCT07285473

Studies
Low-Dose Naltrexone For ME/CFS: Dose-Finding

NCT07285473

Sponsor

University of Alabama at Birmingham

Status

Not yet recruiting

Last Update Posted

May 14, 2026Actual

Enrollment

75Estimated

Phase

Phase 2

Conditions

Myalgic Encephalomyelitis/Chronic Fatigue Syndrome

Interventions

Low-Dose Naltrexone, 1.5mg
Low-Dose Naltrexone, 3.0mg
Low-Dose Naltrexone, 4.5mg
Low-Dose Naltrexone, 6.0mg

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
1UG3NS141843-01A1	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

May 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2026Estimated

Primary Completion Date

Apr 1, 2028Estimated

Completion Date

Apr 1, 2028Estimated

First Submitted Date

Dec 9, 2025

First Submission Date that Met QC Criteria

Dec 9, 2025

First Posted Date

Dec 16, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 11, 2026

Last Update Posted Date

May 14, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jarred Younger, Professor, University of Alabama at BirminghamPrincipal Investigator

Lead Sponsor

University of Alabama at BirminghamOTHER

Collaborators

Name	Class
National Institute of Neurological Disorders and Stroke (NINDS)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

75Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Participants Receiving Low-Dose Naltrexone	Experimental	Participants Receiving Low-Dose Naltrexone	Drug: Low-Dose Naltrexone, 1.5mg Drug: Low-Dose Naltrexone, 3.0mg Drug: Low-Dose Naltrexone, 4.5mg Drug: Low-Dose Naltrexone, 6.0mg

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Low-Dose Naltrexone, 1.5mg	Drug	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
PROMIS Fatigue Short Form 7a	This will be measured using weekly surveys.	10 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Between ages of 18 and 65
Living in Alabama
Meets ME-ICC criteria

Exclusion Criteria:

Abnormal hepatic function
Abnormal renal function
Abnormal complete blood count
Evidence of active or chronic systemic infection
A1C > 9.0%
Current opioid analgesic use
Pregnant or plans to become pregnant during the study participation period
Auto-immune disorder
Enrolled in other experimental treatment study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jarred Younger, PhD	Contact	205-975-5821		youngerlab@uab.edu

Overall Officials

Name	Affiliation	Role
Jarred Younger, PhD	University of Alabama at Birmingham	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Alabama at Birmingham		Birmingham	Alabama	35243	United States

Condition Browse Module

MeSH Terms

ID	Term
D015673	Fatigue Syndrome, Chronic

Ancestor Terms

ID	Term
D009135	Muscular Diseases
D009140	Musculoskeletal Diseases
D004679	Encephalomyelitis
D000090862	Neuroinflammatory Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D009271	Naltrexone

Ancestor Terms

ID	Term
D009270	Naloxone
D009019	Morphinans
D053610	Opiate Alkaloids
D000470	Alkaloids
D006571

Browse Leaves

Not provided

Browse Branches

Not provided

Masking Info

Masking

None (Open Label)

Masking Description

This study is single-blind, participants will not know when they received 1.5mg/day, 3.0mg/day, 4.5mg/day, or 6.0mg/day low-dose naltrexone.

Who Masked

Not provided