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Opioid Antagonist

LDN for Complex Regional Pain Syndrome (LDN-CRPS Trial)

N/A

Recruiting

Led By Sean Mackey, MD, PhD

Research Sponsored by Stanford University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Upper and/or lower extremity CRPS

CRPS for at least 1 year

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 4 weeks after conclusion of treatment.

Awards & highlights

LDN-CRPS Trial Summary

This trial is testing whether low-dose naltrexone can help relieve symptoms of complex regional pain syndrome. Participants will be given either LDN or a placebo for a few weeks, and will be asked to come in for several visits, which will include tests, physical assessments, and questionnaires.

Who is the study for?

This trial is for individuals with Complex Regional Pain Syndrome (CRPS) in an arm or leg, who have been on a stable treatment plan for at least 3 months and have had CRPS for over a year. They must meet specific criteria called the Budapest criteria to participate. People allergic to naltrexone or naloxone, using opioid painkillers or illegal opioids, or who are pregnant or planning pregnancy cannot join.Check my eligibility

What is being tested?

The study is examining if low-dose naltrexone (LDN) can help relieve symptoms of CRPS compared to a placebo. Participants will be randomly chosen to receive either LDN or a placebo and will attend study visits and fill out questionnaires over several weeks.See study design

What are the potential side effects?

While not specified here, common side effects of low-dose naltrexone may include headaches, trouble sleeping, nausea, fatigue, and dizziness. Placebo typically has no active ingredients but can lead to perceived side effects.

LDN-CRPS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have CRPS in my arms and/or legs.

Select...

I have had CRPS for at least one year.

LDN-CRPS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 4 weeks after conclusion of treatment.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 4 weeks after conclusion of treatment.

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 4 weeks after conclusion of treatment. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Changes in pain severity

Side effects data

From 2015 Phase 2 trial • 110 Patients • NCT01303835

67%

Fatigue

59%

Hyperglycemia

54%

Platelet count decreased

37%

Constipation

33%

White blood cell decreased

33%

Anemia

31%

Lymphocyte count decreased

30%

Hypocalcemia

30%

Alanine aminotransferase increased

30%

Aspartate aminotransferase increased

28%

Nausea

28%

Hypokalemia

19%

Hyponatremia

17%

Neutrophil count decreased

17%

Hypoalbuminemia

15%

Anorexia

15%

Headache

13%

Insomnia

11%

Vomiting

11%

Seizure

11%

Blood bilirubin increased

11%

Postnasal drip

Thromboembolic event

Edema limbs

Weight loss

Dyspnea

Creatinine increased

Hypernatremia

Hoarseness

Psychiatric disorders - Other, specify

Pruritus

Tremor

Anxiety

Upper respiratory infection

Rash maculo-papular

Hypertension

Mucositis oral

Proteinuria

Dehydration

Hyperkalemia

Hypoglycemia

Dysgeusia

Memory impairment

Fever

Alkaline phosphatase increased

Acute kidney injury

Dry skin

Confusion

Blurred vision

Gastroesophageal reflux disease

Urinary tract infection

Muscle weakness left-sided

Muscle weakness right-sided

Paresthesia

Depression

Diarrhea

Fall

Arthralgia

Generalized muscle weakness

Epistaxis

Muscle weakness lower limb

Hypersomnia

Back pain

Allergic rhinitis

Renal calculi

Urinary incontinence

Infections and infestations - Other, specify: LYME'S DX

Skin and subcutaneous tissue disorders-MACULAR ERRYTHEMATOUS, BACK AND ABDOMEN

Chest pain - cardiac

Papulopustular rash

Weight gain

Cough

Edema face

Abdominal pain

Gastrointestinal disorders - Other, specify: CHIPPED TOOTH

Gastrointestinal disorders - Other, specify: GI BUG

Hemorrhoids

Chills

Non-cardiac chest pain

Cholecystitis

Infections and infestations - Other, specify: H-PYLORI

Infections and infestations - Other, specify: LLE CELLULITIS

Infections and infestations - Other, specify: SHINGLES

Radiation recall reaction (dermatologic)

Chest wall pain

Musculoskeletal and connective tissue disorder - Other, specify: CRAMPS IN FEET

Myalgia

Myositis

Neck pain

Pain in extremity

Cerebrospinal fluid leakage

Cognitive disturbance

Dysphasia

Nervous system disorders - Other, specify: BASELINE L HEMIPARESIS

Nervous system disorders - Other, specify: DECREASED GRIP STRENGTH IN R HAND

Nervous system disorders - Other, specify: L HEMIPARESIS

Nervous system disorders - Other, specify: LE WEAKNESS

Peripheral sensory neuropathy

Agitation

Pulmonary edema

Dyspepsia

Ataxia

Conduction disorder

Flu like symptoms

Edema cerebral

Nasal congestion

Pneumonitis

Sore throat

Alopecia

Rash acneiform

100%

80%

60%

40%

20%

Study treatment Arm

Naltrexone

Placebo

LDN-CRPS Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: LDNExperimental Treatment1 Intervention

Naltrexone HCL, 4.5 mg, Once a day.

Group II: PlaceboPlacebo Group1 Intervention

Sugar pill

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

LDN

2011

Completed Phase 2

~110

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor

2,395 Previous Clinical Trials

17,341,500 Total Patients Enrolled

Sean Mackey, MD, PhDPrincipal Investigator - Stanford University

Lucile Packard Children's Hospital Stanford, Stanford Hospital

University Of Arizona College Of Medicine (Medical School)

Tucson Hsps Medical Ed Prog Inc (Residency)

2 Previous Clinical Trials

563 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do I meet the criteria to participate in this research endeavor?

"A maximum of 40 individuals between 18 and 65 years old who have been diagnosed with CRPS will be accepted into this trial. In addition, applicants must have upper or lower extremity CRPS, remain on a stable treatment regimen for at least 3 months prior to the study, have had their diagnosis for one year, and satisfy the Budapest criteria associated with complex regional pain syndromes."

Answered by AI

Are applicants over 70 years old prohibited from participating in this trial?

"This trial requires individuals between 18 and 65 years old. Those younger than 18 can access 378 different clinical trials, while those older than 65 have access to 998 studies."

Answered by AI

How many participants are being enlisted for this clinical trial?

"Affirmative. According to clinicaltrials.gov, the search for suitable patients is ongoing and has been since June 1st 2015. The most recent update was on August 15th 2022 and 40 individuals are required from a single site."

Answered by AI

Are there still vacancies available for participants in this clinical trial?

"Indeed, clinicaltrials.gov reflects that this research is presently seeking participants. This experiment was initially advertised on June 1st 2015 and had its most recent update 15th August 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Low-Dose Naltrexone for the Treatment of Complex Regional Pain Syndrome

Sean Mackey 2015. "Low-Dose Naltrexone for the Treatment of Complex Regional Pain Syndrome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02502162.

All > Complex Regional Pain Syndrome