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Potential Clinical Exploring the Uses of Low-Dose

Uses and Trials
for LDN: Naltrexone (LDN)
ALS Naltrexone, an opiate receptor antagonist, years, there has been a growing body
(Lou Gehrig’s Disease) is not a new drug, but when used off label of evidence that the body’s endorphins
at very low doses, is a drug shown in (naturally occurring opioids) have a
Addiction many trials to be of therapeutic benefit. critical role in regulating the immune
The 50mg dose of Naltrexone was system and providing pain relief.
Addison’s Disease
approved by the FDA for opioid and LDN’s blockade of opioid receptors has
Alopecia Areata alcohol addiction in 1984. been shown to upregulate endorphin
production. LDN’s blockade of Toll
Alzheimer’s Disease In 1985, Bernard Bihari, MD, a physician Like Receptors is believed to contribute
with a clinical practice in New York to the anti-inflammatory and immune
Amyotrophic Lateral City, discovered the effects of a much dampening effects. These mechanisms
Sclerosis smaller dose of Naltrexone. When help us understand why LDN can
Ankylosing reduced to doses ranging from 0.5mg to be beneficial for so many patients.
Spondylitis 9.0mg daily, it can modulate the immune LDN continues to provide life changing
outcomes for many patients. It is
Anxiety ...it is critical to work with a provider available only by prescription and custom
or a compounding pharmacy made at a compounding pharmacy.
Atopic Allergy knowledgeable in strategies that
can help ensure success with LDN. The key to success in using LDN is an
Atopic Dermatitis
understanding that optimal dosing is
system and may provide relief to those ultimately patient specific and is not
Þ
suffering from autoimmune diseases, dependent on a set protocol. Dosing
chronic pain, mental health challenges strategies can vary tremendously. Some
Because LDN is an and inflammation. Over the past ten patients find success very quickly, while
others need to try a variety of dosing
opioid receptor blocker, strategies, which may take up to several
caution should be taken months to achieve success. Therefore,
it is critical to work with a provider or a
when prescribing LDN compounding pharmacy knowledgeable
to patients who are in strategies that can help ensure
success with LDN.
taking opioid-type pain
medications such as Since we began specializing in LDN
at the Medicine Center Pharmacy, we
Morphine, Oxycodone, have seen a wide variety of successes.
Hydrocodone It is these successes that motivate us to
Brad White, R.Ph., Pharmacist/
continue to try to help other patients.
and Fentanyl. Vice President/Co-Owner
Potential Clinical
Uses and Trials
for LDN:
Autism Spectrum
Disorders

Behcet’s Disease

Benign Prostatic
Hypertrophy (BPH)

Brain Fog Low-Dose Naltrexone (LDN)

COPD ...for Multiple Sclerosis
CREST Syndrome Cree et al: Naltrexone and QOL in MS Annals of Neurology.
Celiac Disease February 2010(1)1-18 | UC-San Francisco Medical School
Chronic Fatigue Objective: To evaluate the efficacy of treatment with 4.5mg nightly naltrexone
Syndrome 4.5mg nightly naltrexone on the quality (low-dose naltrexone).
of life of patients with multiple sclerosis.
Complex Regional Results: LDN was associated with
Pain Syndrome Population: 80 patients with multiple significant improvement on the 3.3-point
sclerosis between the ages of 18 and 75 Mental Component Summary score
Crohn’s Disease with clinically definite multiple sclerosis General Health Survey (p<0.01).
(International Panel criteria).
Depression Conclusion: Multiple Sclerosis patients
Intervention: This study was conducted receiving 4.5mg of naltrexone (LDN)
Dermatomyositis as a double-masked, placebo-controlled, at night showed significantly improved
crossover study self-reported quality of mental health quality of life indices when
Diabetes Mellitus
Type I life, to evaluate the efficacy of 8 weeks of compared to placebo.

Eczema

Ehlers-Danlos
...for Depression
Syndrome Mischoulon et al: For Patients with Breakthrough Depression of
Endometriosis Major Depressive Disorder (MDD) on Antidepressants. Journal of
Affective Disorders 208 (2017) 6-14 | Harvard Medical School
Fibromyalgia
Objective: To examine the efficacy Results: A variety of depression rating
General anxiety of LDN as an additional therapy for scales were used to evaluate LDN’s
Disorder depression in patients currently taking effectiveness. The MADRS-10 and the
anti-depressant medication. MADRS-15 demonstrated a significant
Granulomatosis
advantage of LDN over placebo.
Population: 12 adult patients ranging
Graves Disease in age from 25-64 with recurrent major-
Conclusion: LDN may have beneficial
depressive disorder currently on
HIV/AIDS effects and good tolerability as an
antidepressant medication.
additional agent for patients with
Hailey-Hailey Disease Intervention: Patients were randomized MDD who continue to experience
to double blind treatment with placebo depression challenges on their current
Hashimoto’s Disease medication therapy.
or Naltrexone 1.0mg twice daily,
2 in addition to their current therapy.

...for Fibromyalgia
Younger et al: Fibromyalgia Symptoms are Reduced by Low-Dose
Naltrexone: A Pilot Study. Pain Medicine 2009(10):663-72 |
Stanford Medical School
Objective: Pilot clinical trial, to test
the effectiveness of LDN in treating
the symptoms of fibromyalgia.
Population: Ten women meeting crite-
ria for moderate to severe fibromyalgia
and not taking an opioid medication.
Intervention: This study was conducted
as a placebo-controlled, single-blind,
crossover to evaluate the efficacy of
8 weeks of treatment with 4.5mg of
naltrexone (LDN) on daily, self-reported
fibromyalgia symptom severity. Each
patient acted as their own control and
...for Crohn’s Disease
Smith et al: Low-Dose Naltrexone Therapy Improves Active
Crohn’s Disease Pilot Study. Am J Gastroenterol 2007;
102:820-828 | Penn State Medical School
Objective: Prospective pilot study for
the safety and efficacy of using LDN in
patients with active Crohn’s disease.
Population: 17 patients with
histologically and endoscopically
confirmed active Crohn’s Disease.
Intervention: Patients with Crohn’s
disease activity index (CDAI) score of
220-450 were enrolled and treated
with 4.5mg naltrexone daily. Infliximab
was not allowed for a minimum of 8 wk
prior to study initiation. Other therapy
for Crohn’s disease that was at a stable
dose for 4 wk prior to enrollment was
continued at the same doses.
Results: 17 patients with a mean CDAI
score of 356 +/- 27 were enrolled. CDAI
Potential Clinical
Uses and Trials
for LDN:
Hypothyroidism
Irritable Bowel
received a placebo for two weeks Syndrome (IBS)
before treatment.
Kawasaki’s Disease
Results: During placebo, symptoms
Lupus
were reduced by 2.3% in the entire
cohort from baseline. In the drug Lyme Disease
condition, symptoms were reduced
by 32.5%. Six out of ten patients Menier’s Disease
treated with LDN were considered
responders (30% or greater reduction Migraine Headaches
of symptoms over placebo). Multiple Sclerosis (MS)
Conclusion: LDN shows promise as Obsessive Compulsive
being a well-tolerated and effective Disorder (OCD)
treatment for fibromyalgia in women.
Pandas Disease
Parkinson’s Disease
Pediatrics
Pemphigoid
Periodontal Disease
Polycystic Ovary
scores decreased significantly (P=0.01)
Syndrome (PCOS)
with LDN, and remained lower than
baseline 4 wk after completing therapy. Þ
Eighty-nine percent of patients
exhibited a response to therapy
and 67% achieved a remission
(P<0.001). Improvement was
recorded in both quality of life
surveys with LDN compared
with baseline. No laboratory
abnormalities were noted.
The most common side
effect was sleep disturbances,
occurring in 7 patients.
Conclusion: LDN appears
to be a safe and effective
treatment for patients
suffering from active
Crohn’s disease.
Potential Clinical
Uses and Trials
for LDN: ...for Inflammation and Pain
Post-Traumatic Stress Younger et al: The Use of Low-Dose Naltrexone (LDN) as a Novel
Disorder (PTSD) Anti-Inflammatory Treatment for Chronic Pain. Clinical Rheumatology
Primary Lateral (2014) 33:451-459 | Stanford Medical School
Sclerosis (PLS)
Objective: Review the evidence of Microglial cells and production of
Psoriasis that LDN may act as a novel anti- inflammatory factors.
inflammatory agent in the Central
Psoriatic Arthritis Nervous System thru its action on In an initial pilot study on fibromyalgia,
microglial cells. baseline erythrocyte sedimentation
Restless Leg rate (ESR) was a significant predictor
Syndrome Content: Additional information about of clinical response from LDN. (ESR
the background, theory, mechanism of is a common test that is sensitive to
Rheumatoid Arthritis action, evidence of effectiveness, published both chronic and acute inflammatory
research on pain disorders, advantages processes).
SIBO
of LDN and disadvantages of LDN.
A variety of chronic inflammatory
Sarcoidosis Evidence of Effectiveness: conditions have been shown to respond
Scleroderma Two proposed mechanisms of action: positively to LDN treatment.
1. Brief blockade of opiate receptors Conclusion: The totality of the basic and
Sjogren’s Syndrome resulting in increased endorphin clinical research to date suggests that
production and pain relief LDN is a promising treatment approach
Stiff Person Syndrome
(SPS) 2. Brief blockade of non-opiate receptors for chronic pain conditions thought to
(TLR receptors) preventing activation involve inflammatory processes.
Transverse Myelitis

Ulcerative Colitis MEDICINE CENTER PHARMACY

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New Philadelphia, OH 44663
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