LDNaltrexone Clinical Trial At Stanford for CFS/FM

Discussion in 'Fibromyalgia and ME & Chronic Fatigue Syndrome' started by ulala, Jul 13, 2008.

  1. ulala

    ulala New Member

    Effects of Low Dose Naltrexone in Fibromyalgia

    This study is currently recruiting participants.
    I've read so much positive resutls for LDS. I'm going to ask my doctor for it. Any one else?

    Verified by Stanford University, April 2008

    Sponsored by: Stanford University

    Information provided by: Stanford University
    ClinicalTrials.gov Identifier: NCT00568555

    Purpose
    Low Dose Naltrexone (LDN) has been reported anecdotally to reduce the symptoms of Fibromyalgia, a Chronic Multisystem Illness. The drug may work by regulating natural pain-reducing systems. In this study, we will administer both LDN and placebo to a small group of individuals with Fibromyalgia and Gulf War Syndrome, both Chronic Multisymptom Illnesses, to assess the drug's efficacy in treating the condition.



    Study Type: Interventional
    Study Design: Treatment, Non-Randomized, Single Blind, Placebo Control, Single Group Assignment, Efficacy Study

    Official Title: Effects of Low Dose Naltrexone in Fibromyalgia


    Pain

    Fatigue

    Sleep quality



    Secondary Outcome Measures:
    Mechanical Pain Sensitivity

    Thermal Pain Sensitivity


    Estimated Enrollment: 60
    Study Start Date: June 2007

    Detailed Description:
    This study will be a placebo-controlled, single-blind, pre-post drug trial. Patients with Primary Fibromyalgia or Gulf War Syndrome will be recruited from the Stanford University Pain Management Center and the surrounding community. Participation in the study will cover 22 weeks. Participants will attend a laboratory session 12 times for progress checkups, and will complete daily measures of symptoms.

    Eligibility
    Ages Eligible for Study: 18 Years to 65 Years
    Genders Eligible for Study: Both
    Accepts Healthy Volunteers: No

    Criteria

    Inclusion Criteria:Currently suffering from moderate to severe Fibromyalgia or symptoms of Gulf War Syndrome Age 18-65. Not taking any opioid analgesic Not pregnant or planning to become pregnant. Exclusion Criteria:Any known allergy to naltrexone or naloxone.

    Actual or planned pregnancy.

    Contacts and Locations


    Please refer to this study by its ClinicalTrials.gov identifier: NCT00568555

    Locations


    United States, California
    Stanford University School of Medicine Recruiting
    Stanford, California, United States, 94305
    Contact: Jarred Younger LDN_Younger@stanford.edu
    Principal Investigator: Sean Mackey
    Sub-Investigator: Jarred Younger


    Sponsors and Collaborators


    Stanford University


    Investigators


    Principal Investigator: Sean Mackey Stanford University

    More Information

    Study ID Numbers: SU-10232007-756, 8948
    First Received: December 4, 2007
    Last Updated: April 4, 2008
    ClinicalTrials.gov Identifier: NCT00568555
    Health Authority: USA:Office of Human Research Protection


    Study placed in the following topic categories:
    Muscular Diseases
    Neuromuscular Diseases
    Musculoskeletal Diseases
    Myofascial Pain Syndromes
    Fibromyalgia
    Naltrexone
    Disorders of Environmental Origin
    Occupational Diseases
    Pain
    Rheumatic Diseases
    Persian Gulf Syndrome


    Additional relevant MeSH terms:
    Fibromyalgia
    Myofascial Pain Syndromes
    Disease
    Nervous System Diseases
    Narcotic Antagonists
    Physiological Effects of Drugs
    Pharmacologic Actions
    Pathologic Processes
    Sensory System Agents
    Syndrome
    Therapeutic Uses
    Peripheral Nervous System Agents
    Central Nervous System Agents


    ClinicalTrials.gov processed this record on July 11, 2008

    [This Message was Edited on 07/13/2008]
  2. simonedb

    simonedb Member

    hey i have cfs and also a messed up neck, never sure which is most responsible for the pain I can get especially in the neck area, so i decided to try ldn and off mild opiate I was on---just this last week. went off my med the 3 days the pharmacist said necessary and started the ldn wed.
    It was hard going off my pain med but then the LDN seemed really easy to tolerate which is unusual for me so thats nice. I was actually feeling pretty much the same as on pain med until today, I was really psyched about the LDN. Howevr today my neck hurts like heck and I am nervous about it, as the pain med usually kept that pattern at bay and I dont want that feedback loop to start up again.
    I am definitely going to give it more time because too soon to judge, but my tolerance to pain is low so this better not continue too long. advil definitely doesnt do the trick.

    If anyone reading this can recommend a strong safe pain reliever to take with LDN please let me know--and no to tylenol, ibuprofen, naproxyn and aspirin, ya gotta do better, probly isnt anything and i put on lidocaine ointment.
  3. ulala

    ulala New Member

    Dr. Bernard Bihari, 212-929-4196 has had very good results with patients. I hope you can get it and have great results!

    Simon-if you google "low dose naltrexone" cfs
    there's a lot of info about LDN used for CFS. I'm just learning about it. I hope you can stay with it and get some good pain releif.
  4. MamaDove

    MamaDove New Member


    I have taken my 26th dose of LDN lastnight...

    I am only up to 2.0mg which is not at therapeutic level for what I am taking it for, Crohn's colitis...

    Within the first days of taking LDN I had interesting reduction in fibro pain and fatigue...

    I began a thread on here to share my progress but to be honest, I have so much going on that I forget to find the post and add to it...Guess it does nothing for brain fog...

    Seek out as much info on LDN and decide if it is right for you...I have been begging for this medication for 18 months and finally found a doc to prescribe...Well, I tell my story in my original post...Guess I will go now and Bump it up so others can read...

    I believe this is one drug that has great possibilities along with minimal side effects.

    Peace~MamaDove
  5. rachel76

    rachel76 New Member

    I read your experience Mamma dove, thanks for posting it.

    I started LDN 4.5mg 4 weeks ago. It has done nothing for me - not made anything worse or better.
    I find it very easy to tolerate though. Usually I cannot take anything because I have severe IBS with constipation , GERD etc. but this did no harm. Even though it has not helped me, I still would recommend anyone to try it.

    The only effect it has is that I take it in the morn (I did not want the insomnia side effect - I already have that without LDN.) I found that it helps me keep awake in the day which helps me ready for sleep at night.