Effects of Low Dose Naltrexone in Fibromyalgia

This study has been completed.
Sponsor:
Collaborator:
American Fibromyalgia Syndrome Association
Information provided by (Responsible Party):
Sean Mackey, Stanford University
ClinicalTrials.gov Identifier:
NCT00568555
First received: December 4, 2007
Last updated: September 21, 2015
Last verified: September 2015
  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.

Condition Intervention
Fibromyalgia
Persian Gulf Syndrome
Drug: Low Dose Naltrexone
Drug: Placebo - sugar pill

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Low Dose Naltrexone in Fibromyalgia

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Percent Change in Pain Scores Between Baseline to End of Placebo Treatment and Between Baseline to End of LDN Treatment. [ Time Frame: Baseline to end of placebo (2 weeks + 4 weeks) and baseline to end of LDN (2 weeks + 12 weeks) ] [ Designated as safety issue: No ]

    Visual Analogue Scale for pain, 0 to 100, where 0=no pain and 100=worst pain imaginable.

    Baseline pain calculated averaging daily pain scores over the 2 week baseline period.

    Placebo and LDN pain scores calculated by averaging daily pain scores during the final 3 days of each condition.

    Values were converted to percent change in pain: [(baseline pain - end point pain)/baseline pain] x 100.



Secondary Outcome Measures:
  • Percent Change in Sleep Quality Scores Between Baseline to End of Placebo Treatment and Between Baseline to End of LDN Treatment. [ Time Frame: Baseline to end of placebo (2 weeks + 4 weeks) and baseline to end of LDN (2 weeks + 12 weeks) ] [ Designated as safety issue: No ]

    Visual Analogue Scale for sleep quality, 0 to 100, where 0 = "did not sleep well at all" and 100 = "slept extremely well".

    Baseline sleep quality calculated by averaging daily scores over the 2 week baseline period.

    Placebo and LDN sleep quality scores calculated by averaging daily scores during the final 3 days of each condition.

    Values were converted to percent change in sleep quality: [(baseline sleep - end point sleep)/baseline sleep] x 100.


  • Percent Change in Fatigue Scores Between Baseline to End of Placebo Treatment and Between Baseline to End of LDN Treatment. [ Time Frame: Baseline to end of placebo (2 weeks + 4 weeks) and baseline to end of LDN (2 weeks + 12 weeks) ] [ Designated as safety issue: No ]

    Visual Analogue Scale for fatigue, 0 to 100, where 0 = "no fatigue at all" and 100 = "severe fatigue".

    Baseline fatigue calculated averaging daily scores over the 2 week baseline period.

    Placebo and LDN fatigue scores calculated by averaging daily scores during the final 3 days of each condition.

    Values were converted to percent change in fatigue: [(baseline fatigue - end point fatigue)/baseline fatigue] x 100.


  • Percent Change in Pressure Pain Threshold Between Baseline and End of Placebo Treatment and Between Baseline to End of LDN Treatment. [ Time Frame: Baseline to end of placebo (2 weeks + 4 weeks) and baseline to end of LDN (2 weeks + 12 weeks) ] [ Designated as safety issue: No ]
    An algometer is used to apply pressure to 18 points across the body. Pressure is applied until the first sensation of pain in indicated. This pressure is recorded (as kg/cm2) and averaged for all 18 points to provide an overall score.

  • Percent Change in Heat Pain Sensitivity Between Baseline and End of Placebo Treatment and Between Baseline to End of LDN Treatment. [ Time Frame: Baseline to end of placebo (2 weeks + 4 weeks) and baseline to end of LDN (2 weeks + 12 weeks) ] [ Designated as safety issue: No ]
    A thermode is placed on the palm, and temperature is increased until the first sensation of pain. That temperature is recorded in Degrees Celsius . The procedure is repeated 3 times and results are averaged into a single temperature recording.


Enrollment: 53
Study Start Date: June 2007
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Low Dose Naltrexone first
LDN first, then placebo.
Drug: Low Dose Naltrexone
3-4.5mg Naltrexone once daily
Drug: Placebo - sugar pill
Placebo pill once daily
Placebo Comparator: Placebo - sugar pill first
Placebo first, then LDN.
Drug: Low Dose Naltrexone
3-4.5mg Naltrexone once daily
Drug: Placebo - sugar pill
Placebo pill once daily

Detailed Description:
This study will be a placebo-controlled, double-blind, cross-over drug tria. 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   (Adult)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
American Fibromyalgia Syndrome Association
Investigators
Sub-Investigator: Jarred Younger Stanford University
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sean Mackey, Associate Professor, Stanford University
ClinicalTrials.gov Identifier: NCT00568555     History of Changes
Other Study ID Numbers: SU-10232007-756  8948 
Study First Received: December 4, 2007
Results First Received: April 10, 2013
Last Updated: September 21, 2015
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Persian Gulf Syndrome
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Occupational Diseases
Naltrexone
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on July 28, 2016