Effects of Low Dose Naltrexone in Fibromyalgia

• ClinicalTrials.gov Identifier: NCT00568555
• Recruitment Status: Completed
• First Posted: December 6, 2007
• Results First Posted: October 21, 2015
• Last Update Posted: October 21, 2015
• Sponsor: Stanford University
• Collaborator: American Fibromyalgia Syndrome Association
• Information provided by (Responsible Party): Sean Mackey, Stanford University

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Fibromyalgia; Persian Gulf Syndrome	Drug: Low Dose Naltrexone; Drug: Placebo - sugar pill	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 53 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Effects of Low Dose Naltrexone in Fibromyalgia
• Study Start Date: June 2007
• Actual Primary Completion Date: January 2010
• Actual Study Completion Date: January 2010

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. 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) ]

   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 :

1. 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) ]

   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.

2. 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) ]

   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.

3. 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) ]
   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.
4. 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) ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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):

Younger J, Noor N, McCue R, Mackey S. Low-dose naltrexone for the treatment of fibromyalgia: findings of a small, randomized, double-blind, placebo-controlled, counterbalanced, crossover trial assessing daily pain levels. Arthritis Rheum. 2013 Feb;65(2):529-38. doi: 10.1002/art.37734.

• Responsible Party: Sean Mackey, Associate Professor, Stanford University
• ClinicalTrials.gov Identifier: NCT00568555
• Other Study ID Numbers: SU-10232007-756; 8948
• First Posted: December 6, 2007
• Results First Posted: October 21, 2015
• Last Update Posted: October 21, 2015
• Last Verified: September 2015

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; Alcohol Deterrents; Narcotic Antagonists; Physiological Effects of Drugs; Sensory System Agents; Peripheral Nervous System Agents