Effects of Low Dose Naltrexone in Fibromyalgia

Fibromyalgia Clinical Trial

Official title:

Effects of Low Dose Naltrexone in Fibromyalgia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00568555
• Other study ID #: SU-10232007-756
• Secondary ID: 8948
• Status: Completed
• Phase: N/A
• First received: December 4, 2007
• Last updated: September 21, 2015
• Start date: June 2007
• Est. completion date: January 2010

Study information

• Verified date: September 2015
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes
• Persian Gulf Syndrome

Intervention

Drug:
• Low Dose Naltrexone
3-4.5mg Naltrexone once daily
• Placebo - sugar pill
Placebo pill once daily

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	American Fibromyalgia Syndrome Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Change in Pain Scores Between Baseline to End of Placebo Treatment and Between Baseline to End of LDN Treatment.	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.	Baseline to end of placebo (2 weeks + 4 weeks) and baseline to end of LDN (2 weeks + 12 weeks)	No
Secondary	Percent Change in Sleep Quality Scores Between Baseline to End of Placebo Treatment and Between Baseline to End of LDN Treatment.	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.	Baseline to end of placebo (2 weeks + 4 weeks) and baseline to end of LDN (2 weeks + 12 weeks)	No
Secondary	Percent Change in Fatigue Scores Between Baseline to End of Placebo Treatment and Between Baseline to End of LDN Treatment.	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.	Baseline to end of placebo (2 weeks + 4 weeks) and baseline to end of LDN (2 weeks + 12 weeks)	No
Secondary	Percent Change in Pressure Pain Threshold Between Baseline and End of Placebo Treatment and Between Baseline to End of LDN Treatment.	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.	Baseline to end of placebo (2 weeks + 4 weeks) and baseline to end of LDN (2 weeks + 12 weeks)	No
Secondary	Percent Change in Heat Pain Sensitivity Between Baseline and End of Placebo Treatment and Between Baseline to End of LDN Treatment.	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.	Baseline to end of placebo (2 weeks + 4 weeks) and baseline to end of LDN (2 weeks + 12 weeks)	No