Effects of Low Dose Naltrexone in Fibromyalgia

NCT00568555 | Completed Results

• 2 other identifiers: SU-10232007-7568948
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia; Persian Gulf Syndrome

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (4)

• Percent Change in Sleep Quality Scores Between Baseline to End of Placebo Treatment and Between Baseline to End of LDN Treatment.

  Baseline to end of placebo (2 weeks + 4 weeks) and baseline to end of LDN (2 weeks + 12 weeks)

• Percent Change in Fatigue Scores Between Baseline to End of Placebo Treatment and Between Baseline to End of LDN Treatment.

  Baseline to end of placebo (2 weeks + 4 weeks) and baseline to end of LDN (2 weeks + 12 weeks)

• Percent Change in Pressure Pain Threshold Between Baseline and End of Placebo Treatment and Between Baseline to End of LDN Treatment.

  Baseline to end of placebo (2 weeks + 4 weeks) and baseline to end of LDN (2 weeks + 12 weeks)

• Percent Change in Heat Pain Sensitivity Between Baseline and End of Placebo Treatment and Between Baseline to End of LDN Treatment.

  Baseline to end of placebo (2 weeks + 4 weeks) and baseline to end of LDN (2 weeks + 12 weeks)

Study Arms (2)

Low Dose Naltrexone first

EXPERIMENTAL

LDN first, then placebo.

Drug: Low Dose Naltrexone; Drug: Placebo - sugar pill

Placebo - sugar pill first

PLACEBO COMPARATOR

Placebo first, then LDN.

Drug: Low Dose Naltrexone; Drug: Placebo - sugar pill

Interventions

Low Dose Naltrexone DRUG

3-4.5mg Naltrexone once daily

Low Dose Naltrexone first; Placebo - sugar pill first

Placebo - sugar pill DRUG

Placebo pill once daily

Low Dose Naltrexone first; Placebo - sugar pill first

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Any known allergy to naltrexone or naloxone. Actual or planned pregnancy.

Sponsors & Collaborators

• Stanford University: lead
• American Fibromyalgia Syndrome Association: collaborator

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Related Publications (1)

• 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.

  PMID: 23359310 DERIVED

MeSH Terms

Conditions

Fibromyalgia; Persian Gulf Syndrome

Interventions

Naltrexone

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Occupational Diseases; War-Related Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Jarred Younger, PhD
• Organization: Stanford University School of Medicine

jyounger@stanford.edu

650-724-2795

Study Officials

• Jarred Younger

  Stanford University

  SUB INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 4, 2007
• First Posted: December 6, 2007
• Study Start: June 1, 2007
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: October 21, 2015
• Results First Posted: October 21, 2015

Record last verified: 2015-09

Locations

US (1)