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Effects of Low Dose Naltrexone in Fibromyalgia

Primary Purpose

Fibromyalgia, Persian Gulf Syndrome

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Low Dose Naltrexone
Placebo - sugar pill
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Stanford University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Low Dose Naltrexone first

Placebo - sugar pill first

Arm Description

LDN first, then placebo.

Placebo first, then LDN.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
December 4, 2007
Last Updated
September 21, 2015
Sponsor
Stanford University
Collaborators
American Fibromyalgia Syndrome Association
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1. Study Identification

Unique Protocol Identification Number
NCT00568555
Brief Title
Effects of Low Dose Naltrexone in Fibromyalgia
Official Title
Effects of Low Dose Naltrexone in Fibromyalgia
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
American Fibromyalgia Syndrome Association

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia, Persian Gulf Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
53 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low Dose Naltrexone first
Arm Type
Experimental
Arm Description
LDN first, then placebo.
Arm Title
Placebo - sugar pill first
Arm Type
Placebo Comparator
Arm Description
Placebo first, then LDN.
Intervention Type
Drug
Intervention Name(s)
Low Dose Naltrexone
Intervention Description
3-4.5mg Naltrexone once daily
Intervention Type
Drug
Intervention Name(s)
Placebo - sugar pill
Intervention Description
Placebo pill once daily
Primary Outcome Measure Information:
Title
Percent Change in Pain Scores Between Baseline to End of Placebo Treatment and Between Baseline to End of LDN Treatment.
Description
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.
Time Frame
Baseline to end of placebo (2 weeks + 4 weeks) and baseline to end of LDN (2 weeks + 12 weeks)
Secondary Outcome Measure Information:
Title
Percent Change in Sleep Quality Scores Between Baseline to End of Placebo Treatment and Between Baseline to End of LDN Treatment.
Description
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.
Time Frame
Baseline to end of placebo (2 weeks + 4 weeks) and baseline to end of LDN (2 weeks + 12 weeks)
Title
Percent Change in Fatigue Scores Between Baseline to End of Placebo Treatment and Between Baseline to End of LDN Treatment.
Description
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.
Time Frame
Baseline to end of placebo (2 weeks + 4 weeks) and baseline to end of LDN (2 weeks + 12 weeks)
Title
Percent Change in Pressure Pain Threshold Between Baseline and End of Placebo Treatment and Between Baseline to End of LDN Treatment.
Description
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.
Time Frame
Baseline to end of placebo (2 weeks + 4 weeks) and baseline to end of LDN (2 weeks + 12 weeks)
Title
Percent Change in Heat Pain Sensitivity Between Baseline and End of Placebo Treatment and Between Baseline to End of LDN Treatment.
Description
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.
Time Frame
Baseline to end of placebo (2 weeks + 4 weeks) and baseline to end of LDN (2 weeks + 12 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jarred Younger
Organizational Affiliation
Stanford University
Official's Role
Sub-Investigator
Facility Information:
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23359310
Citation
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.
Results Reference
derived

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Effects of Low Dose Naltrexone in Fibromyalgia

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