Effects of Low Dose Naltrexone in Fibromyalgia

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00568555

Enrollment

Registered

2007-12-06

Start date

2007-06-30

Completion date

2010-01-31

Last updated

2015-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fibromyalgia, Persian Gulf Syndrome

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.

Interventions

DRUGLow Dose Naltrexone

3-4.5mg Naltrexone once daily

DRUGPlacebo - sugar pill

Placebo pill once daily

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
Percent Change in Pain 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)	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

Measure	Time frame	Description
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)	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.	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.
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)	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.	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.

Countries

United States

Participant flow

Recruitment details

325 women completed an online web survey

Pre-assignment details

Individuals were assessed for eligibility via web screening and phone screening prior to enrollment. Further eligibility (blood tests, questionnaires) assessed after enrollment; ineligible consented participants were withdrawn prior to assignment to groups.

Participants by arm

Arm	Count
Low Dose Naltrexone	14
Placebo - Sugar Pill	14
Total	28

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Withdrawal by Subject	1	1

Baseline characteristics

Characteristic	Placebo - Sugar Pill	Low Dose Naltrexone	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	0 Participants	0 Participants	0 Participants
Age, Categorical Between 18 and 65 years	14 Participants	14 Participants	28 Participants
Age, Continuous	42.3 years STANDARD_DEVIATION 13	43.8 years STANDARD_DEVIATION 13.4	42.7 years STANDARD_DEVIATION 12.9
Region of Enrollment United States	14 participants	14 participants	28 participants
Sex: Female, Male Female	14 Participants	14 Participants	28 Participants
Sex: Female, Male Male	0 Participants	0 Participants	0 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	20 / 28	7 / 28
serious Total, serious adverse events	0 / 28	0 / 28

Outcome results

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.