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| ID | Type | Description | Link |
|---|---|---|---|
| 8948 |
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| Name | Class |
|---|---|
| American Fibromyalgia Syndrome Association | OTHER |
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Dose Naltrexone first | Experimental | LDN first, then placebo. |
|
| Placebo - sugar pill first | Placebo Comparator | Placebo first, then LDN. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low Dose Naltrexone | Drug | 3-4.5mg Naltrexone once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Jarred Younger | Stanford University | Sub-Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University School of Medicine | Stanford | California | 94305 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23359310 | Derived | 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. |
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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.
325 women completed an online web survey
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| ID | Title | Description |
|---|---|---|
| FG000 | Low Dose Naltrexone First | Low Dose Naltrexone (LDN) followed by placebo. LDN at 3-4.5mg, once a day. Placebo (sugar pill) once a day. |
| FG001 | Placebo - Sugar Pill First | Placebo first, followed by LDN. Placebo (sugar pill) once a day. LDN at 3-4.5mg, once a day. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
2 participants in the low dose naltrexone group did not have data to analyze (1 withdrew by patient choice, 1 had a malfunction with the data collection device)
1 participant in the placebo condition did not have data to analyze (withdrew by patient choice)
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| ID | Title | Description |
|---|---|---|
| BG000 | Low Dose Naltrexone | |
| BG001 | Placebo - Sugar Pill | |
| BG002 | Total |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | All completers | Posted | Mean | 95% Confidence Interval | percentage change from baseline to final | Baseline to end of placebo (2 weeks + 4 weeks) and baseline to end of LDN (2 weeks + 12 weeks) |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Low Dose Naltrexone | All participants during the Low Dose Naltrexone condition |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vivid Dreams | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jarred Younger, PhD | Stanford University School of Medicine | 650-724-2795 | jyounger@stanford.edu |
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| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| D018923 | Persian Gulf Syndrome |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
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| ID | Term |
|---|---|
| D009271 | Naltrexone |
| ID | Term |
|---|---|
| D009270 | Naloxone |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 |
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| Placebo - sugar pill | Drug | Placebo pill once daily |
|
| 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. | 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) |
| 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) |
| 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) |
Total of all reporting groups
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 |
| Placebo - Sugar Pill |
All participants during the placebo condition |
|
|
| 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. | All completers | Posted | Mean | 95% Confidence Interval | percentage change from baseline | Baseline to end of placebo (2 weeks + 4 weeks) and baseline to end of LDN (2 weeks + 12 weeks) |
|
|
|
| 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. | All completers | Posted | Mean | 95% Confidence Interval | percentage change from baseline | Baseline to end of placebo (2 weeks + 4 weeks) and baseline to end of LDN (2 weeks + 12 weeks) |
|
|
|
| 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. | All completers | Posted | Mean | 95% Confidence Interval | percentage change from baseline to final | Baseline to end of placebo (2 weeks + 4 weeks) and baseline to end of LDN (2 weeks + 12 weeks) |
|
|
|
| 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. | All completers | Posted | Mean | 95% Confidence Interval | percentage change from baseline to final | Baseline to end of placebo (2 weeks + 4 weeks) and baseline to end of LDN (2 weeks + 12 weeks) |
|
|
|
| 0 |
| 28 |
| 20 |
| 28 |
| EG001 | Placebo - Sugar Pill | All participants during the placebo condition | 0 | 28 | 7 | 28 |
| Headache | General disorders | Systematic Assessment |
|
| Nausea/Upset Stomach | General disorders | Systematic Assessment |
|
| Nightmares | General disorders | Systematic Assessment |
|
| Insomnia | General disorders | Systematic Assessment |
|
| Dry mouth or throat | General disorders | Systematic Assessment |
|
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| D009422 |
| Nervous System Diseases |
| D009784 | Occupational Diseases |
| D000067398 | War-Related Injuries |
| D014947 | Wounds and Injuries |
| Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |