N/A Completed N=9 Single-blind Basic Science

Low Dose Naltrexone (LDN) Immune Monitoring

Fibromyalgia

Source: ClinicalTrials.gov NCT02107014 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2017

Primary outcomePrimary: Change in IL-1α From Baseline. — 3.56; 3.88 pg/mL — p=.576

Summary

We have found that low dose naltrexone (LDN) can substantially reduce pain associated with fibromyalgia syndrome. We believe LDN may work via novel anti-inflammatory channels. The purpose of this study is to determine if LDN lowers inflammatory markers in individuals with fibromyalgia.

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in IL-1α From Baseline.	3.56; 3.88	.576
PRIMARY Change in IL-1β From Baseline.	0.33; 0.26	0.010 sig
PRIMARY Change in IL-1Ra From Baseline.	2433.11; 2004.48	.008 sig
PRIMARY Change in IL-2 From Baseline.	23.21; 21.32	.015 sig
PRIMARY Change in IL-4 From Baseline.	20.70; 19.00	.007 sig
PRIMARY Change in IL-5 From Baseline.	1.94; 4.57	.016 sig
PRIMARY Change in IL-6 From Baseline.	10.22; 5.87	<0.001 sig
PRIMARY Change in IL-7 From Baseline.	10.18; 10.28	0.212
PRIMARY Change in IL-8 From Baseline.	0; 0	—
PRIMARY Change in IL-9 From Baseline.	0; 0	—
PRIMARY Change in IL-10 From Baseline.	6.01; 10.11	0.008 sig
PRIMARY Change in IL-12p40 From Baseline.	6.91; 6.43	0.004 sig
PRIMARY Change in IL-12p70 From Baseline.	1.82; 1.69	<0.001 sig
PRIMARY Change in IL-13 From Baseline.	0.66; 0.66	0.047 sig
PRIMARY Change in IL-15 From Baseline.	11.08; 8.71	0.002 sig
PRIMARY Change in IL-17A From Baseline.	5.03; 3.40	0.003 sig
PRIMARY Change in IL-17F From Baseline.	0.95; 0.89	0.191
PRIMARY Change in IL-18 From Baseline.	9.61; 6.66	0.088
PRIMARY Change in IL-21 From Baseline.	29.96; 327.07	0.478
PRIMARY Change in IL-23 From Baseline.	0; 0	—
PRIMARY Change in IL-31 From Baseline.	0; 0	—
PRIMARY Change in IL-27 From Baseline.	86.51; 96.39	0.016 sig
PRIMARY Change in LIF From Baseline.	4.93; 4.49	0.025 sig
PRIMARY Change in G-CSF From Baseline.	37.78; 35.67	0.012 sig
PRIMARY Change in GM-CSF From Baseline.	5779.44; 6377.62	0.426
PRIMARY Change in MIP-1α From Baseline.	5.66; 3.60	0.042 sig
PRIMARY Change in SDF-1α From Baseline.	148.14; 123.19	0.708
PRIMARY Change in IP-10 From Baseline.	6.01; 5.28	0.558
PRIMARY Change in Eotaxin From Baseline.	36.54; 29.95	0.350
PRIMARY Change in RANTES From Baseline.	57.00; 57.27	0.655
PRIMARY Change in MIP-1β From Baseline.	58.52; 51.08	0.248
PRIMARY Change in MCP-1 From Baseline.	24.30; 25.38	0.128
PRIMARY Change in MCP-3 From Baseline.	31.52; 25.30	0.065
PRIMARY Change in MIG From Baseline.	47.81; 35.98	0.962
PRIMARY Change in TRAIL From Baseline.	23.42; 12.95	0.402
PRIMARY Change in CD40L From Baseline.	41.97; 35.78	0.201
PRIMARY Change in TGF-α From Baseline.	1.42; 0.58	0.016 sig
PRIMARY Change in TGF-β From Baseline.	9.40; 7.80	0.006 sig
PRIMARY Change in IFN-α From Baseline.	4.99; 4.15	0.007 sig
PRIMARY Change in IFN-β From Baseline.	24.04; 19.10	0.038 sig
PRIMARY Change in IFN-γ From Baseline.	11.42; 9.29	0.032 sig
PRIMARY Change in TNF-α From Baseline.	124.36; 116.04	0.002 sig
PRIMARY Change in TNF-β From Baseline.	0; 0	—
PRIMARY Change in PIGF-1 From Baseline.	1.75; 2.09	0.508
PRIMARY Change in SCF From Baseline.	7.53; 5.41	0.119
PRIMARY Change in HGF From Baseline.	187.27; 189.33	0.326
PRIMARY Change in VEGF-D From Baseline.	2.62; 3.30	0.753
PRIMARY Change in VEGF From Baseline.	80.95; 70.70	0.067
PRIMARY Change in NGF From Baseline.	12.24; 10.50	0.080
PRIMARY Change in EGF From Baseline.	5.23; 3.23	0.639
PRIMARY Change in FGF-β From Baseline.	0; 0	—
PRIMARY Change in M-CSF From Baseline.	0; 0	—
PRIMARY Change in BDNF From Baseline.	777.60; 717.98	0.945
PRIMARY Change in ICAM-1 From Baseline.	2670.81; 2820.63	0.038 sig
PRIMARY Change in VCAM-1 From Baseline.	30876.40; 32156.99	0.281
PRIMARY Change in ENA-78 From Baseline.	134.64; 83.36	0.030 sig
PRIMARY Change in PDGF-BB From Baseline.	179.89; 150.29	0.948
PRIMARY Change in PAI-1 From Baseline.	15086.40; 15536.99	0.610
PRIMARY Change in Leptin From Baseline.	3991.44; 4128.32	0.893
PRIMARY Change in Resistin From Baseline.	1831.26; 1942.47	0.041 sig
PRIMARY Change in GROa From Baseline.	0; 0	—
PRIMARY Change in FaSL From Baseline.	0; 0	—
PRIMARY Change in IL-22 From Baseline.	194.59; 220.62	0.967
PRIMARY Change in Pain From Baseline.	51.149; 43.286	<0.001 sig
PRIMARY Change in Overall Fibromyalgia Symptoms From Baseline.	55.653; 45.506	<0.001 sig

Eligibility Criteria

Inclusion Criteria

Females age 18-65
Meets criteria for 1990 ACR criteria for fibromyalgia
Able to receive venous blood draw twice a week for 16 weeks
Sufficient symptom variability during baseline report
Patient completes daily report during 2 week baseline period at least 80% completion rate.

Exclusion Criteria

Opioid use
Significant psychological comorbidity that in the discretion of the investigator compromises study integrity
Location prohibits travel to Stanford
Blood or clotting disorder
Rheumatologic or autoimmune disease
Acute infection
Baseline blood ESR >60, CRP greater than 3.0mg/L, positive rheumatoid factor, or positive ANA
Use of blood thinning medication
Pregnant or currently planning to become pregnant
Current use of aspirin, ibuprofen, naproxen, or other confounding-anti-inflammatory medication as part of regular medication regimen.
Known allergy to Naltrexone or Naloxone
Currently participating in another treatment-based research study
Self-reported inability to refrain from alcohol for the duration of the study period

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02107014). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.