Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02107014
Other study ID # 29911
Secondary ID
Status Recruiting
Phase N/A
First received April 1, 2014
Last updated April 7, 2014
Start date March 2014
Est. completion date June 2015

Study information

Verified date April 2014
Source Stanford University
Contact Jarred Younger, PhD
Phone 650-721-1988
Email youngerlab@stanford.edu
Is FDA regulated No
Health authority United States: Food and Drug AdministrationUnited States: Federal GovernmentUnited States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date June 2015
Est. primary completion date December 2014
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Intervention Model: Crossover Assignment, Masking: Single Blind (Subject)


Related Conditions & MeSH terms


Intervention

Drug:
Low Dose Naltrexone

Placebo


Locations

Country Name City State
United States Stanford University School of Medicine Palo Alto California

Sponsors (1)

Lead Sponsor Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in average daily pain (0-100 Visual Analogue Scale) correlated with change in immune markers Change in pain from placebo period to end of drug period correlated with change in immune markers from placebo to end of drug period End of placebo compared to end of drug period. Total comparison period is 12 weeks. No
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05659862 - Digitally Assisted Behavioral Physical Activity Intervention in Fibromyalgia N/A
Recruiting NCT03207828 - Testing Interventions for Patients With Fibromyalgia and Depression N/A
Completed NCT03042728 - Impact of Inclusion of a Therapy Dog Visit as Part of the Fibromyalgia Treatment Program N/A
Recruiting NCT06097091 - Effects and Mechanisms of Pain Neuroscience Education in Patients With Fibromyalgia N/A
Recruiting NCT04554784 - Effectiveness of Bowen Therapy for Pain Management in Patients With Fibromyalgia N/A
Completed NCT03300635 - Metabolism, Muscle Function and Psychological Factors in Fibromyalgia N/A
Recruiting NCT06166563 - Exercise, Irritable Bowel Syndrome and Fibromyalgia N/A
Completed NCT03166995 - Postural Exercises in Women With Fibromyalgia N/A
Completed NCT03227952 - Sensory Stimulation in Fibromyalgia N/A
Recruiting NCT06237595 - Vagus Nerve Stimulation in Fibromyalgia N/A
Completed NCT01888640 - Fibromyalgia Activity Study With Transcutaneous Electrical Nerve Stimulation (FAST) N/A
Completed NCT03641495 - Pain Education and Therapeutic Exercise for Fibromyalgia N/A
Recruiting NCT05581628 - FREQUENCY OF FIBROMYALGIA IN PATIENTS WITH CELIAC DISEASE
Active, not recruiting NCT05128162 - Open-label Study to Assess the Safety and Efficacy of Psilocybin With Psychotherapy in Adult Participants With Fibromyalgia Phase 2
Completed NCT04674878 - Comparison of Muscle Energy Techniques and Breathing Exercises for Functional Improvement in Fibromyalgia N/A
Active, not recruiting NCT04084795 - Augmentation of EMDR With tDCS in the Treatment of Fibromyalgia N/A
Completed NCT03129906 - Impact of the Restriction of Sources of Gluten in Fibromyalgia Patients N/A
Completed NCT05058911 - Exposure-based Cognitive Behavior Therapy vs Traditional Cognitive Behavior Therapy for Fibromyalgia N/A
Recruiting NCT04571528 - Effectiveness of VIRTUAL FIBROWALK STUDY N/A
Recruiting NCT04571853 - New Educational Tool for FM N/A