Randomized Controlled Trial Clinical Trial
— INNOVAOfficial title:
12-month Randomized, Double-blind, Placebo-controlled, Pharmacological Clinical Trial to Evaluate the Effectiveness, Cost-utility and Neurobiological Effects of Low-dose Naltrexone in Patients With Fibromyalgia (INNOVA Project)
Verified date | April 2024 |
Source | Fundació Sant Joan de Déu |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Background: Low-dose naltrexone (LDN) may be useful in managing the pathologies that alter inflammatory markers, such as Crohn's disease or fibromyalgia (FM). The anti-inflammatory effect of LDN should be produced through the inhibition of Toll-like receptor 4 activity expressed in the membrane of various immune system cells (e.g. microglia). Conversely, due to a rebound effect, LDN could exercise an analgesic effect that strengthens the endogenous inhibitory system. According to this hypothesis, the low-intensity and intermittent blocking of the opioid receptors generated by LDN should induce a compensatory mechanism that should facilitate an increase in the production of endogenous opioids and greater sensitivity of the system to their effects. To date, the effects of LDN in patients with FM have been evaluated through crossover studies that have yielded promising results. Given that the studies conducted up to now have had small sample sizes and crossover designs, and given that there are still no studies in which its potential cost-utility is assessed, studies with greater methodological rigor and larger samples are necessary to confirm the effectiveness of LDN in FM. Jointly evaluating the effectiveness and cost-utility, the changes in metabolites in certain areas of the brain, and systemic inflammatory markers potentially linked to the etiopathogenesis of FM, should allow us to gain a more detailed knowledge of the neurobiological mechanisms underlying the effectiveness of LDN in this population. Objectives: To evaluate the effectiveness and safety of LDN in patients with FM and analyse its cost-utility both from the government and the healthcare perspective at 1-year follow-up. Brain metabolites and systemic inflammatory biomarkers will be included to evaluate neurobiological mechanisms behind LDN therapeutic effects. Design: Randomized, Controlled Trial. Centre: Parc Sanitari Sant Joan de Déu (St. Boi de Llobregat, Spain). Participants: 120 patients with FM will be randomly assigned to LDN (4.5mg/day) or placebo. Main outcome measure: Pain severity using Ecological Momentary Assessment. Secondary outcomes: functionality, affective symptoms, fibrofog, quality of life. Costs and QALYs will be also calculated. Biomarkers: 50% of the patients will be scanned at baseline and at week 12 for changes in brain metabolites related to neuroinflammation and central sensitization. Immune-inflammatory markers in serum will also be evaluated.
Status | Active, not recruiting |
Enrollment | 99 |
Est. completion date | December 31, 2024 |
Est. primary completion date | October 31, 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 70 Years |
Eligibility | General Inclusion Criteria: - Female between 18 and 70 years old - Patients diagnosed of FM according to ACR 2016 criteria - Chronic widespread pain for at least 6 months ranked = 4 out of 10; - Understand Spanish; - Written informed written consent; General Exclusion Criteria: - Treatment with opiates in last 3 months; - Diagnosis of severe medical/psychiatric disorders (e.g. cancer, severe depression, psychotic disorder, schizophrenia); - Being pregnant (or planning a pregnancy during the study period) or breastfeeding; - Known allergy to naltrexone or naloxone; - Hematological disorders; - Abnormal hepatic function; - Taking anticoagulant medication; - Alcohol consume during the study period - Participation in other clinical trials; Additional inclusion criteria for biomarker sub-study: Right-handed (for the neuroimaging tests) Additional exclusion criteria for biomarker sub-study: Comorbid rheumatologic illnesses (e.g. rheumatoid arthritis, lupus); fever (> 38ºC) or infection in the last 2 weeks; vaccination in the last 4 weeks; Take drugs with anti-inflammatory effects in the 72h prior to blood / neuroimaging; taking cortisone or anti-cytokine therapy; needle phobia; inability to be scanned (due to claustrophobia, metal implants, pacemakers, etc.); Body Mass Index (BMI) > 36 kg/m2; consumption of > 8 units of caffeine per day; smoking > 10 cigarettes/day; acute pain not-related to FM on the day of the scan (e.g. headache, back pain). |
Country | Name | City | State |
---|---|---|---|
Spain | Parc Sanitari Sant Joan de Déu (PSSJD) | Sant Boi De Llobregat | Barcelona |
Lead Sponsor | Collaborator |
---|---|
Fundació Sant Joan de Déu | Carlos III Health Institute |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | EuroQoL (EQ-5D-5L) | Instrument for evaluating health-related quality of life. The EQ-5D-5L scores will be used to calculate the QualityAdjusted Life Years (QALYs) for the cost-utility analysis | Through study completion, an average of 1 year | |
Other | Client Service Receipt Inventory (CSRI) | The version used in this study is designed to retrospectively collect information on the use of health and social services during the previous 12 months. This instrument does not provide total or sub-scale scores, only collects information about use of services and medication consumption. | Through study completion, an average of 1 year | |
Other | Patient Global and Specific Impression of Change (PGIC/PSIC) | Items scored on a 7-point Likert scale (from 1 "much better" to 7 "much worse") | Through study completion, an average of 1 year | |
Other | ACTTION AE | It is a reporting checklist used to measure safety and benefit-risk of a clinical trial. | Through study completion, an average of 1 year | |
Other | The Pain Monitor® app | It was validated in an empirical study for use on Android smartphones. It will be used to assess daily (twice a day) the level of pain, fatigue, etc. during the treatment period. | Through study completion, an average of 1 year | |
Other | Socio-demographic questionnaire | Gender, date of birth, marital status, living arrangements, educational level and work status. | Baseline | |
Other | 12-item WHODAS 2.0 | The 12-item interviewer administered version of the World Health Organization Disability Assessment Schedule 2.0 can be used algorithmically for the probable diagnosis of a depressive disorder, or as a continuous measure of scores ranging from 0 to 27, with cutoff points of 5, 10, 15 and 20, which set the levels of symptoms of depression as mild, moderate, moderately severe or severe. | Baseline | |
Other | Generalized Anxiety Disorder 7-item scale (GAD-7) | Questionnaire that measures generalized anxiety symptoms (pathological worry). This instrument has been used in other studies for FM. | Baseline | |
Other | Fibromyalgia Survey Diagnostic Criteria (FSDC) | Scale that assesses the main symptoms of FM according to the latest revision of the American College of Rheumatology (ACR) criteria. This instrument includes 2 subscales: (1) the generalized pain index and (2) the symptom severity scale. A total FM score is obtained, with higher values indicating greater severity (range: 0 to 31 points). | Baseline | |
Primary | Pain intensity | -Numerical Rating Scale-NRS- from 0 (no pain) to 10 (worst possible pain) | Through study completion, an average of 1 year | |
Secondary | Revised Fibromyalgia Impact Questionnaire (FIQR) | 21-item questionnaire on physical function, overall impact and severity of the symptoms associated with FM. Total scores can range from 0 (no impairment) to (maximum impairment) memory/attentional problems, quality of sleep) | Through study completion, an average of 1 year | |
Secondary | Depression Anxiety Stress Scale (DASS-21) | Scale of 21 items created to assess symptoms of depression, anxiety and stress. Each subscale (Depressión, Anxiety and Stress) includes 7 items with scores ranging from 0 to 21. Higher scores indicate higher symptom severity. | Through study completion, an average of 1 year | |
Secondary | Multidimensional Inventory of Subjective Cognitive Impairment (MISCI) | 10-item measure of subjective cognitive dysfunction in FM. total score ranges from 10 to 50, where lower scores indicate higher cognitive dysfunction. | Through study completion, an average of 1 year |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04027634 -
Feasibility and Preliminary Effect of Baduanjin Program for People Diagnosed With Schizophrenia
|
N/A | |
Completed |
NCT02644096 -
Rehabilitation of Patients After THR - Based on Patients´Selfrated Health
|
Phase 1 | |
Completed |
NCT03284892 -
Screening and Intervention of Postextubation Dysphagia
|
N/A | |
Not yet recruiting |
NCT06412133 -
Conversations in Light and Shadow: Assessing Phototherapy's Impact on Breast Cancer Patients
|
N/A | |
Completed |
NCT05299060 -
Effectiveness of Cyanoacrylate Glue in the Fixation of Midline and Peripherally Inserted Central Catheters in Hospitalized Adult Patients: Randomised Clinical Trial (CIANO-ETI)
|
N/A | |
Recruiting |
NCT06150313 -
Efficacy of the Mediational Intervention for Sensitizing Caregivers for Teachers and Self-Administered Versions
|
N/A | |
Not yet recruiting |
NCT05939986 -
A Protocol for a Virtual Reality Exposure Therapy for Fear of Flying.
|
N/A | |
Completed |
NCT04071444 -
Exploring the Effects of a Baduanjin Program on the Symptoms of Constipation in Patients With Schizophrenia Spectrum
|
N/A | |
Not yet recruiting |
NCT06091501 -
LIVING - Physical Activity in a Self-management Program Among Persons With Type 2 Diabetes
|
N/A | |
Completed |
NCT03008668 -
A Pilot Trial of Acupuncture for Knee Osteoarthritis With Differential Functional Status of Acupoints
|
N/A | |
Completed |
NCT00057070 -
Facilitating Implementation of the PHS Smoking Cessation Guidelines - RESET
|
N/A | |
Completed |
NCT04545346 -
The Potential of a Low Glutamate Diet as a Treatment for Pediatric Epilepsy
|
N/A | |
Completed |
NCT05069844 -
Preoperative Gum Chewing for Different Durations to Prevent Sore Throat After Endotracheal Intubation
|
N/A | |
Completed |
NCT06460935 -
The Effect of Online Sexual Health Training Given to Nursing Students on Knowledge, Attitude and Self-Efficacy
|
N/A | |
Recruiting |
NCT03302572 -
Effectiveness Brief Information Advanced Directives Primary Care
|
N/A | |
Recruiting |
NCT05634122 -
Efficacy of ACT in Patients Scheduled for Lumbar Spine Surgery
|
N/A | |
Completed |
NCT04650906 -
A Feasibility Study for Evaluating the Effectiveness of Mindhelper - a National Youth Mental Health Promotion Website
|
N/A | |
Recruiting |
NCT05527158 -
Traditional Chinese Yijinjing Exercise on Hand Dysfunction in Rheumatoid Arthritis Patients
|
N/A | |
Recruiting |
NCT06402552 -
Comparing Bp-MRI and Mp-MRI for Prostate Cancer Screening Accuracy
|
N/A | |
Not yet recruiting |
NCT06330233 -
Different Amounts of Moxibustion in the Treatment of DPN: A Clinical RCT Study
|
N/A |