Placebo-controlled, pharmacological clinical trial to evaluate the effectiveness, cost-utility and neurobiological effects Naltrexone in patients with fibromyalgia

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) - INNOVA Project

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-002534-16-ES

Enrollment

120

Registered

2021-08-12

Start date

2021-10-15

Completion date

Unknown

Last updated

2021-10-26

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

Conditions

Fibromyalgia MedDRA version: 20.0 Level: PT Classification code 10048439 Term: Fibromyalgia System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Interventions

Product Name: Naltrexone Pharmaceutical Form: Film-coated tablet INN or Proposed INN: NALTREXONE HYDROCHLORIDE Other descriptive name: NALTREXONE HYDROCHLORIDE Concentration unit: mg milligram(s) Conc

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Women between 18 and 70 years old. 2. FM diagnosis according to ACR 2016 criteria. 3. Report musculoskeletal pain at least moderate (> 4 out of 10) during the last 6 months. 4. Comprehension of Spanish. 5. Written informed consent of the patient himself. * Additional inclusion criteria for the biomarker substudy 1. Be right-handed (for neuroimaging tests). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20

Exclusion criteria

Exclusion criteria: 1. Opioid treatment in the past 6 months. 2. Diagnosis of severe medical / psychiatric illnesses (eg, cancer, severe depressive disorder, psychotic disorder, and schizophrenia). 3. Being pregnant (or planning to be during the study period) or breast-feeding. 4. Known allergy to Naltrexone or Naloxone. 5. Hematological disorders. 6. Abnormal liver function. 7. Take anticoagulant medication. 8. Consume alcohol during the study period. 9. Participate in another clinical trial. * Additional exclusion criteria biomarker substudy 1. Presence of other comorbid rheumatologic disorders (eg, rheumatoid arthritis, lupus) 2. Fever (> 38ºC) or infection in the last 2 weeks. 3. Vaccination last 4 weeks. 4. Take drugs with anti-inflammatory effects in the 72 hours prior to blood / neuroimaging. 5. Phobia of needles; inability to be evaluated by MRI (due to claustrophobia, metal implants, pacemakers, etc.). 6. BMI> 36kg / m2. 7. Consume> 8 units of caffeine per day. 8. Smoking> 10 cigarettes / day.

Design outcomes

Primary

Measure	Time frame
Primary end point(s): Pain intensity perception at the current moment (Pain Monitor app) Pain and the rest of the variables can fluctuate over the days depending on the stressors in the environment and, therefore, evaluating retrospectively introduces memory biases. Retrospective evaluation causes an overestimation of symptoms, which can be avoided by frequent evaluations of the Present symptoms, resulting in possible fatigue or saturation of the participants in their respective evaluations. In contrast, prospective and repeated evaluation over time substantially improves the precision, reliability, and quality of research, in addition to adding a traditionally low value such as ecological validity to psychopathological research. Smartphone apps are very easy to use, are easily accepted by chronic pain patients, and compliance rates with the use of mobile technology at all ages are around 75%. We will use the Pain Monitor® app, validated in an empirical study for use on Android smartphones, to evaluate daily (twice a day, one in the morning and one in the afternoon) the intensity of pain, the interference of pain in daily activities , fatigue, anxiety, depression, sleep, activity levels, and adverse effects of medications during the treatment period. Thanks to a collaboration agreement with Dr. Azucena García Palacios of the Jaume I University of Castelló, we will be able to use the app for free and the information collected will be stored on the UJI's servers. The Pain Monitor® app has been developed by a team of researchers from the UJI, with the collaboration of the non-profit medical team of the Pain Unit of the Vall d'Hebron University Hospital, for research purposes and is protected, by Therefore, for all purposes, to the provisions of article 37 of the Intellectual Property Law. It is not currently in commercial use. The content of the app, in addition to having been created by specialists in the management of chronic pain according to the recommendations of	—

Measure

Time frame

Primary end point(s): Pain intensity perception at the current moment (Pain Monitor app) Pain and the rest of the variables can fluctuate over the days depending on the stressors in the environment and, therefore, evaluating retrospectively introduces memory biases. Retrospective evaluation causes an overestimation of symptoms, which can be avoided by frequent evaluations of the Present symptoms, resulting in possible fatigue or saturation of the participants in their respective evaluations. In contrast, prospective and repeated evaluation over time substantially improves the precision, reliability, and quality of research, in addition to adding a traditionally low value such as ecological validity to psychopathological research. Smartphone apps are very easy to use, are easily accepted by chronic pain patients, and compliance rates with the use of mobile technology at all ages are around 75%. We will use the Pain Monitor® app, validated in an empirical study for use on Android smartphones, to evaluate daily (twice a day, one in the morning and one in the afternoon) the intensity of pain, the interference of pain in daily activities , fatigue, anxiety, depression, sleep, activity levels, and adverse effects of medications during the treatment period. Thanks to a collaboration agreement with Dr. Azucena García Palacios of the Jaume I University of Castelló, we will be able to use the app for free and the information collected will be stored on the UJI's servers. The Pain Monitor® app has been developed by a team of researchers from the UJI, with the collaboration of the non-profit medical team of the Pain Unit of the Vall d'Hebron University Hospital, for research purposes and is protected, by Therefore, for all purposes, to the provisions of article 37 of the Intellectual Property Law. It is not currently in commercial use. The content of the app, in addition to having been created by specialists in the management of chronic pain according to the recommendations of

—

Secondary

Measure	Time frame
Secondary end point(s): The secondary variables will be evaluated, recorded and stored in the REDCap platform, in order to facilitate the management, security and analysis of the study data. The battery of instruments that will be used to measure these variables is detailed below: - Revised Fibromyalgia Impact Questionnaire (FIQR). Questionnaire on physical function, global impact and severity of symptoms associated with FM. - Depression Anxiety Stress Scales-21 (DASS-21). Scale designed to evaluate depression, anxiety and stress in clinical and non-clinical samples. - Multidimensional Inventory of Subjective Cognitive Impairment (MISCI). Inventory to evaluate fibrofog in FM patients. - The 12-item interviewer administered version of the World Health Organization Disability Assessment Schedule 2.0 (12-item WHODAS 2.0). Scale to evaluate the level of difficulty or limitation that a person has experienced in each activity presented during the last year. - The Generalized Anxiety Disorder 7-item scale (GAD-7). Questionnaire that measures the symptoms of generalized anxiety (pathological concern). This instrument has been used in other studies for FM. - The 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) generalized pain index and (2) symptom severity scale. A total FM score is obtained, with higher values ??indicating greater severity (range: 0 to 31 points) - EuroQoL-5D (EQ-5D-5L). Health-related quality of life assessment instrument. It is made up of two parts: (1) difficulties in mobility, self-care, pain / discomfort and anxiety / depression; and (2) current state of health (visual scale from 0 to 100). - Client Service Receipt Inventory (CSRI). Retrospective collection notebook on the use of health and social services during the last 12 months. - Patient Global and Specific Impression of Chan	—

Measure

Time frame

Secondary end point(s): The secondary variables will be evaluated, recorded and stored in the REDCap platform, in order to facilitate the management, security and analysis of the study data. The battery of instruments that will be used to measure these variables is detailed below: - Revised Fibromyalgia Impact Questionnaire (FIQR). Questionnaire on physical function, global impact and severity of symptoms associated with FM. - Depression Anxiety Stress Scales-21 (DASS-21). Scale designed to evaluate depression, anxiety and stress in clinical and non-clinical samples. - Multidimensional Inventory of Subjective Cognitive Impairment (MISCI). Inventory to evaluate fibrofog in FM patients. - The 12-item interviewer administered version of the World Health Organization Disability Assessment Schedule 2.0 (12-item WHODAS 2.0). Scale to evaluate the level of difficulty or limitation that a person has experienced in each activity presented during the last year. - The Generalized Anxiety Disorder 7-item scale (GAD-7). Questionnaire that measures the symptoms of generalized anxiety (pathological concern). This instrument has been used in other studies for FM. - The 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) generalized pain index and (2) symptom severity scale. A total FM score is obtained, with higher values ??indicating greater severity (range: 0 to 31 points) - EuroQoL-5D (EQ-5D-5L). Health-related quality of life assessment instrument. It is made up of two parts: (1) difficulties in mobility, self-care, pain / discomfort and anxiety / depression; and (2) current state of health (visual scale from 0 to 100). - Client Service Receipt Inventory (CSRI). Retrospective collection notebook on the use of health and social services during the last 12 months. - Patient Global and Specific Impression of Chan

—

Countries

Spain

Contacts

Public ContactJoana Claverol

Fundació Sant Joan de Déu

joana.claverol@sjd.es

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026