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CBD (Cannabidiol)/THC (Tetrahydrocannabinol) Solution as a Pharmacological Strategy for Patients With Fibromyalgia (FibroCann)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05283161
Recruitment Status : Not yet recruiting
First Posted : March 16, 2022
Last Update Posted : April 11, 2022
Sponsor:
Collaborator:
3F Clinical Trials LTDA
Information provided by (Responsible Party):
FG Brasil LTDA

Brief Summary:

Fibromyalgia is considered a chronic pain syndrome, non-inflammatory, of unknown etiology, which manifests itself in the musculoskeletal system in up to 2.5% of the general population, predominantly in females, mainly between 35 and 44 years old, having a direct impact on the quality of life of their patients (JUNIOR; GOLDENFUM; SIENA, 2012; HEYMANN et al., 2017). In 1990, eighteen (18) specific sites were defined as tender points which are used to better diagnose fibromyalgia (WOLFE et al., 2010). Due to its clinical and exclusion diagnosis, treatment usually starts late, which allows the progression of symptoms and corroborates its low efficiency in the long term (DE SOUSA BRAZ et al., 2011). Due to the ineffective results and significant side effects that conventional treatment with drugs such as antidepressants, analgesics and anti-inflammatory drugs can provide, patients, physicians and researchers are looking for new main or adjuvant treatments, pharmacological and non-pharmacological (DE SOUSA BRAZ et al. al., 2011). In this context, it has been seen that the use of Cannabis sativa as a therapeutic option in fibromyalgia is promising, especially in reducing the pain caused by the disease and also the adjuvant symptoms, such as depression and sleep disorders (YASSIN; ORON; ROBINSON, 2019). This result must occur due to the action of cannabinoids, such as CBD and THC, on cannabinoid receptors distributed in peripheral nerves, spinal cord and supraspinal region, sites responsible for the reception, transmission and perception of pain (STE-MARIE et al., 2012). Currently, cannabinoids are considered safe analgesics with considerable efficacy, which demonstrates potential as a therapeutic option in the treatment of chronic pain, particularly in patients refractory to other treatments (HAUSER et al., 2018). In addition to its action on the painful mechanisms of fibromyalgia, the antidepressant effects of Cannabis are of great value in the treatment of fibromyalgia. These effects are explained by the modulation on serotonin 5-HT1A receptors, which has its effect exerted especially by CBD (ESPEJO-PORRAS et al., 2013).

Considering that research has reported the effects of phytocannabinoids on the painful symptoms of fibromyalgia (HAUSER et al., 2018), the hypotheses of the present study are:

Primary hypothesis: The dose-response curve and ED50 for the primary outcome, which is related to pain intensity, will be determined in the dose range between 0.1 and 10mg/day. The sensation of pain will be significantly reduced in participants receiving oral solution containing CBD/THC 10mg/day compared to those who will receive placebo.

Secondary hypothesis: There will be a reduction in pain catastrophizing, as well as an improvement in the acceptance and action rate related to pain, a reduction in depression, an improvement in sleep latency and quality, a reduction in insomnia and an increase in the quality of life in patients treated with oral solution containing CBD/THC 10mg/day compared to those receiving placebo.

Supporting Hypothesis: The tested CBD/THC solution will show efficacy and safety with no serious adverse effects.


Condition or disease Intervention/treatment Phase
Fibromyalgia Drug: cannabidiol and tetrahydrocannabinol Drug: Placebo Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This single center clinical trial is a double-blinded, randomized, placebo-controlled and dose-response type, having a pre-randomization period (8 days prior to the beginning of the study), and a 120-day double-blind main period. Patients will be double-blind randomized in a 1 by 1 by 1 by 1 ratio to receive cannabidiol and tetrahydrocannabinol 1 by 1: (0.1 mg/ml) (10 research participants), cannabidiol and tetrahydrocannabinol 1 by 1 (1.0 mg/ml) (n=10), cannabidiol and tetrahydrocannabinol 1 by 1 (10 mg/ml) (10 research participants) and placebo (vehicle) (10 research participants). The administration will occur daily, once a day, during the night period, before going to bed and 30 minutes after the meal, during the next 120 days. The clinical study will have a baseline assessment (T0), one day before the start of the intervention with the solution. The tools will be reapplied after 15 (T1), 30 (T2), 60 (T3), 90 (T4) and 120 (T5) days of intervention.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: The placebo will match the study drug in odor, taste, color and appearance to ensure proper masking. Eligible patients included in the pre-randomization period will be double-blind randomized in a 1:1:1:1 ratio between the experimental groups, by a biostatistician who is not involved in data collection nor analysis, to receive the CBD/THC solution at doses of 0.1mg/day, 1mg/day, 10mg/day, or placebo. A randomization sequence will be generated by computer, which creates identification codes necessary for the correct labeling of the drug and allocation of the patients in the experimental groups (https://www.sealedenvelope.com). This code will be adopted in the Case Report Form of the patient. The designation of the experimental group will be known by the data analysts, but hidden from the participants and the team involved with the treatment and research.
Primary Purpose: Supportive Care
Official Title: CBD/THC Solution as a Pharmacological Strategy for Patients With Fibromyalgia. Single-center, Double-blind, Randomized, Placebo-controlled Clinical Trial Protocol (FibroCann)
Estimated Study Start Date : April 15, 2022
Estimated Primary Completion Date : August 20, 2022
Estimated Study Completion Date : November 20, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

Arm Intervention/treatment
Placebo Comparator: Placebo
10 participants will receive placebo (vehicle). The placebo will match the study drug in odor, taste, color and appearance. The administration will occur daily, once a day, during the night period, before going to bed and 30 minutes after the meal, during the next 120 days.
Drug: Placebo
The placebo will match the study drug in odor, taste, color and appearance to ensure proper masking.

Experimental: cannabidiol and tetrahydrocannabinol 1:1 (0.1 mg/ml)
10 participants will receive CBD and THC in the same concentration (1:1) (0.1 mg/ml). The administration will occur daily, once a day, during the night period, before going to bed and 30 minutes after the meal, during the next 120 days.
Drug: cannabidiol and tetrahydrocannabinol
CBD and THC will be given in the same concentration within a group of 10 participants, while its effects will be compared with the other two groups with 10 participants each and the placebo group.
Other Names:
  • CBD/THC
  • CBD and THC

Experimental: cannabidiol and tetrahydrocannabinol 1:1 (1.0 mg/ml)
10 participants will receive CBD and THC in the same concentration (1:1) (1.0 mg/ml). The administration will occur daily, once a day, during the night period, before going to bed and 30 minutes after the meal, during the next 120 days.
Drug: cannabidiol and tetrahydrocannabinol
CBD and THC will be given in the same concentration within a group of 10 participants, while its effects will be compared with the other two groups with 10 participants each and the placebo group.
Other Names:
  • CBD/THC
  • CBD and THC

Experimental: cannabidiol and tetrahydrocannabinol 1:1 (10.0 mg/ml)
10 participants will receive CBD and THC in the same concentration (1:1) (10.0 mg/ml). The administration will occur daily, once a day, during the night period, before going to bed and 30 minutes after the meal, during the next 120 days.
Drug: cannabidiol and tetrahydrocannabinol
CBD and THC will be given in the same concentration within a group of 10 participants, while its effects will be compared with the other two groups with 10 participants each and the placebo group.
Other Names:
  • CBD/THC
  • CBD and THC




Primary Outcome Measures :
  1. Dose-response curve and median effective dose [ Time Frame: Within 120 days ]
    The primary outcome is the dose-response curve and median effective dose (ED50) in relation to the change in pain intensity within the dose range determined in this study, compared to placebo, as measured by the McGill Questionnaire.


Secondary Outcome Measures :
  1. Pain catastrophizing [ Time Frame: Within 120 days ]
    Effectiveness in changing fibromyalgia symptoms through a change in pain catastrophizing: by the Pain Catastrophic Scale (B-PCS). A questionnaire is applied to patients aiming to indicate the degree to which they have thoughts and feelings when they are experiencing pain using the 0 (not at all), 1 (to a slight degree), 2 (to a moderate degree), 3 (to a great degree) and 4 (all the time) scale. A total score is yielded (ranging from 0-52), along with three subscale scores assessing rumination, magnification and helplessness. A total PCS score of 30 represents clinically relevant level of catastrophizing.

  2. Acceptance in relation to pain [ Time Frame: Within 120 days ]
    Change of acceptance and daily action in relation to pain: by the Acceptance and Action Questionnaire-II (AAQ-II). A questionnaire containing statements is applied to patients aiming to indicate the degree to which they have thoughts and feelings when they are experiencing pain using the 1 (never true), 2 (very seldom true), 3 (seldom true), 4 (sometimes true), 5 (frequently true), 6 (almost always true), 7 (always true). The association of the score values with the acceptance to pain will vary with the statements in the questionnaire.

  3. Depressive symptoms [ Time Frame: Within 120 days ]
    Change in depressive symptoms: data from the Beck Depression Inventory and the Hamilton Depression Rating Scale (HAM-D). In both tests, higher scores are related to higher levels of depession. Generally, in the Beck Depression Inventory, scores 1-10 are considered normal; 11-16 are considered to be Mild mood disturbance; 17-20 are considered to be Borderline clinical depression; 21-30 are considered to be Moderate depression; 31-40 are considered to be Severe depression and values over 40 are considered as Extreme depression. In theHAM-D Scores: A pacient score around 0-7 is considered as Normal; 8-13 is considered as Mild; 14-18 is considered as Moderate; 19-22 is considered as Severe; ≥23 is considered as Very severe.

  4. Sleep quality [ Time Frame: Within 120 days ]
    Change in sleep quality: Subjective domain of sleep quality using the Pittsburgh Sleep Quality Index (PSQI). In the Pittsburgh Sleep Quality Index, nineteen individual items are used to generate seven considerations: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The scores for these seven components are summed to yield a total score ranging from 0 to 21, with the global score indicating worse sleep quality.

  5. Insomnia Severity [ Time Frame: Within 120 days ]
    By the Insomnia Severity Index; Change in quality of life: using the Fibromyalgia Impact Questionnaire (FIQ). The Insomnia Severity Index has seven questions. The scores for these seven components are summed to yield a total score. Results ranging from 0-7 mean no clinically significant insomnia; 8-14 mean subthreshold insomnia; 15-21 mean moderate severity insomnia; 22-28 mean severe insomnia. In the The Fibromyalgia Impact Questionnaire, higher score indicates a greater impact of the insomnia syndrome on the person.

  6. Daytime sleepiness [ Time Frame: Within 120 days ]
    Absence of daytime sleepiness: according to the Epworth sleepiness scale (ESS). The ESS is a self-administered questionnaire with 8 questions. The questions can be answered ranging 0 to 3, according to their usual chances of dozing off or falling asleep while engaged in eight different activities. The ESS score is the sum of the values of the 8 questions and can range from 0 to 24. The higher the ESS score, the higher that person's average sleep propensity in daily life (ASP), or their 'daytime sleepiness'. Generally scores ranging 0-5 mean Lower Normal Daytime Sleepiness; 6-10 mean Higher Normal Daytime Sleepiness; 11-12 mean Mild Excessive Daytime Sleepiness; 13-15 mean Moderate Excessive Daytime Sleepiness; 16-24 mean Severe Excessive Daytime Sleepiness.

  7. Sleep duration [ Time Frame: Within 120 days ]
    Change in sleep duration: PSQI, sleep duration domain



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Previous diagnosis of fibromyalgia based on the pharmacological criteria of the American College of Rheumatology, 2016 to fibromyalgia, having received three months of pharmacological treatment without relevant clinical improvement;
  • Adult individuals (aged 18 to 75 years) with a mean pain intensity greater than or equal to 7 on the FIQ numerical pain scale (Fibromyalgia Impact Questionnaire);
  • No use of Cannabis or its derivatives (THC and CBD) in any systemic administration route in the last six months;
  • Capability to read, write and speak in Portuguese (Brazil);
  • Sign the ICF (Informed Consent Form).

Exclusion Criteria:

  • Pregnancy or breastfeeding;
  • Any known pathology, in an advanced stage, associated with the locomotor system (arthritis, osteoarthritis, uric acid);
  • Neurological disorders;
  • Previously reported renal disorders or changes in the exams during the pre-randomization stage;
  • Previously reported liver disorders or changes in tests during the pre-randomization stage;
  • Peripheral neuropathy;
  • Known serious cardiovascular disease (uncontrolled hypertension, heart failure, cardiac pacemaker);
  • Medical decision that participation in the study is not in the best interest of the patient;
  • Making previous use of cannabinoids by any route of administration;
  • Diagnosis of alcohol dependence;
  • Usage of psychotomimetic drugs or narcotics;
  • Having participated in research projects in the two months prior to the beginning of the study;
  • Having a history or having first-degree relatives with a history of psychosis in any level at least once in their lifetime;
  • Inappropriate metabolic profile of THC or CBD cannabinoids for the use of the test doses in this study, observed by pharmacogenetic testing.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05283161


Contacts
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Contact: Fernando C Dos Santos, PhD +55 (45) 3031-2262 contato@3fclinicaltrials.com
Contact: Rodrigo C Simoes +55 (45) 3031-2262 contato@3fclinicaltrials.com

Sponsors and Collaborators
FG Brasil LTDA
3F Clinical Trials LTDA
Investigators
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Principal Investigator: Osvaldo Antonio H Junior 3F Clinical Trials LTDA
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Responsible Party: FG Brasil LTDA
ClinicalTrials.gov Identifier: NCT05283161    
Other Study ID Numbers: 04200240
First Posted: March 16, 2022    Key Record Dates
Last Update Posted: April 11, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by FG Brasil LTDA:
rheumatic syndrome
Muscle pain
Fibromyalgia
Additional relevant MeSH terms:
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Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Dronabinol
Cannabidiol
Anticonvulsants
Hallucinogens
Physiological Effects of Drugs
Psychotropic Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Cannabinoid Receptor Agonists
Cannabinoid Receptor Modulators
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists