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

NCT05283161 | Unknown Phase 2 DMC

• 1 other identifier: 04200240
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Fibromyalgia

Keywords

rheumatic syndrome; Muscle pain; Fibromyalgia

Outcome Measures

Primary Outcomes (1)

• Dose-response curve and median effective dose

  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.

  Within 120 days

Secondary Outcomes (7)

• Pain catastrophizing

  Within 120 days

• Acceptance in relation to pain

  Within 120 days

• Depressive symptoms

  Within 120 days

• Sleep quality

  Within 120 days

• Insomnia Severity

  Within 120 days

Study Arms (4)

Placebo

PLACEBO COMPARATOR

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

cannabidiol and tetrahydrocannabinol 1:1 (0.1 mg/ml)

EXPERIMENTAL

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

cannabidiol and tetrahydrocannabinol 1:1 (1.0 mg/ml)

EXPERIMENTAL

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

cannabidiol and tetrahydrocannabinol 1:1 (10.0 mg/ml)

EXPERIMENTAL

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

Interventions

cannabidiol and tetrahydrocannabinol DRUG

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.

Also known as: CBD/THC, CBD and THC

cannabidiol and tetrahydrocannabinol 1:1 (0.1 mg/ml); cannabidiol and tetrahydrocannabinol 1:1 (1.0 mg/ml); cannabidiol and tetrahydrocannabinol 1:1 (10.0 mg/ml)

Placebo DRUG

The placebo will match the study drug in odor, taste, color and appearance to ensure proper masking.

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• FG Brasil LTDA: lead
• 3F Clinical Trials LTDA: collaborator

MeSH Terms

Conditions

Fibromyalgia; Myalgia

Interventions

Cannabidiol; Dronabinol

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Musculoskeletal Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Study Officials

• Osvaldo Antonio H Junior

  3F Clinical Trials LTDA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fernando C Dos Santos, PhD

CONTACT

+55 (45) 3031-2262; contato@3fclinicaltrials.com

Rodrigo C Simoes

CONTACT

+55 (45) 3031-2262; contato@3fclinicaltrials.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 8, 2022
• First Posted: March 16, 2022
• Study Start: April 15, 2022
• Primary Completion: August 20, 2022
• Study Completion: November 20, 2022
• Last Updated: April 11, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share