The Impact of THC on Pain Modulation in Fibromyalgia

NCT ID: NCT05644054

Last Updated: 2024-03-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2024-12-31

Brief Summary

The objective of this cross-sectional, double-blind, placebo-controlled clinical trial is to enhance our understanding of the pain modulation mechanisms in females diagnosed with Fibromyalgia syndrome (FMS).

This study is designed to address several key questions:

1. Is there a discernible difference in the effectiveness of the two prevalent pain modulation approaches, namely Conditioned Pain Modulation (CPM) and Offset Analgesia (OA), in individuals with FMS? To answer this, both FMS patients and an age- and sex-matched healthy control group will engage in these paradigms outside of the MRI scanner.

2. How does Tetrahydrocannabinol (THC) influence CPM and OA in FMS patients? Here, the study will observe the performance of FMS patients in both paradigms after receiving treatments with THC and a placebo, conducted outside the scanner.

3. What neural alterations in pain modulation circuits are triggered by THC? To investigate this, FMS patients will undergo the OA test inside the MRI scanner following both THC and placebo treatments.

4. How does THC affect resting-state brain function in FMS patients? This part of the study involves resting-state brain scans to measure changes in functional connectivity following treatments with THC and a placebo.

Detailed Description

Fibromyalgia syndrome (FMS) is a condition marked by pervasive chronic pain throughout the musculoskeletal system, often accompanied by chronic sleep disturbances, fatigue, memory challenges, and more. Despite significant advancements in the understanding of pain mechanisms due to breakthroughs in neuroscience and pain medicine, current treatments for FMS fall short of providing adequate relief, leaving many patients battling ongoing pain and related symptoms.

The complete pathophysiology of FMS remains elusive, but there is substantial evidence indicating the involvement of various factors, including central sensitization and impaired descending pain modulation pathways as evidenced by functional imaging studies and sensory tests such as conditioned pain modulation (CPM) and offset analgesia (OA). Given this, comprehending the pathophysiology of FMS and the mechanisms involved is crucial. Additionally, it is critical to understand how new treatments can influence pain modulation in FMS.

Recent research increasingly supports the use of cannabis, particularly Tetrahydrocannabinol (THC), for alleviating chronic pain in various syndromes. Yet, there's a lack of extensive research exploring its effectiveness in randomized, double-blind trials. Exploring THC's effects in clinical pain models could enhance our understanding of pain regulation in FMS.

The current study aims to deepen our understanding of sensory and neural mechanisms in FMS, employing quantitative sensory testing such as CPM and OA, and fMRI. A key objective is to ascertain the impact of THC on pain modulation in FMS within a double-blind controlled framework.

Conditions

Fibromyalgia, Primary

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Treatment (THC) - session 1

Patients will attend two sessions in a crossover design, where they will receive one of the drugs in a randomized sequence at each session.

Group Type: EXPERIMENTAL

THC

Intervention Type: DRUG

Patients will be administered a one-time dosage of 0.2 mg/kg THC oil (AXIBAN, T10/C2, manufactured by Panaxia Pharmaceuticals, Lod, Israel)

Placebo - session 2

Patients will attend two sessions in a crossover design, where they will receive one of the drugs in a randomized sequence at each session.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Patients will be administered a one-time dosage of 0.2 mg/kg of a placebo consisting of an inactive oil.

Interventions

THC

Patients will be administered a one-time dosage of 0.2 mg/kg THC oil (AXIBAN, T10/C2, manufactured by Panaxia Pharmaceuticals, Lod, Israel)

Intervention Type: DRUG

Placebo

Patients will be administered a one-time dosage of 0.2 mg/kg of a placebo consisting of an inactive oil.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Diagnosed with fibromyalgia for over 3 months according to American college of rheumatology

2. Do not respond well to analgesic medications and or have severe side effects

3. Medium to high level of pain (over 40 on visual analogue scale scale)

4. Does not have other pain-related syndromes

5. Not treated regularly with cannabis.

6. Is ready to stop taking central nervous system medications 3 days prior to the experiment.

Exclusion Criteria

1. alleviated levels of anxiety (above 52 in STAI)

2. Psychiatric medications due to psychiatric diagnoses (depression, bi-polar syndrome, etc.).

3. Cardiovascular problems

4. Neurological diseases (other than migraine).

5. Pregnancy or breastfeeding

6. Alcoholism or substance abuse

7. Cancer

8. Blood pressure problems

9. Patients that used cannabis in the past month

10. Illegibility to MRI

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Tel Aviv Medical Center

OTHER

Sponsor Role: lead

Responsible Party

yara agbaria

researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jacob Ablin, MD

Role: PRINCIPAL_INVESTIGATOR

Tel-Aviv Sourasky Medical Center

Locations

Tel Aviv Medical Center

Tel Aviv, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Yara Agbaria

Role: CONTACT

yaraa@tlvmc.gov.il

972522839351

Jacob Ablin, MD

Role: CONTACT

jacobab@tlvmc.gov.il

972524266774

Facility Contacts

Yara Agbaria

Role: primary

yaraa@tlvmc.gov.il

972522839351

Other Identifiers

TLV-16-320

Identifier Type: -

Identifier Source: org_study_id