The Impact of THC on Pain Modulation in Fibromyalgia

NCT05644054 | Recruiting DMC

• 1 other identifier: TLV-16-320
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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. 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. 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. 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. 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.

Conditions

Fibromyalgia, Primary

Outcome Measures

Primary Outcomes (3)

• Functional Connectivity (FC)

  The variations in FC measured during the resting-state scan will be assessed using within-between network connectivity at baseline and following treatments with either THC or a placebo in FMS patients.

  2 hours after drug administration

• Blood Oxygenation Level (BOLD)

  The variations in BOLD activity measured during the sensory test will be assessed using ROI to ROI analysis at baseline and following treatments with either THC or a placebo in FMS patients.

  2 hours after drug administration

• Quantitative Sensory Tests: Conditioned pain modulation (CPM) and offset analgesia (OA) magnitude

  Baseline assessments of CPM and OA magnitude will be conducted for both FMS patients and their corresponding healthy control group. Furthermore, the magnitude of these tests will also be evaluated after administering either THC or placebo treatments in FMS patients.

  2 hours after drug administration

Study Arms (2)

Treatment (THC) - session 1

EXPERIMENTAL

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

Drug: THC

Placebo - session 2

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

THC 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)

Treatment (THC) - session 1

Placebo DRUG

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

Placebo - session 2

Eligibility Criteria

• Age: 20 Years - 60 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnosed with fibromyalgia for over 3 months according to American college of rheumatology
• Do not respond well to analgesic medications and or have severe side effects
• Medium to high level of pain (over 40 on visual analogue scale scale)
• Does not have other pain-related syndromes
• Not treated regularly with cannabis.
• Is ready to stop taking central nervous system medications 3 days prior to the experiment.

You may not qualify if:

• alleviated levels of anxiety (above 52 in STAI)
• Psychiatric medications due to psychiatric diagnoses (depression, bi-polar syndrome, etc.).
• Cardiovascular problems
• Neurological diseases (other than migraine).
• Pregnancy or breastfeeding
• Alcoholism or substance abuse
• Cancer
• Blood pressure problems
• Patients that used cannabis in the past month
• Illegibility to MRI

Sponsors & Collaborators

• Tel Aviv Medical Center: lead

Study Sites (1)

Tel Aviv Medical Center

Tel Aviv, 6997712, Israel

RECRUITING

MeSH Terms

Conditions

Fibromyalgia

Interventions

Dronabinol

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Study Officials

• Jacob Ablin, MD

  Tel-Aviv Sourasky Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yara Agbaria

CONTACT

972522839351; yaraa@tlvmc.gov.il

Jacob Ablin, MD

CONTACT

972524266774; jacobab@tlvmc.gov.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Neither the participants nor the investigators will be aware of the drug being administered.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: researcher

Model Details: A Cross-Over, Double-Blind Placebo-Controlled Study

Study Record Dates

• First Submitted: November 21, 2022
• First Posted: December 9, 2022
• Study Start: January 1, 2023
• Primary Completion: April 1, 2024
• Study Completion: December 1, 2024
• Last Updated: March 26, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)