Fibromyalgia, PrimaryNCT05644054
The Impact of THC on Pain Modulation in Fibromyalgia
A study testing THC in people with Fibromyalgia, Primary, run by Tel Aviv Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 years, women only
- Conditions the study is for
- Fibromyalgia, Primary
- What is being tested?
- THC
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Jan 2023to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- Cancer
- Blood pressure problems
- Patients that used cannabis in the past month
- Illegibility to MRI
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Tel Aviv Medical Center
Tel Aviv, 6997712
Yara Agbaria, 972522839351, yaraa@tlvmc.gov.il
About this study
Official title: The Impact of THC on Pain Modulation in Fibromyalgia: A Cross-Over, Randomized, Double-Blind Placebo-Controlled Study
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:
- 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.
- 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.
- 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.
- 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.
Read the 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
- Being tested
- THC, Placebo
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
THCDrug
Patients will be administered a one-time dosage of 0.2 mg/kg THC oil (AXIBAN, T10/C2, manufactured by Panaxia Pharmaceuticals, Lod, Israel)
PlaceboDrug
Patients will be administered a one-time dosage of 0.2 mg/kg of a placebo consisting of an inactive oil.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 2 hours after drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2022
- Study start1 Jan 2023
- Primary completionApr 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fibromyalgia, PrimaryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- A Cross-Over, Double-Blind Placebo-Controlled Study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel Aviv Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, yara agbaria, Tel Aviv Medical Center
- Investigators
- Jacob Ablin, MD, Principal investigator, Tel-Aviv Sourasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05644054
- Sponsor's protocol ID
- TLV-16-320
- Status last verified
- Mar 2024
- First submitted
- 21 Nov 2022
- Last updated
- 26 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Agbaria Y, Preger R, Aloush V, Ablin JN, Sharon H, Jacob G. The impact of tetrahydrocannabinol on central pain modulation in chronic pain: a randomized clinical comparative study of offset analgesia and conditioned pain modulation in fibromyalgia. J Cannabis Res. 2025 Nov 6;7(1):86. doi: 10.1186/s42238-025-00348-x.
PubMed 41199355
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of THC on Pain Modulation in Fibromyalgia: A Cross-Over, Randomized, Double-Blind Placebo-Controlled Study
- ClinicalTrials.gov ID
- NCT05644054
- Acronym / sponsor ID
- TLV-16-320
- Conditions
- Fibromyalgia, Primary
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Tel Aviv Medical CenterUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 9 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- A Cross-Over, Double-Blind Placebo-Controlled Study
| Arm | Type | Receives |
|---|---|---|
| Treatment (THC) - session 1 | Experimental | Drug: THCPatients will attend two sessions in a crossover design, where they will receive one of the drugs in a randomized sequence at each session. |
| Placebo - session 2 | Placebo comparator | Drug: PlaceboPatients will attend two sessions in a crossover design, where they will receive one of the drugs in a randomized sequence at each session. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| THCPatients will be administered a one-time dosage of 0.2 mg/kg THC oil (AXIBAN, T10/C2, manufactured by Panaxia Pharmaceuticals, Lod, Israel) | Drug | Treatment (THC) - session 1 |
| PlaceboPatients will be administered a one-time dosage of 0.2 mg/kg of a placebo consisting of an inactive oil. | Drug | Placebo - session 2 |
Primary outcome
Functional Connectivity (FC)
Time frame: 2 hours after drug administration
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.
Blood Oxygenation Level (BOLD)
Time frame: 2 hours after drug administration
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.
Quantitative Sensory Tests: Conditioned pain modulation (CPM) and offset analgesia (OA) magnitude
Time frame: 2 hours after drug administration
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2024.
- Derived from this study: PubMed 41199355Agbaria Y, Preger R, Aloush V, Ablin JN, Sharon H, Jacob G. The impact of tetrahydrocannabinol on central pain modulation in chronic pain: a randomized clinical comparative study of offset analgesia and conditioned pain modulation in fibromyalgia. J Cannabis Res. 2025 Nov 6;7(1):86. doi: 10.1186/s42238-025-00348-x.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacob Ablin, MD principal investigator
Tel-Aviv Sourasky Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing THC in people with Fibromyalgia, Primary, run by Tel Aviv Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yara Agbaria (972522839351, yaraa@tlvmc.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Connectivity (FC) (time frame: 2 hours after drug administration). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05644054, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2024.