Efficacy Trial of Oral Tetrahydrocannabinol in Patients With Fibromyalgia

NCT ID: NCT01149018

Last Updated: 2010-06-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2012-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The objective of the study is to evaluate the effectiveness of oral tetrahydrocannabinol in patients suffering from Fibromyalgia

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Fibromyalgia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Tetrahydrocannabinol

Group Type EXPERIMENTAL

Tetrahydrocannabinol

Intervention Type DRUG

Oral solution of THC in concentration of 5mg/0.2ml. Dose regimen: 5mg 2-4 times/day as tolerated.

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Orally administered olive oil. Dose: 0.2ml 2-4 times a day as tolerated

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Tetrahydrocannabinol

Oral solution of THC in concentration of 5mg/0.2ml. Dose regimen: 5mg 2-4 times/day as tolerated.

Intervention Type DRUG

Placebo

Orally administered olive oil. Dose: 0.2ml 2-4 times a day as tolerated

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

\- Adult (\>18y.o) Patient with Fibromyalgia, diagnosed by ACR criteria

Exclusion Criteria

\- Children \< 18 years old

Patients with following psychiatric disorders:

* Psychosis or history of acute psychosis
* Schizophrenia
* Bipolar disorder Patients smoking marijuana, using hashish or any other form of cannabis. Patients with history of drug abuse or illicit drug use Patients receiving chronic treatment with strong opioids (Morphine, Oxycodone, Fentanyl, Methadone, Hydromorphone, Buprenorphine, Pethidine). Weak opioids as Tramadol or Propoxyphene will be allowed.

Pregnant patients
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hebrew University of Jerusalem

OTHER

Sponsor Role collaborator

Hadassah Medical Organization

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Hadassah Medical Organization

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Pain Relief Unit, Hadassah Medical Organisation

Jerusalem, , Israel

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Israel

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Elyad Davidson, MD

Role: CONTACT

+972 2677 6911

Simon Haroutiunian, M.Sc

Role: CONTACT

+972 2677 6770

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

THC-FMS-HMO-CTIL

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Use of Cannabis Oil in Fibromyalgia
NCT07194018 ACTIVE_NOT_RECRUITING
Psilocybin-facilitated Treatment for Chronic Pain
NCT05068791 RECRUITING EARLY_PHASE1
Neurotropin Treatment of Fibromyalgia
NCT00366535 COMPLETED PHASE2
Psilocybin Therapy for Chronic Low Back Pain
NCT05351541 RECRUITING PHASE1/PHASE2