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Cannabinoids Effects on the Pain Modulation System

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ClinicalTrials.gov Identifier: NCT02560545
Recruitment Status : Unknown
Verified June 2018 by michal roll, Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Active, not recruiting
First Posted : September 25, 2015
Last Update Posted : June 14, 2018
Sponsor:
Information provided by (Responsible Party):
michal roll, Tel-Aviv Sourasky Medical Center

Study Description
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Brief Summary:

Effective treatment of acute pain, chronic and persistent is the most important concern in the world today. Although a variety of pain medications including anti-inflammatory painkillers and opiouids, patients continue to suffer from pain constantly. For over a century ,International committees studied the issue of cannabis, and almost uniformly recommended the use of cannabis for various medical applications ,especially those that include pain treatment.

Despite the widespread use of THC in clinical practice, there are few studies on the efficacy of THC In a double-blind, randomized trial. In addition, few studies examined the effect of THC on the experience pain in healthy subjects and most of them did not find an effect on pain experimental induced by capsain. so checking other models of pain such as thermal pain and mechanical pain in addition to checking the influence on the regulation of pain will contribute to understanding the mechanism of action of THC. Understanding the mechanism of action of THC in relieving pain will lead to predicting who will benefit from this treatment and direct patients for selection of appropriate medication according to the damaged mechanism.


Condition or disease Intervention/treatment Phase
Neuropathic Pain Drug: Cannabis oil Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Diagnostic
Official Title: Cannabinoids Effects on the Pain Modulation System
Study Start Date : September 2015
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Cannabis oil
Cannabis oil, 20% THC 0.2 mg/kg
 Drug: Cannabis oil
Cannabis oil 20% THC
Placebo Comparator: Placebo
Oil
 Drug: Cannabis oil
Cannabis oil 20% THC


Outcome Measures
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Primary Outcome Measures :
  1. evaluation of pain [ Time Frame: 1 months ]
    The evaluation will be made by Questionnaire


Secondary Outcome Measures :
  1. Testing of the pain and pain-modulation system [ Time Frame: 1 months ]
    The testing will be made and analyzed by TSA Neurosensory Analyzer

  2. Functional brain correlates [ Time Frame: 1 month ]
    will be examined using fMRI


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

A. Men aged 25-65. B. Were not treated with formulation contains Cannabis C. Can sign an informed consent form. D. Patients have a medical history that supports severe neuropathic pain over Three months And do not respond to other painkillers or suffer from side effects resulting from the use them E. At least moderate pain (more than 40 on a scale of 0-100 visual analogue scale). F. Did not receive epidural injection or invasive treatment in The last month before the entry to study . G. Not drinking alcohol or consuming high concentrations of opioid and Benzodiazifinim over 24 Hours before the experiment (equivalent to 40 mg morphine).

Exclusion Criteria:

A. Patients that found with serious level of anxiety in Patient Health Questionnaire (PHQ-9) . (These patients will be recommended by a doctor appointment with a psychiatrist). B.Patients with psychiatric problems or a family history of psychiatric disorders.

C.Patients with known cardiovascular problems D.Patients with neurological problems from a central source E.Patients taking blood pressure medication F.Patients who are unable to understand and follow the instruction of the study.

G.Diffuse pain syndromes from uncertain origin (like fibromyalgia) H.Alcoholism or chronic use of drugs. I.Malignant

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02560545


Locations
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Israel
Pain Institute, Tel Aviv Medical Center
Tel Aviv, Israel
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
More Information
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Responsible Party: michal roll, Head of R&D department, Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT02560545    
Other Study ID Numbers: TASMC-15-LD-0001-15-CTIL
First Posted: September 25, 2015    Key Record Dates
Last Update Posted: June 14, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Neuralgia
Peripheral Nervous System Diseases
Neuromuscular Diseases
 Nervous System Diseases
Pain
Neurologic Manifestations