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Cannabinoids Effects on the Pain Modulation System

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02560545
Recruitment Status : 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

Tracking Information
First Submitted Date  ICMJE September 24, 2015
First Posted Date  ICMJE September 25, 2015
Last Update Posted Date June 14, 2018
Study Start Date  ICMJE September 2015
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 24, 2015)
evaluation of pain [ Time Frame: 1 months ]
The evaluation will be made by Questionnaire
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02560545 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 12, 2018)
  • Testing of the pain and pain-modulation system [ Time Frame: 1 months ]
    The testing will be made and analyzed by TSA Neurosensory Analyzer
  • Functional brain correlates [ Time Frame: 1 month ]
    will be examined using fMRI
Original Secondary Outcome Measures  ICMJE
 (submitted: September 24, 2015)
Testing of the pain and pain-modulation system [ Time Frame: 1 months ]
The testing will be made and analyzed by TSA Neurosensory Analyzer
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cannabinoids Effects on the Pain Modulation System
Official Title  ICMJE Cannabinoids Effects on the Pain Modulation System
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Diagnostic
Condition  ICMJE Neuropathic Pain
Intervention  ICMJE Drug: Cannabis oil
Cannabis oil 20% THC
Study Arms  ICMJE
  • Active Comparator: Cannabis oil
    Cannabis oil, 20% THC 0.2 mg/kg
    Intervention: Drug: Cannabis oil
  • Placebo Comparator: Placebo
    Oil
    Intervention: Drug: Cannabis oil
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: September 24, 2015)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2019
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 25 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02560545
Other Study ID Numbers  ICMJE TASMC-15-LD-0001-15-CTIL
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party michal roll, Tel-Aviv Sourasky Medical Center
Study Sponsor  ICMJE Tel-Aviv Sourasky Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Tel-Aviv Sourasky Medical Center
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP