Cannabinoids Effects on the Pain Modulation System

• ClinicalTrials.gov Identifier: NCT02560545
• Recruitment Status: Unknown
• First Posted: September 25, 2015
• Last Update Posted: June 14, 2018
• Sponsor: Tel-Aviv Sourasky Medical Center
• Information provided by (Responsible Party): michal roll, Tel-Aviv Sourasky Medical Center

Tracking Information

• First Submitted Date: September 24, 2015
• First Posted Date: September 25, 2015
• Last Update Posted Date: June 14, 2018
• Study Start Date: September 2015
• Estimated Primary Completion Date: September 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 24, 2015)

evaluation of pain [ Time Frame: 1 months ]

The evaluation will be made by Questionnaire

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (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 (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: Cannabinoids Effects on the Pain Modulation System
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Diagnostic
• Condition: Neuropathic Pain

Intervention

Drug: Cannabis oil

Cannabis oil 20% THC

Study Arms

• 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

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: September 24, 2015): 40
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: September 2019
• Estimated Primary Completion Date: September 2019 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 25 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Israel

Administrative Information

• NCT Number: NCT02560545
• Other Study ID Numbers: TASMC-15-LD-0001-15-CTIL
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: michal roll, Tel-Aviv Sourasky Medical Center
• Original Responsible Party: Same as current
• Current Study Sponsor: Tel-Aviv Sourasky Medical Center
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Tel-Aviv Sourasky Medical Center
• Verification Date: June 2018