Cannabinoids Effects on the Pain Modulation System

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.

Study Overview

• Status: Unknown
• Conditions: Neuropathic Pain
• Intervention / Treatment: Drug: Cannabis oil

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Tel Aviv, Israel
    • Pain Institute, Tel Aviv Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
evaluation of pain	The evaluation will be made by Questionnaire	1 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Testing of the pain and pain-modulation system	The testing will be made and analyzed by TSA Neurosensory Analyzer	1 months
Functional brain correlates	will be examined using fMRI	1 month

Collaborators and Investigators

• Sponsor: Tel-Aviv Sourasky Medical Center

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Anticipated): September 1, 2019
• Study Completion (Anticipated): September 1, 2019

Study Registration Dates

• First Submitted: September 24, 2015
• First Submitted That Met QC Criteria: September 24, 2015
• First Posted (Estimate): September 25, 2015

Study Record Updates

• Last Update Posted (Actual): June 14, 2018
• Last Update Submitted That Met QC Criteria: June 12, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Neuralgia
• Other Study ID Numbers: TASMC-15-LD-0001-15-CTIL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO