NCT02560545

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

September 24, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 25, 2015

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

June 14, 2018

Status Verified

June 1, 2018

Enrollment Period

4 years

First QC Date

September 24, 2015

Last Update Submit

June 12, 2018

Conditions

Neuropathic Pain

Outcome Measures

Primary Outcomes (1)

  • evaluation of pain

    The evaluation will be made by Questionnaire

    1 months

Secondary Outcomes (2)

  • Testing of the pain and pain-modulation system

    1 months

  • Functional brain correlates

    1 month

Study Arms (2)

Cannabis oil

ACTIVE COMPARATOR

Cannabis oil, 20% THC 0.2 mg/kg

Drug: Cannabis oil

Placebo

PLACEBO COMPARATOR

Oil

Drug: Cannabis oil

Interventions

Cannabis oilDRUG

Cannabis oil 20% THC

Cannabis oilPlacebo

Eligibility Criteria

Age25 Years - 65 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pain Institute, Tel Aviv Medical Center

Tel Aviv, Israel

Location

Related Publications (1)

  • Weizman L, Sharon H, Dayan L, Espaniol J, Brill S, Nahman-Averbuch H, Hendler T, Jacob G. Oral Delta-9-Tetrahydrocannabinol (THC) Increases Parasympathetic Activity and Supraspinal Conditioned Pain Modulation in Chronic Neuropathic Pain Male Patients: A Crossover, Double-Blind, Placebo-Controlled Trial. CNS Drugs. 2024 May;38(5):375-385. doi: 10.1007/s40263-024-01085-0. Epub 2024 Apr 10.

    PMID: 38597988DERIVED

MeSH Terms

Conditions

Neuralgia

Interventions

nabiximols

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of R&D department

Study Record Dates

First Submitted

September 24, 2015

First Posted

September 25, 2015

Study Start

September 1, 2015

Primary Completion

September 1, 2019

Study Completion

September 1, 2019

Last Updated

June 14, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)