Effectiveness and Safety of Oil Extracts Medical Cannabis Treatment for Patients With Chronic Pain

NCT04031313 | Unknown

• 1 other identifier: UnivHaifa
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

Background: The current study will prospectively follow-up on chronic pain patients treated with oil extracts of medical cannabis (MC) for a period of six months in "real life" conditions. This study will enable a deep investigation regarding the effects of the active extract of cannabis inflorescence formulated in oil, derived from the cannabis plant. The results may allow us to reduce the gap in understanding MC's effects on pain relief and its safety, to identify predictors for treatment success/ failure, as well as to enable us tailoring a personalize MC treatment by choosing optimal concentration and dose according to the patient needs. We hypothesize that following the treatment with oil extracts of MC for chronic pain, associations will be found between its effectiveness and the types of clinical pain, personality traits and demographic characteristics. We also do not expect serious (life threatening) adverse events to be reported. Methods: This study has been already approved by the ethics committee of Haifa University (approval number 216/19). The sample will include a prospective cohort of 600 patients with chronic non-cancer pain that will request license to use oil extracts MC. The patients who will be approved to receive a license will be followed-up longitudinally for a period of six months from the signing of the consent form. The patients will be asked to fill a variety of questionnaires that may indicate the outcome of the treatment. The follow-up will take place in four time points: at the time of approval of the license (before starting the treatment, baseline), as well as at one, three, and six months from the initiation of treatment. Data will be collected by a web based data collection technology (Qualtrics®). In cases which there are a need for it, the information will be gathered by phone or face to face meetings.

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (1)

• The change from baseline in the number that best describes pain intensity during the last week (0-10)

  The change from baseline in the number that best describes pain intensity during the last week (0-10)

  six months

Secondary Outcomes (5)

• The change from baseline in PDI

  six months

• The change from baseline in QOL

  six months

• The change from baseline in SF-MPQ

  six months

• The change from baseline in PSQI

  six months

• The change from baseline in PCS

  six months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The sample will include a prospective cohort of patients with chronic non-cancer pain that will request license to use oil extracts medical cannabis. The estimated sample size is 600 patients. The patients who will be approved to receive a license will be followed-up longitudinally for a period of six months from the signing of the consent form. The patients will be recruited by their physicians in their clinics.

You may qualify if:

• Patients that will be recommended to use oil extracts medical cannabis for the treatment of all forms of chronic pain (despite cancer)
• Patients above the age of 18 years
• Patients who will sign an informed consent after receiving explanation on the requirements, duration and nature of the study
• Only patients who will receive at least one dose of cannabis within the context of the study, will be included in the analysis.

You may not qualify if:

• Patients who lack the ability to understand the purpose and instructions of the study.

Sponsors & Collaborators

• Dorit Pud: lead
• Rambam Health Care Campus: collaborator
• Sheba Medical Center: collaborator

Study Sites (1)

Rambam Health Care Campus

Haifa, Israel

RECRUITING

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Dorit Pud, PhD

  University of Haifa

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tamar Gershoni, BA

CONTACT

+972523336933; tamarbr07@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: July 20, 2019
• First Posted: July 24, 2019
• Study Start: August 1, 2019
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2021
• Last Updated: September 10, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)