Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04031313
Recruitment Status : Not yet recruiting
First Posted : July 24, 2019
Last Update Posted : August 7, 2019
Sponsor:
Collaborator:
Rambam Health Care Campus
Information provided by (Responsible Party):
Dorit Pud, University of Haifa

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.

Condition or disease
Chronic Pain

  Show Detailed Description

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: Effectiveness and Safety of Oil Extracts Medical Cannabis Treatment for Patients With Chronic Pain: a Web Technology Based Prospective Study
Estimated Study Start Date : August 2019
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. The change from baseline in the number that best describes pain intensity during the last week (0-10) [ Time Frame: six months ]
    The change from baseline in the number that best describes pain intensity during the last week (0-10)


Secondary Outcome Measures :
  1. The change from baseline in PDI [ Time Frame: six months ]
    The change from baseline in disability. PDI = Pain Disability Index. Total score 0-10

  2. The change from baseline in QOL [ Time Frame: six months ]
    The change from baseline in quality of life. EuroQol (EQ5). Total score 0-10

  3. The change from baseline in SF-MPQ [ Time Frame: six months ]
    The change from baseline in total McGill pain intensity score (SF-MPQ). Total score 0-45

  4. The change from baseline in PSQI [ Time Frame: six months ]
    The change from baseline in Sleep quality. Pittsburgh Sleep Quality Index (PSQI). Total score 0-21.

  5. The change from baseline in PCS [ Time Frame: six months ]
    The change from baseline in pain catastrophizing. Pain Catastrophizing Scale (PCS). Total score 0-52



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04031313


Contacts
Layout table for location contacts
Contact: Tamar Gershoni, BA +972523336933 tamarbr07@gmail.com

Sponsors and Collaborators
Dorit Pud
Rambam Health Care Campus
Investigators
Layout table for investigator information
Principal Investigator: Dorit Pud, PhD University of Haifa

Layout table for additonal information
Responsible Party: Dorit Pud, Full Professor, University of Haifa
ClinicalTrials.gov Identifier: NCT04031313     History of Changes
Other Study ID Numbers: UnivHaifa
First Posted: July 24, 2019    Key Record Dates
Last Update Posted: August 7, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Chronic Pain
Pain
Neurologic Manifestations
Signs and Symptoms