NCT02388217

Brief Summary

The objective of the current study is to prospectively assess the effect of cannabis on pain and functional outcomes in a large group of patients with chronic pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

April 1, 2013

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

April 6, 2014

Completed
11 months until next milestone

First Posted

Study publicly available on registry

March 13, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
3.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2020

Completed
Last Updated

March 22, 2022

Status Verified

March 1, 2022

Enrollment Period

3.9 years

First QC Date

April 6, 2014

Last Update Submit

March 20, 2022

Conditions

Chronic Pain

Keywords

chronic paincannabisApproved for cannabis treatment by Israeli ministry of healthUnrelieved chronic pain

Outcome Measures

Primary Outcomes (1)

  • Change from baseline on the S-TOPS pain symptom scale

    The primary outcome is pain reduction (change from baseline) assessed by the Pain Symptom scale of the S-TOPS instrument

    1 year

Secondary Outcomes (5)

  • Change from baseline on S-TOPS physical disability scales

    6 and 12 months

  • Change from baseline on S-TOPS emotional/social disability scales

    6 and 12 months

  • Change from baseline on S-TOPS satisfaction scales

    6 and 12 months

  • Change from baseline on SLP9 sleep disability scale

    6 and 12 months

  • Change from baseline on BPI severity/interference scales

    6 and 12 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Chronic pain patients with lack of satisfactory analgesic response or intolerable adverse effects with at least two analgesics from 2 different drug classes at full dose. Eligible for cannabis treatment following Israeli Ministry of Health approval.

You may qualify if:

  • Age \>18 years old
  • Chronic pain, with duration of 3 months or longer
  • Lack of satisfactory analgesic response or intolerable adverse effects with at least two analgesics from 2 different drug classes at full dose.

You may not qualify if:

  • Inability to read and understand the informed consent form.
  • History of drug abuse/dependence
  • Psychiatric co morbidity (or history) of schizophrenia or acute psychosis.
  • Family history of schizophrenia.
  • Psychologist evaluation of high abuse risk.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah Medical Center

Jerusalem, Israel

Location

MeSH Terms

Conditions

Chronic PainMarijuana Abuse

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

April 6, 2014

First Posted

March 13, 2015

Study Start

April 1, 2013

Primary Completion

March 1, 2017

Study Completion

November 1, 2020

Last Updated

March 22, 2022

Record last verified: 2022-03

Locations

IL(1)