NCT03635593

Brief Summary

Cannabis is being prescribed medically for chronic non-cancer pain despite limited evidence whether or not it works to reduce average pain in patients with chronic non-cancer pain. The cannabis plant (Cannabis sativa, Cannabis indica) consists of several hundred compounds of which, approximately 70 of which are thought to be active. The two active cannabinoids of interest in this trial are tetrahydrocannabinol (Δ9-THC) and cannabidiol (CBD). The goal of this trial is to determine whether CBD or CBD+THC reduces the average pain in participants with chronic non-cancer pain. The investigators also aim to determine whether CBD or CBD+THC is associated with a reduction in pain severity, pain interference, anxiety, depression, insomnia, opioids and use of benzodiazepines, analgesics, antidepressants, anxiolytics, or hypnotics amongst chronic non-cancer pain patients or an increase in physical functioning, physical health related role limitations, social functioning, mental functioning.

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
309

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

August 15, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 17, 2018

Completed
5 months until next milestone

Study Start

First participant enrolled

January 1, 2019

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2021

Completed
Last Updated

November 13, 2018

Status Verified

November 1, 2018

Enrollment Period

2.1 years

First QC Date

August 15, 2018

Last Update Submit

November 8, 2018

Conditions

Chronic Non-cancer Pain

Outcome Measures

Primary Outcomes (1)

  • Average Pain Score

    Relative change in Average Pain Score measured by the Average Pain Score ( 0=No Pain and 10=Pain as bad as you can imagine) from the Numeric Rating Scale

    12 weeks after Treatment (Week 16 of trial)

Secondary Outcomes (12)

  • Pain Severity Score

    Baseline, week 4, 8, 12 and 16

  • Pain Intensity Score

    Baseline, week 4, 8, 12 and 16

  • Physical Functioning Score

    Baseline, week 4, 8, 12 and 16

  • Mental Health Score

    Baseline, week 4, 8, 12 and 16

  • Social Functioning Score

    Baseline, week 4, 8, 12 and 16

  • +7 more secondary outcomes

Study Arms (3)

CBD

ACTIVE COMPARATOR

10mg capsules Cannabidiol (CBD)

Drug: CBD

CBD+THC

ACTIVE COMPARATOR

10mg capsules Cannabidiol (CBD) +THC tetrahydrocannabinol (CBD 5mg + (THC)

Drug: CBD+THC

Placebo

PLACEBO COMPARATOR

10mg capsules placebo

Other: Placebo

Interventions

CBDDRUG

Participants will be randomized to CBD 10mg capsules for 12 weeks. Participants will start with 1, CBD (10mg) capsule per day and self-titrate up to 8, 10mg CBD capsules (80mg) per day as needed.

CBD
CBD+THCDRUG

Participants will be randomized to CBD+THC 10mg (CBD 5mg + THC) for 12 weeks. Participants will start with 1, 10mg CBD+THC (5mg+5mg) capsule per day and self- titrate up to 8, 10mg CBD+THC (5mg+5mg) capsules to a maximum of 80mg (40mg CBD + 40mg THC) per day as needed.

CBD+THC
PlaceboOTHER

Participants randomized to placebo 10mg capsules for 12 weeks. Participants will start with 1, 10mg placebo capsule per day and self-titrate up to 8 10mg placebo capsules (80mg) per day.

Placebo

Eligibility Criteria

Age26 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \>25
  • Average pain score in past week of ≥ 4/10.

You may not qualify if:

  • Personal history of bipolar disorder
  • Personal or family history (first degree relative - parent of sibling) of psychotic disorders (e.g., schizophrenia)
  • Active cancer (an individual undergoing active cancer chemotherapy, radiation or surgical treatment and is deemed to not be in remission as per an oncologist's report)
  • Intention to travel internationally during the trial
  • Uncontrolled diabetes (A1C \> 11)
  • Cannabis use in the past 4 weeks (recreational or medicinal)
  • Current use of illicit drugs (e.g., cocaine)
  • Current use of non-prescription opioids
  • Unable to read and write in English
  • Women who are currently pregnant or breast-feeding; or women of child-bearing age who plan to become pregnant during the trial period.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Michael G. DeGroote Pain Clinic

Hamilton, Ontario, L8N 3Z5, Canada

Location

Toronto Poly Clinic

Toronto, Ontario, Canada

Location

Central Study Contacts

Lisa L Patterson, BA

CONTACT

905-978-7908pattersl@hhsc.ca

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Director

Study Record Dates

First Submitted

August 15, 2018

First Posted

August 17, 2018

Study Start

January 1, 2019

Primary Completion

January 30, 2021

Study Completion

January 30, 2021

Last Updated

November 13, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations

CA(2)