Clinical trial NCT05351905: Improving Pain Disability With the Use of Oral Cannabinoids
Official title: A Single-centre, Pilot, Randomized Controlled Trial of Oral Cannabinoids for Improving Pain Disability in Patients With Chronic Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Pain
Opioid Use
Cannabis
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2022-04-28
Enrollment: 51
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized to receive either a placebo, CBD oil (medical cannabis) or CBD+THC oil (medical cannabis) in a 1:1:1 ratio.
Primary purpose: TREATMENT

Brief summary: The investigators are conducting a pilot (i.e. a small study) in order to find out the effectiveness and safety of medical cannabis in the management of chronic pain. At the end of this 3 month study, investigators will gather information on how easy it is for patients to enroll and complete the entire study. The results of this pilot study will help the study team design a larger randomized controlled trial.

Detailed description: Chronic pain is defined as pain lasting longer than three months, affects \~20% of Canadian adults. In addition to having a significant negative impact at the individual patient level (i.e., decreased quality of life and functioning), chronic pain is also a main cause of disability and health care use. Opioids are frequently prescribed to manage chronic pain despite limited data on their long term usefulness and has become one of the major contributors to the current opioid crisis in Canada. Chronic pain can potentially be treated with medical cannabis as an adjunct or alternative to opioids due to their similar behavioral, anatomical and biochemical mechanisms. Cannabinoids also potentially prevent the development of tolerance to opioids when co-administered.

Cannabinoids have demonstrated the ability to reduce pain as well as opioid-sparing effects in pre-clinical and clinical studies however further research is needed to identify the optimal make-up, ratio, and dosage of cannabinoids to minimize harms and maximize benefits. Furthermore, studies conducted to date have methodological problems such as short follow-up windows (hours or days) that limit conclusions. The investigators therefore propose a randomized, placebo-controlled trial of oral cannabinoids \[CBD (cannabidiol) alone or in combination with THC (delta-9-tetrahydrocannabinol)\] for reducing pain disability and opioid use for pain management in chronic pain. However, there are a number of feasibility issues that should be addressed prior to launching a full-scale trial in this area. Some issues have been identified in the literature (e.g., success of blinding) while others are related to the changing socio-medico-legal landscape surrounding cannabis use in Canada.

The purpose of this pilot study is to test the study plan, patient recruitment and compliance with the study procedures. Results of this study may be used as a guide for larger studies and will help us determine if medical cannabis can reduce daily opioid doses and/or decrease pain interference (disability) in chronic pain patients.

This study will aim to recruit 51 patients from the Toronto General Hospital Transitional Pain Service.

Study Procedure: After obtaining the Informed consent, patients will be randomized into one of the three study groups. Patients will either receive CBD oil, CBD+THC oil or placebo orally for 12 weeks. Starting dose will be 1 ml per day. The dose of study drug will be adjusted based on patients' reported efficacy and adverse effects. After starting the study drug, patients will have scheduled study visits either remotely or in-person at 4, 8, and 12 weeks plus a follow up calls or virtual clinic visit(OTN) at 2 and 6 weeks. At every study visit, patients will be asked to complete the questionnaires that will assess their pain level and how it affects their quality of life, opioid use, and side effects if they are experiencing. The investigators will also collect information on: demographic and baseline characteristics (e.g., sex, age, height, weight, and body mass index) and medical history (including prior and concomitant medications) via patient interview or from inspection of medical records. Additionally, symptoms of depression and anxiety will be measured with the validated screening tools at baseline and 12 weeks post-treatment.

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 25 years
2. Able to understand and read English
3. Experiencing chronic, non-palliative pain

Exclusion Criteria:

1. Use of nabilone, nabiximols or cannabis in the 30 days preceding study recruitment
2. Known allergy to cannabis or any cannabinoid
3. Serious ongoing medical issues (i.e., lung, liver, kidney or heart disease) that in the opinion of the Investigator would compromise the safety of the patient
4. Current uncontrolled serious mental disorders such as schizophrenia, or psychosis
5. Currently pregnant or breast-feeding (a negative urine pregnancy test must be obtained for women of child bearing potential during pretreatment evaluation)
6. Men and women planning to start a family in the next 12 weeks
7. Has declared a current alcohol or substance use disorder (excluding opioid use disorder)
8. Currently using Methadone or Buprenorphine
9. Patients who are naïve to pain treatments

Primary outcomes:
measure: Feasibility outcome: pertaining to the patients recruitment
timeFrame: Through study completion, an average of 1 year
measure: Feasibility outcome: pertaining to adherence to intervention
timeFrame: Up to 12 weeks post-treatment
measure: Feasibility outcome: pertaining to withdrawal from study
timeFrame: Up to 12 weeks post-treatment
measure: Feasibility outcome: pertaining to questionnaire data
timeFrame: Up to 12 weeks post-treatment
measure: Feasibility outcome: the rate of unintentional unblinding
timeFrame: Up to 12 weeks post-treatment
Secondary outcomes:
measure: The mean Morphine Equivalent (MEQ) dose (mg/day) at 12 weeks post-treatment for patients that were consuming opioids at the start of the trial
timeFrame: Baseline and at 2-,4-,6-,8- and 12-weeks post-treatment
measure: The mean pain interference at 12 weeks post-treatment
timeFrame: Baseline and at 2-,4-,6-,8- and 12-weeks post-treatment
Other outcomes:
measure: The proportion of patients weaned off opioids at 12 weeks post-treatment initiation for patients that were consuming opioids at the start of the trial
timeFrame: 12-weeks post-treatment
measure: Mean pain severity scores at 12-weeks post-treatment
timeFrame: Baseline and at 2-,4-,6-,8- and 12-weeks post-treatment
measure: Overall improvement related to the intervention
timeFrame: Baseline and at 2-,4-,6-,8- and 12-weeks post-treatment
measure: Adverse events assessment
timeFrame: Baseline and at 2-,4-,6-,8- and 12-weeks post-treatment
measure: Assessment of symptoms of anxiety
timeFrame: Baseline and at 12-weeks post-treatment
measure: Assessment of symptoms of depression
timeFrame: Baseline and at 12-weeks post-treatment
Locations:
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
Study officials:
affiliation: Toronto General Hospital, UHN
name: Hance Clarke, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: