Cannabis Oil for Chronic Non-Cancer Pain Treatment

Chronic Non-cancer Pain Clinical Trial

— CONCEPT  

Official title:

Cannabis Oil for Chronic Non-CancEr Pain Treatment [CONCEPT] - Alpha (α): A Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03635593
• Other study ID #: MGD-011-20180805
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: January 1, 2019
• Est. completion date: January 30, 2021

Study information

• Verified date: November 2018
• Source: Hamilton Health Sciences Corporation
• Contact: Lisa L Patterson, BA
• Phone: 905-978-7908
• Email: pattersl[@]hhsc.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 309
• Est. completion date: January 30, 2021
• Est. primary completion date: January 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 26 Years and older

Eligibility

Inclusion Criteria:

• Age >25

• Average pain score in past week of = 4/10.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Chronic Non-cancer Pain

Intervention

Drug:
• CBD
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+THC
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.

Other:
• Placebo
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.

Locations

Country	Name	City	State
Canada	Michael G. DeGroote Pain Clinic	Hamilton	Ontario
Canada	Toronto Poly Clinic	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Hamilton Health Sciences Corporation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pain Severity Score	Decrease in Pain Severity Score measured by composite of 4 pain items (worst, least, average, now with 0=No Pain and 10=Pain as bad as you can imagine) (mean severity score) from the Brief Pain Inventory	Baseline, week 4, 8, 12 and 16
Secondary	Pain Intensity Score	Improved Pain Intensity Score measured by mean of 7 severity items (general, activity, walking, work, mood, enjoyment of life, relations with others and sleep with 0=No Pain and 10=Pain as bad as you can imagine) from the Brief Pain Inventory	Baseline, week 4, 8, 12 and 16
Secondary	Physical Functioning Score	Increase in Physical Functioning Score measured by the SF-36V2. 10 items in this scale represent levels and kinds of limitations between the extremes of physical activities, including lifting and carrying groceries; climbing stairs; bending, kneeling or stooping and walking moderate distances. One self-care item is included to represent limitations in self-care activities. This scale captures both the presence and existent of physical limitations using a three-level response continuum. Low scores indicate significant limitations in performing physical activities, while high scores reflect little or no such limitations.	Baseline, week 4, 8, 12 and 16
Secondary	Mental Health Score	Increase in Mental Health (MH) Score measured by the SF-36V2. This 5-item scale includes one or more items from each of four major mental health dimensions (anxiety, depression, loss of behavioral/emotional control, and psychological wellbeing). Low scores on MH are indicative of frequent feelings of nervousness and depression, while high scores indicate feelings of peace, happiness, and calm all or most of the time.	Baseline, week 4, 8, 12 and 16
Secondary	Social Functioning Score	Increase in Social Functioning (SF) Score measured by the SF-36V2. This 2-item scale assesses health-related effects on quantity and quality of social activities, asking specifically either physical or emotional problems on social activities. The degree to which physical and emotional problems interfere with normal social actives increases with decreasing SF scores. The lowest score is related to extreme or frequent interference with normal social actives due to physical and emotional problems; the highest score indicates that the individual performs normal social activities without interference from physical or emotional problems..	Baseline, week 4, 8, 12 and 16
Secondary	Physical Health-related Role Limitations	Decrease in Physical Health-related Role Limitations measured by the SF-36V2. This 4-item scale covers an array of physical health-related role limitations, including a) limitations in the kind of work or other usual activities, b) reduction in the amount of time spend on work or other usual activities, c) difficulty performing work or other usual activities, and d) accomplishing less. Low scores on this scale reflect problems with work or other actives as a result of physical problems. High scores indicate little or no problems with work or other daily activities.	Baseline, week 4, 8, 12 and 16
Secondary	Depression Score	Improvement in Depression score measured by the Patient Health Questionnaire (PHQ-9). The PHQ-9 depression severity is calculated by assigning scores of 0, 1, 2, and 3, to the response categories of 'not at all', 'several days', 'more than half the days', and 'nearly every day', respectively. PHQ-9 total score for the nine items ranges from 0 to 27. Scores of 5, 10, 15, and 20 represent cutpoints for mild, moderate, moderately severe and severe depression, respectively.	Baseline, week 4, 8, 12 and 16
Secondary	Anxiety Score	Improvement in Depression score measured by the Generalized Anxiety Disorder (GAD-7). This is calculated by assigning scores of 0, 1, 2, and 3, to the response categories of 'not at all', 'several days', 'more than half the days', and 'nearly every day', respectively. GAD-7 total score for the seven items ranges from 0 to 21. Scores of 5, 10, and 15 represent cutpoints for mild, moderate, and severe anxiety, respectively.	Baseline, week 4, 8, 12 and 16
Secondary	Sleep Quality	Improvement in the Sleep Quality Score measured by the Insomnia Severity Index (ISI).Improvement in the Sleep Quality Score measured by the Insomnia Severity Index (ISI). Seven question added to get total score (0-28). Score of 0-7 has no clinically significant insomnia, 8-14 subthreshold insomnia, 15-21 clinical insomnia - moderate severity and 22-28 clinical insomnia - severe.	Baseline, week 4, 8, 12 and 16
Secondary	Pain Medication	Decrease in prescription pain medication use. Measured by recording initial and changes in prescription medication names, dose and frequency	Baseline, week 4, 8, 12 and 16
Secondary	Other non-pain prescription medications	Decrease in other no-pain prescription medications. Measured by recording initial and changes in non-prescription medications names, dose and frequency	Baseline, week 4, 8, 12 and 16
Secondary	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	Baseline, week 4, 8 and 12