Ignite Creation Date:
2025-12-25 @ 1:03 AM
Ignite Modification Date:
2026-01-05 @ 6:32 PM
Study NCT ID:
NCT03635593
Status:
UNKNOWN
Last Update Posted:
2018-11-13
First Post:
2018-08-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cannabis Oil for Chronic Non-Cancer Pain Treatment
Sponsor:
Hamilton Health Sciences Corporation
Organization:
Study Overview
Official Title:
Cannabis Oil for Chronic Non-CancEr Pain Treatment [CONCEPT] - Alpha (α): A Randomized Controlled Trial
Status:
UNKNOWN
Status Verified Date:
2018-11
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CONCEPT
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: