Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06454669
Status:
RECRUITING
Last Update Posted:
2024-06-12
First Post:
2024-04-18
Brief Title:
Dronabinol as an Adjunct for Reducing Pain
Sponsor:
Christopher D Verrico
Organization:
Baylor College of Medicine
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Parallel Groups Study to Explore the Safety and Therapeutic Potential of Dronabinol as an Adjunct for Reducing Pain
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
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:
DARP
Brief Summary:
This exploratory proof-of-concept study is a double-blind participants and investigators will be blinded placebo-controlled randomized two-arm clinical trial of Marinol dronabinol synthetic Δ9-tetrahydrocannabinol THC for chronic low back pain cLBP with a 21 allocation ratio Up to 75 subjects will be enrolled in this pilot study and randomized to receive doses of THC up to 30 mgday orally over 8 weeks This study will be conducted at a single site it does not include any stratifications and there is no interim analysis planned Notably the goal is to determine whether there is enough evidence of the safety of THC to support the development of later-phase clinical trials Thus detailed developmental plans are contingent on the outcomes of this study
Detailed Description:
Musculoskeletal pain can be due to an injury to the bones joints muscles tendons ligaments or nerves which can be caused by jerking movements car accidents falls fractures sprains dislocations and direct blows to the muscle Musculoskeletal pain can be localized in one area or widespread Lower back pain is the most common type of musculoskeletal pain Other common types include tendonitis myalgia muscle pain and stress fractures A review of opioids for non-cancer musculoskeletal diseases concluded that opioids were only slightly more effective than their placebos no more effective than acetaminophen and somewhat less effective than nonsteroidal anti-inflammatory drugs In fact the Centers for Disease Control CDC recommends that opioids should not be considered an option for chronic musculoskeletal pain The impact of cannabinoid treatments on pain in human volunteers has been evaluated for 1 experimentally induced acute pain 2 acute postsurgical pain and 3 chronic pain Collectively these data suggest that cannabinoids may be more effective for chronic rather than acute pain conditions However there have been few randomized double-blind placebo-controlled clinical trials RCTs the Gold Standard in intervention-based studies of cannabinoids for pain To this end the proposed study will contribute to the evidence base concerning the potential utility of treating chronic low back pain cLBP with cannabinoids
Four RCTs in 159 patients with fibromyalgia osteoarthritis chronic back pain and rheumatoid arthritis treated with oral cannabinoids nabilone THCcannabidiol CBD and fatty acid amide hydrolase FAAH inhibitor placebo or active control amitriptyline were included in a systemic review The results were inconsistent and did not reveal whether the cannabinoids were superior to the controls placebo and amitriptyline The authors concluded that there is insufficient evidence for the recommendation for cannabinoid use for pain management in patients with rheumatic diseases Since then a Phase II RCT 65 participants found no difference between THC and placebo in reducing pain measures in patients with chronic abdominal pain due to surgery or chronic pancreatitis
A more recent systematic review and meta-analysis aimed to analyze the evidence surrounding the benefits and harms of medical cannabinoids in the treatment of chronic non-cancer-related pain Thirty-six trials 4006 participants were included examining smoked cannabis 4 trials oromucosal cannabis sprays 14 trials and oral cannabinoids 18 trials Of the 18 trials that examined oral cannabinoids 15 examined synthetic THC in the form of dronabinol n9 nabilone n4 or nasimol n2 Treatment durations ranged from 1 day to 6 months Across the 29 trials 34 comparisons that had reported on pain outcomes there was a significant treatment effect favoring the use of cannabinoids over placebo -063 95 confidence interval CI -085 to -042 I2 16 P 000001 Compared with placebo cannabinoids showed a significant reduction in pain which was greatest with treatment duration of 2 to 8 weeks weighted mean difference on a 0-10 pain visual analog scale -068 95 CI -096 to -040 I2 8 P 000001 n 16 trials Across all time points oral formulations demonstrated a superior effect compared with oromucosal and inhaled routes of administration Serious AEs were rare and similar across the cannabinoid 74 out of 2176 34 and placebo groups 53 out of 1640 32 There was an increased risk of non-serious adverse events AEs with cannabinoids compared with placebo Overall the authors found that cannabinoids are an effective form of pain control in this patient population with a particularly strong effect among those cannabinoids that are orally administered However these studies were found to be limited by overall quality which were largely underpowered selective and inconsistent in their reporting This preliminary evidence of effectiveness indicates the need for high-quality RCTs in orthopedic areas
The FDA has not approved a cannabinoid medication to treat cLBP Here the investigators propose to study the effects of THC for several reasons First although both smoked cannabis and THC decrease pain sensitivity increase pain tolerance and decrease subjective ratings of pain intensity THC produces more consistent analgesia for a longer duration Second the therapeutic effects of cannabinoids are best established for THC Third defined substances such as purified cannabinoid compounds are preferable to plant products which are of variable and uncertain composition Use of defined cannabinoids permits a more precise evaluation of their effects whether combined or alone Finally compared with marijuana THC produces lower ratings of abuse-related subjective effects which can be predictive of use and abuse patterns Hence the investigators have elected to study THC The primary objective of this double-blind randomized placebo-controlled 1-site study is to explore the safety and tolerability of THC versus placebo when orally administered to patients suffering from chronic pain
Four RCTs in 159 patients with fibromyalgia osteoarthritis chronic back pain and rheumatoid arthritis treated with oral cannabinoids nabilone THCcannabidiol CBD and fatty acid amide hydrolase FAAH inhibitor placebo or active control amitriptyline were included in a systemic review The results were inconsistent and did not reveal whether the cannabinoids were superior to the controls placebo and amitriptyline The authors concluded that there is insufficient evidence for the recommendation for cannabinoid use for pain management in patients with rheumatic diseases Since then a Phase II RCT 65 participants found no difference between THC and placebo in reducing pain measures in patients with chronic abdominal pain due to surgery or chronic pancreatitis
A more recent systematic review and meta-analysis aimed to analyze the evidence surrounding the benefits and harms of medical cannabinoids in the treatment of chronic non-cancer-related pain Thirty-six trials 4006 participants were included examining smoked cannabis 4 trials oromucosal cannabis sprays 14 trials and oral cannabinoids 18 trials Of the 18 trials that examined oral cannabinoids 15 examined synthetic THC in the form of dronabinol n9 nabilone n4 or nasimol n2 Treatment durations ranged from 1 day to 6 months Across the 29 trials 34 comparisons that had reported on pain outcomes there was a significant treatment effect favoring the use of cannabinoids over placebo -063 95 confidence interval CI -085 to -042 I2 16 P 000001 Compared with placebo cannabinoids showed a significant reduction in pain which was greatest with treatment duration of 2 to 8 weeks weighted mean difference on a 0-10 pain visual analog scale -068 95 CI -096 to -040 I2 8 P 000001 n 16 trials Across all time points oral formulations demonstrated a superior effect compared with oromucosal and inhaled routes of administration Serious AEs were rare and similar across the cannabinoid 74 out of 2176 34 and placebo groups 53 out of 1640 32 There was an increased risk of non-serious adverse events AEs with cannabinoids compared with placebo Overall the authors found that cannabinoids are an effective form of pain control in this patient population with a particularly strong effect among those cannabinoids that are orally administered However these studies were found to be limited by overall quality which were largely underpowered selective and inconsistent in their reporting This preliminary evidence of effectiveness indicates the need for high-quality RCTs in orthopedic areas
The FDA has not approved a cannabinoid medication to treat cLBP Here the investigators propose to study the effects of THC for several reasons First although both smoked cannabis and THC decrease pain sensitivity increase pain tolerance and decrease subjective ratings of pain intensity THC produces more consistent analgesia for a longer duration Second the therapeutic effects of cannabinoids are best established for THC Third defined substances such as purified cannabinoid compounds are preferable to plant products which are of variable and uncertain composition Use of defined cannabinoids permits a more precise evaluation of their effects whether combined or alone Finally compared with marijuana THC produces lower ratings of abuse-related subjective effects which can be predictive of use and abuse patterns Hence the investigators have elected to study THC The primary objective of this double-blind randomized placebo-controlled 1-site study is to explore the safety and tolerability of THC versus placebo when orally administered to patients suffering from chronic pain
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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?:
None