Trial Summary
What is the purpose of this trial?This trial is testing THC and CBD on people with chronic non-cancer pain. THC can help reduce pain by affecting brain areas that process pain signals, while CBD may help by reducing inflammation and interacting with pain receptors. THC and CBD have been studied for their potential to manage chronic pain, with THC showing effectiveness in reducing pain signals and CBD being noted for its anti-inflammatory properties.
Do I have to stop taking my current medications for the trial?
The trial protocol does not specify if you need to stop taking your current medications.
What data supports the idea that CBD + THC for Chronic Pain is an effective drug?
The available research shows that a spray containing CBD and THC was effective in reducing chronic pain, especially neuropathic pain, in a study involving patients with severe chronic pain. After 12 weeks, many patients experienced significant pain relief, with 56% showing at least a 50% improvement in their symptoms. This suggests that CBD + THC can be a helpful option for managing chronic pain, particularly when other treatments haven't worked.
12345What safety data exists for CBD and THC in treating chronic pain?
Existing safety data for CBD and THC indicates that most adverse effects are mild to moderate, with rare serious adverse effects. CBD can interact with other drugs, potentially causing sedation, drowsiness, and other psychoactive effects. Serious adverse reactions have been reported, especially when used with other medications like antiepileptics. Common adverse effects include transaminase elevations, sedation, sleep disturbances, infection, and anemia. CBD's interactions with drug metabolism enzymes suggest a high potential for drug-drug interactions. More research is needed on reproductive and developmental toxicity and immune outcomes.
678910Is the drug Cannabidiol and Delta-9-Tetrahydrocannabinol (CBD and THC) promising for treating chronic pain?
Yes, the combination of CBD and THC shows promise as a treatment for chronic pain, especially for neuropathic pain. Studies suggest it can effectively reduce pain and is generally well-tolerated, making it a potential option for those who have not found relief with other treatments.
25111213Eligibility Criteria
This trial is for adults aged 18-50 with a history of cannabis use who suffer from chronic musculoskeletal and joint pain lasting at least 3 months. Participants must live within 60 miles of Salt Lake City, Utah.Inclusion Criteria
Participants must live within a 60 mile radius of Salt Lake City, Utah to be eligible
I have had joint or muscle pain for 3 months or more.
I am between 18 and 50 years old.
+1 more
Exclusion Criteria
Unstable medical conditions
Substance abuse or dependence within the prior 60 days
I have diabetes.
+8 more
Participant Groups
The study compares the effects on chronic non-cancer pain between three options: Delta-9-Tetrahydrocannabinol (THC), Cannabidiol (CBD), and a placebo to see which is more effective in managing pain.
3Treatment groups
Active Control
Placebo Group
Group I: Delta-9-Tetrahydrocannabinol's (Delta-9-THC) effects on painActive Control1 Intervention
This arm will be testing the analgesic effects of orally dosed Delta-9-Tetrahydrocannabinol on subjects with chronic non-cancer pain.
Group II: Cannabidiol's (CBD) effects on painActive Control1 Intervention
This arm will be testing the analgesic effects of orally dosed Cannabidiol on subjects with chronic non-cancer pain.
Group III: PlaceboPlacebo Group1 Intervention
This Placebo arm will act as the control as standard of care medications will be continued through the study. This arm will allow us to compare the analgesic effects of the other two arms with the standard of care treatments for chronic non-cancer pain.
Cannabidiol is already approved in United States, European Union, Canada for the following indications:
πΊπΈ Approved in United States as Epidiolex for:
- Seizures associated with Lennox-Gastaut syndrome
- Seizures associated with Dravet syndrome
- Seizures associated with tuberous sclerosis complex
πͺπΊ Approved in European Union as Epidiolex for:
- Seizures associated with Lennox-Gastaut syndrome
- Seizures associated with Dravet syndrome
- Seizures associated with tuberous sclerosis complex
π¨π¦ Approved in Canada as Epidiolex for:
- Seizures associated with Lennox-Gastaut syndrome
- Seizures associated with Dravet syndrome
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University Of UtahSalt Lake City, UT
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Who Is Running the Clinical Trial?
University of UtahLead Sponsor
References
Topical cannabidiol is well tolerated in individuals with a history of elite physical performance and chronic lower extremity pain. [2023]Cannabidiol (CBD) is a potential therapeutic for pain management. Yet, there exists a dearth of studies of its tolerability and efficacy, especially in special populations. Former elite athletes are a special population both susceptible to chronic pain and also highly trained and attuned to assess medication tolerability concerns. The purpose of the present open-label pilot study was to assess the tolerability of CBD in this population.
Effectiveness and tolerability of THC:CBD oromucosal spray as add-on measure in patients with severe chronic pain: analysis of 12-week open-label real-world data provided by the German Pain e-Registry. [2020]Objective: To evaluate effectiveness, tolerability and safety of an oromucosal spray containing Δ9-tetrahydrocannabinol (THC) and cannabidiol (CBD), as add-on treatment in patients with severe chronic pain (SCP). Methods: Exploratory analysis of anonymized 12-week routine/open-label data provided by the German Pain e-Registry (GPR) on adult SCP patients treated with THC:CBD oromucosal spray in 2017. Results: Among those 30.228 cases documented in the GPR in 2017, 800 (2.6%; 57% female, mean ± SD age: 46.3±9.7 years) received a treatment with THC:CBD. All patients fulfilled the legislative preconditions for a treatment with cannabis as medicine as defined by the German Act Amending Narcotics and Other Regulations. THC:CBD-treatment was followed by an aggregated nine-factor symptom relief (ASR-9) improvement at end of week 12 vs baseline of 39.0±26.5% (95%-CI: 36.9-41.1, median: 42, range -41 to 85). A full ASR-9 response (ie, a 50%-improvement in all 9 factors) was found for 123 patients (15.4%), while 488 patients (56.0%) presented with an ≥50% improvement in at least 5 of 9 ASR factors. With a 54.9±17.2% (median: 56%, range: -6 to 85) improvement was significantly superior in the neuropathic pain subgroup (n=497, 62.1%) vs those with mixed (n=249, 31.1%; ASR-9: 18.2±12.0, median: 19, range: -12 to 42%) or nociceptive pain (n=54, 6.8%; ASR-9: -11.9±10.5, median: -11, range: -41% to 12%; p<0.001 for each). 159 patients (19.9%) reported at least one of 206 TEAEs, most of them of mild intensity (n=81.6%). Most frequently reported TEAEs were increased appetite (n=50, 6.3%) and dysgeusia (n=23, 2.9%). TEAE-related discontinuations were reported for 32 patients (4.0%). 113 (14.1%) patients discontinued due to inadequate pain relief, most of them with nociceptive pain (n=40, 74.1%), least with neuropathic pain (n=1, 0.2%; p<0.001). Conclusion: THC:CBD oromucosal spray proved to be an effective and well-tolerated add-on treatment for patients with elsewhere refractory chronic pain - especially of neuropathic origin.
A placebo-controlled investigation of the analgesic effects, abuse liability, safety and tolerability of a range of oral cannabidiol doses in healthy humans. [2022]Preclinical studies demonstrate that cannabidiol (CBD) elicits an antinociceptive response in animal models of neuropathic pain; in humans, limited data are available to support such analgesic effects. Few studies have examined CBD's analgesic effects when administered without other compounds, and little is known regarding dose-dependent effects in noncannabis users.
A double-blind, randomized, placebo-controlled, parallel group study of THC/CBD spray in peripheral neuropathic pain treatment. [2022]Peripheral neuropathic pain (PNP) associated with allodynia poses a significant clinical challenge. The efficacy of Ξ(9) -tetrahydrocannabinol/cannabidiol (THC/CBD) oromucosal spray, a novel cannabinoid formulation, was investigated in this 15-week randomized, double-blind, placebo-controlled parallel group study.
Tolerability and Efficacy of a 10:25 Preparation of Ξ9-Tetrahydrocannabinol and Cannabidiol for Treatment of Chronic Back or Neck Pain: A Multiple-Dose Escalation Study. [2023]The aim was to demonstrate the safety and tolerability of cannabidiol (CBD) with Ξ9-THC in patients with moderate to severe chronic back or neck pain unresponsive to over-the-counter non-opioid analgesics.
Serious adverse effects of cannabidiol (CBD): a review of randomized controlled trials. [2022]Recent trials using cannabidiol (CBD) have shown that most acute and prolonged adverse effects of CBD are mild to moderate, with rare serious adverse effects (SAEs). This review focused on analyzing SAEs of CBD and their possible relation to drug-drug interactions.
Pharmacovigilance of unlicensed cannabidiol in European countries. [2023]Cannabidiol (CBD) is a multitarget agent possessing anti-inflammatory and antioxidant properties. Unlicensed CBD gained public favor for the care of general health and well-being as well as to get comfort from inflammatory complaints, pain, anxiety, mood, and sleep disorders. Safety profile of unlicensed CBD has been not sufficiently described. For this reason, suspected adverse reactions (SARs) to CBD unlicensed products were analyzed. Serious SARs to unlicensed CBD products in EudraVigilance, a system purchased by the European Medicines Agency, were analyzed for age, sex of the patient, adverse reactions, indication for use, and concomitant drugs. Serious SARs were 18.9% of all adverse events to unlicensed CBD; they were more frequent in men and adult people and, to a less extent, in children (3-11 years). About sex, in EudraVigilance serious Individual Cases Safety Reports of SARs to CBD in men are in the largest number (58.8%) with respect to women. Unlicensed CBD was used in the 38.8% of cases for treatment of epilepsy; more frequent adverse effects were: mental disorders, hepatic disorders, and aggravation of pre-existing epilepsy. Drugs or substances more frequently associated with SARs were the antiepileptics clobazam and valproic acid, followed by cannabis. Results suggest that precautions and appropriate surveillance of adverse effects should be taken when unlicensed CBD is used.
[Pharmacology of cannabidiol: Red flags, consequences and risks in humans]. [2023]Scientific knowledge about cannabidiol (CBD) demonstrates that CBD is a substance that is not pharmacologically inert. If it does not act efficiently on cannabinoid receptors (those where tetrahydrocannabidol [THC] is fixed), it acts on brain receptors, especially on dopamine and serotonin receptors, making it a psychoactive product in its own right. Its consumption can thus have psychoactive effects, such as sedation and drowsiness for example. In humans, interactions between CBD and drugs such as anti-epileptics, anticoagulants, immunosuppressants or methadone, have been highlighted. Therefore, the drug treatment of patients with chronic diseases may be impacted because of the unknown interaction with CBD. In addition, a recent experimental study has shown that the use of CBD by vaping (e-cigarette) generated by pyrolysis, products containing THC; it could result in possible negative health consequences for the user in terms of clinical effects and/or collateral effects (including on driving). Finally, therapeutic claims (outside of authorized drugs) that are purely speculative at this stage may divert users from proven management (stopping their drug treatment in favor of CBD or "self-medication"). All these data underline the importance of implementing measures related to the accessibility of CBD in order to avoid public health consequences and to better protect the users.
Potential Adverse Drug Events and Drug-Drug Interactions with Medical and Consumer Cannabidiol (CBD) Use. [2020]Cannabidiol (CBD) is ubiquitous in state-based medical cannabis programs and consumer products for complementary health or recreational use. CBD has intrinsic pharmacologic effects and associated adverse drug events (ADEs) along with the potential for pharmacokinetic and pharmacodynamic drug-drug interactions (DDIs). Given CBD use among patients with complex conditions and treatment regimens, as well as its expanded consumer use, awareness of potential safety issues with CBD is needed. Prescribing information for federally approved products containing CBD were reviewed. Data on ADEs and DDIs were extracted and summarized. Nearly one-half of CBD users experienced ADEs, which displayed a general dose-response relationship. Common ADEs include transaminase elevations, sedation, sleep disturbances, infection, and anemia. Given CBD effects on common biological targets implicated in drug metabolism (e.g., CYP3A4/2C19) and excretion (e.g., P-glycoprotein), the potential for DDIs with commonly used medication is high. General clinical recommendations of reducing substrate doses, monitoring for ADEs, and finding alternative therapy should be considered, especially in medically complex patients. CBD is implicated as both a victim and perpetrator of DDIs and has its own ADE profile. These effects should be considered in the risk-benefit assessment of CBD therapy and patients and consumers made aware of potential safety issues with CBD use.
Cannabidiol Safety Data: A Systematic Mapping Study. [2023]Robust assessment of potential adverse outcomes is needed to determine a safe cannabidiol (CBD) intake level for consumer use. To assist in identifying knowledge gaps and inform future decision making regarding systematic development of health-based benchmarks, we have developed the first systematic map of the safety-related information available for CBD in the peer-reviewed literature. Literature searching conducted according to a published protocol yielded a total of 4186 unique titles and abstracts published through 2020. These were screened using DistillerSR for studies that evaluated at least one potential health outcome following exposure to CBD and/or other hemp-derived substances. Additional categorization was conducted for a subset of 1001 studies in which CBD was administered alone. Studies that investigated CBD most frequently reported on neurological outcomes (532), carcinogenic outcomes (129), and pharmacokinetics (118). Less frequently studied categories included developmental and reproductive, hepatic, and gastrointestinal outcomes. The primary outcomes associated with the most adverse events reported in the literature were neurological (13) and developmental and reproductive (12). Based on the studies identified, reproductive and developmental toxicity was identified as a data gap that warrants conducting a well-designed, guideline-compliant reproductive toxicity study on CBD. In addition, immune outcomes were noted as a potential emerging research area for CBD. This systematic map provides an important baseline from which to identify topics that may be suitable for further research related to the safe use of CBD. Implications for future potential work and limitations of the mapping exercise are discussed.
A Review of Scientific Evidence for THC:CBD Oromucosal Spray (Nabiximols) in the Management of Chronic Pain. [2020]The 20% prevalence of chronic pain in the general population is a major health concern given the often profound associated impairment of daily activities, employment status, and health-related quality of life in sufferers. Resource utilization associated with chronic pain represents an enormous burden for healthcare systems. Although analgesia based on the World Health Organization's pain ladder continues to be the mainstay of chronic pain management, aside from chronic cancer pain or end-of-life care, prolonged use of non-steroidal anti-inflammatory drugs or opioids to manage chronic pain is rarely sustainable. As the endocannabinoid system is known to control pain at peripheral, spinal, and supraspinal levels, interest in medical use of cannabis is growing. A proprietary blend of cannabis plant extracts containing delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD) as the principal cannabinoids is formulated as an oromucosal spray (USAN name: nabiximols) and standardized to ensure quality, consistency and stability. This review examines evidence for THC:CBD oromucosal spray (nabiximols) in the management of chronic pain conditions. Cumulative evidence from clinical trials and an exploratory analysis of the German Pain e-Registry suggests that add-on THC:CBD oromucosal spray (nabiximols) may have a role in managing chronic neuropathic pain, although further precise clinical trials are required to draw definitive conclusions.
Tetrahydrocannabinol and cannabidiol medicines for chronic pain and mental health conditions. [2022]Combination tetrahydrocannabinol (THC)/cannabidiol (CBD) medicines or CBD-only medicines are prospective treatments for chronic pain, stress, anxiety, depression, and insomnia. THC and CBD increase signaling from cannabinoid receptors, which reduces synaptic transmission in parts of the central and peripheral nervous systems and reduces the secretion of inflammatory factors from immune and glial cells. The overall effect of adding CBD to THC medicines is to enhance the analgesic effect but counteract some of the adverse effects. There is substantial evidence for the effectiveness of THC/CBD combination medicines for chronic pain, especially neuropathic and nociplastic pain or pain with an inflammatory component. For CBD-only medication, there is substantial evidence for stress, moderate evidence for anxiety and insomnia, and minimal evidence for depression and pain. THC/CBD combination medicines have a good tolerability and safety profile relative to opioid analgesics and have negligible dependence and abuse potential; however, should be avoided in patients predisposed to depression, psychosis and suicide as these conditions appear to be exacerbated. Non-serious adverse events are usually dose-proportional, subject to tachyphylaxis and are rarely dose limiting when patients are commenced on a low dose with gradual up-titration. THC and CBD inhibit several Phase I and II metabolism enzymes, which increases the exposure to a wide range of drugs and appropriate care needs to be taken. Low-dose CBD that appears effective for chronic pain and mental health has good tolerability and safety, with few adverse effects and is appropriate as an initial treatment.
Cannabidiol and Delta-9-Tetrahydrocannabinol Interactions in Male and Female Rats With Persistent Inflammatory Pain. [2023]Cannabidiol (CBD) and delta-9-tetrahydrocannabinol (THC), 2 of the primary constituents of cannabis, are used by some individuals to self-treat chronic pain. It is unclear whether the pain-relieving effects of CBD alone and in combination with THC are consistent across genders and among types of pain. The present study compared the effects of CBD and THC given alone and in combination in male and female rats with Complete Freund's adjuvant-induced inflammatory pain. After induction of hindpaw inflammation, vehicle, CBD (0.05-2.5 mg/kg), THC (0.05-2.0 mg/kg), or a CBD:THC combination (3:1, 1:1, or 1:3 dose ratio) was administered i.p. twice daily for 3 days. Then on day 4, mechanical allodynia, thermal hyperalgesia, weight-bearing, and locomotor activity were assessed 0.5 to 4 hours after administration of the same dose combination. Hindpaw edema and open field (anxiety-like) behaviors were measured thereafter. THC alone was anti-allodynic and anti-hyperalgesic, and decreased paw thickness, locomotion, and open field behaviors. CBD alone was anti-allodynic and anti-hyperalgesic. When combined with THC, CBD tended to decrease THC effects on pain-related behaviors and exacerbate THC-induced anxiety-like behaviors, particularly in females. These results suggest that at the doses tested, CBD-THC combinations may be less beneficial than THC alone for the treatment of chronic inflammatory pain. PERSPECTIVE: The present study compared CBD and THC effects alone and in combination in male and female rats with persistent inflammatory pain. This study could help clinicians who prescribe cannabis-based medicines for inflammatory pain conditions determine which cannabis constituents may be most beneficial.