Cannabis for Pain Relief
(CanSex Trial)
Recruiting in Palo Alto (17 mi)
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Recruiting
Sponsor: University of California, Los Angeles
Must not be taking: Medical cannabis, Prescription analgesics
Disqualifiers: Substance use disorder, Severe psychiatric illness, others
Trial Summary
What is the purpose of this trial?This trial is studying the effects of smoking cannabis on pain relief and potential abuse in men and women. Researchers are comparing how different doses affect each sex and how their bodies process THC, the active ingredient in cannabis. The goal is to understand if there are significant differences between men and women in these effects.
Will I have to stop taking my current medications?
Yes, you will need to stop taking any prescription pain medications or medical cannabis, as well as any other medications that might affect the study's results.
What data supports the effectiveness of the drug Cannabis for pain relief?
Research shows that cannabinoids, a component of cannabis, can provide a small but significant reduction in acute pain, especially when administered intramuscularly. Additionally, vaporized cannabis has been found to significantly reduce neuropathic pain in patients with spinal cord injuries.
12345Is cannabis safe for pain relief in humans?
Cannabis and cannabis-based medicines have been studied for pain relief, showing some adverse effects like dizziness, but serious side effects are rare. While some studies suggest cannabis may be safe for short-term use, the overall quality of evidence is low, and more research is needed to confirm long-term safety.
13678How does the drug cannabis differ from other treatments for pain relief?
Cannabis for pain relief is unique because it involves the use of cannabinoids, which are compounds found in the cannabis plant, and can be administered in various forms such as inhaled or as extracts. Unlike traditional pain medications, cannabis offers a different mechanism of action by interacting with the body's endocannabinoid system, and it includes options like CBD, which does not cause a 'high' and is not a controlled substance.
2391011Eligibility Criteria
This trial is for men and women aged 21-55 who use cannabis weekly but aren't seeking treatment for it. Women must have regular cycles and use non-hormonal birth control. Participants should be healthy, with a BMI of 18.5 - 34kg/m2, and able to do all study tasks.Inclusion Criteria
I have regular menstrual cycles.
Have a Body Mass Index from 18.5 - 34kg/m2
I can participate in all required study activities.
+7 more
Exclusion Criteria
I am using hormonal birth control.
History or current evidence of severe psychiatric illness or medical condition judged by the study physician and PI to put the participant at greater risk of experiencing adverse events due to completion of study procedures, interfere with their ability to participate in the study, or their capacity to provide informed consent
I am currently using medical cannabis, painkillers, or other medications that could influence the study.
+4 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive smoked cannabis with varying THC strengths to assess analgesic and abuse-related effects
5 hours per session
Multiple sessions
Follow-up
Participants are monitored for safety and effectiveness after treatment
1-2 weeks
Participant Groups
The CanSex study is testing the effects of actual cannabis versus placebo on pain relief and potential abuse in both men and women to understand if there are sex differences in these responses.
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Low strength cannabisExperimental Treatment1 Intervention
Smoked Cannabis (\~4% THC)
Group II: Higher strength cannabisExperimental Treatment1 Intervention
Smoked Cannabis (\~10% THC)
Group III: PlaceboPlacebo Group1 Intervention
Smoked Cannabis (\~0% THC)
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of California, Los AngelesLos Angeles, CA
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Who Is Running the Clinical Trial?
University of California, Los AngelesLead Sponsor
National Institute on Drug Abuse (NIDA)Collaborator
References
Cannabinoids in the Management of Acute Pain: A Systematic Review and Meta-analysis. [2023]Objective: To synthesize the best evidence surrounding the efficacy of cannabinoids for acute pain in the clinical setting based on subjective pain scores and observed adverse effects. Design: Systematic review with meta-analysis. Data Sources: PubMed, Embase, Cochrane Databases, and Google Scholar. Eligibility Criteria: English-language randomized-controlled clinical trials comparing cannabinoids with placebo in patients with acute pain. Data Extraction and Synthesis: Study quality was assessed using the Cochrane risk of bias tool. All stages were conducted independently by a team of three reviewers. Data were pooled through meta-analysis and stratified by route of administration. Primary Outcomes and Measures: Patient-reported pain and adverse events (AEs). Results: Six trials (678 participants) were included examining oral (5 trials) and intramuscular (1 trial) cannabinoids. Overall, there was a small but statistically significant treatment effect favoring the use of cannabinoids over placebo (-0.90, 95% confidence interval [CI] -1.69 to -0.1, i 2=65%, p=0.03). When stratified by route of administration, intramuscular cannabinoids were found to have a significant reduction in pain relative to placebo (-2.98, 95% CI -4.09 to -1.87, i 2=0%, p<0.0001). No difference in effect was observed between oral cannabinoids and placebo (-0.21, 95% CI -0.64 to 0.22, i 2=3%, p=0.34). Serious AEs were rare, and similar across the cannabinoid (14/374, 3.7%) and placebo groups (8/304, 2.6%). Conclusions: There is low-quality evidence indicating that cannabinoids may be a safe alternative for a small but significant reduction in subjective pain score when treating acute pain, with intramuscular administration resulting in a greater reduction relative to oral. Higher quality, long-term randomized-controlled trials examining whether there may be a role for cannabinoids in treating acute pain are required.
Medicinal cannabis products for the treatment of acute pain. [2023]For thousands of years, medicinal cannabis has been used for pain treatment, but its use for pain management is still controversial. Meta-analysis of the literature has shown contrasting results on the addition of cannabinoids to opioids compared with placebo/other active agents to reduce pain. Clinical studies are mainly focused on medicinal cannabis use in chronic pain management, for which the analgesic effect has been proven in many studies. This review focuses on the potential use of medical cannabis for acute pain management in preclinical studies, studies on healthy subjects and the few pioneering studies in the clinical setting.
Are cannabinoids an effective and safe treatment option in the management of pain? A qualitative systematic review. [2022]To establish whether cannabis is an effective and safe treatment option in the management of pain.
[Evidence of the efficacy and safety of cannabis medicines for chronic pain management : A methodological minefield]. [2019]Recent systematic reviews (SRs) came to divergent conclusions on the efficacy and safety of medical marijuana and cannabis-based medicines for chronic pain management. This paper gives an overview and critical appraisal of the methods of recent SRs of randomized controlled trials (RCTs) with cannabis medicines for chronic pain.Selective search of the literature, incorrect data analyses and presentation in favor of cannabis medicines can be detected in both RCTs and SRs. The more detailed the search of literature (e.g. inclusion of so-called grey literature) and the higher the criteria of the inclusion of studies (such as study duration) and of the clinical relevance of the study findings, the more disappointing are the conclusions of SRs on the efficacy and safety of cannabis medicines. There is moderate quality evidence of a moderate relief of neuropathic pain. Cannabis medicines can be regarded to be third-line therapy for chronic neuropathic pain. There are signals of a lack of efficacy for all other chronic pain syndromes.New high-quality RCTs and approaches, such as network meta-analyses combining different treatments and controlled and observational including additional outcomes than pain relief, are necessary to better define the importance of cannabis medicines for chronic pain management.
An Exploratory Human Laboratory Experiment Evaluating Vaporized Cannabis in the Treatment of Neuropathic Pain From Spinal Cord Injury and Disease. [2019]Using 8-hour human laboratory experiments, we evaluated the analgesic efficacy of vaporized cannabis in patients with neuropathic pain related to injury or disease of the spinal cord, most of whom were experiencing pain despite traditional treatment. After obtaining baseline data, 42 participants underwent a standardized procedure for inhaling 4 puffs of vaporized cannabis containing either placebo, 2.9%, or 6.7% delta 9-THC on 3 separate occasions. A second dosing occurred 3 hours later; participants chose to inhale 4 to 8 puffs. This flexible dosing was used to attempt to reduce the placebo effect. Using an 11-point numerical pain intensity rating scale as the primary outcome, a mixed effects linear regression model showed a significant analgesic response for vaporized cannabis. When subjective and psychoactive side effects (eg, good drug effect, feeling high, etc) were added as covariates to the model, the reduction in pain intensity remained significant above and beyond any effect of these measures (all P
Cannabinoids, cannabis, and cannabis-based medicine for pain management: a systematic review of randomised controlled trials. [2023]Cannabinoids, cannabis, and cannabis-based medicines (CBMs) are increasingly used to manage pain, with limited understanding of their efficacy and safety. We summarised efficacy and adverse events (AEs) of these types of drugs for treating pain using randomised controlled trials: in people of any age, with any type of pain, and for any treatment duration. Primary outcomes were 30% and 50% reduction in pain intensity, and AEs. We assessed risk of bias of included studies, and the overall quality of evidence using GRADE. Studies of 7 days treatment duration were analysed separately. We included 36 studies (7217 participants) delivering cannabinoids (8 studies), cannabis (6 studies), and CBM (22 studies); all had high and/or uncertain risk of bias. Evidence of benefit was found for cannabis 7 days (risk difference 0.06, 95% confidence interval 0.01-0.12; 6 trials, 1484 patients, very low-quality evidence). No other beneficial effects were found for other types of cannabinoids, cannabis, or CBM in our primary analyses; 81% of subgroup analyses were negative. Cannabis, nabiximols, and delta-9-tetrahydrocannabinol had more AEs than control. Studies in this field have unclear or high risk of bias, and outcomes had GRADE rating of low- or very low-quality evidence. We have little confidence in the estimates of effect. The evidence neither supports nor refutes claims of efficacy and safety for cannabinoids, cannabis, or CBM in the management of pain.
The Quebec Cannabis Registry: Investigating the Safety and Effectiveness of Medical Cannabis. [2023]Objective: To investigate the safety and effectiveness of medical cannabis (MC) in the real-world clinical practice setting. Design: A 4-year prospective noncomparative registry of adult patients who initiated MC for a variety of indications. This paper reports on patients followed for up to 12 months, with interim visits at 3, 6, and 9 months after enrollment. Setting: Public or private outpatient clinics certified to authorize MC in the province of Quebec, Canada. Participants: Overall, 2991 adult (age ≥18 years) patients (mean age 51 years; 50.2% women) were enrolled between May 2015 and October 2018, with the last follow-up ending in May 2019. Interventions/Exposures: Cannabis products (dried, oil, or other) purchased from a Canadian licensed cannabis producer as authorized by physicians. Main Outcome Measures: The primary outcomes were self-reported pain severity, interference and relief (Brief Pain Inventory [BPI]), symptoms using the Revised Edmonton Symptom Assessment System (ESAS-r) and health-related quality of life dimensions (EQ-5D-5L) at baseline and each follow-up visit. The secondary outcomes were self-reported adverse events (AEs) and characteristics of cannabis treatment. Results: All patient-reported outcomes (BPI, ESAS-r, and EQ-5D-5L) showed a statistically significant improvement at 3 months (all p<0.01), which was maintained or further improved (for pain interference, tiredness, and well-being) over the remainder of the 12-month follow-up. Results also revealed clinically significant improvements in pain interference and tiredness, anxiety, and well-being from baseline. There were 79 AE reports (77 patients), 16 met the regulatory definition of seriousness, in which only 8 AEs were certainly or probably related to MC. Conclusions: MC directed by physicians appears to be safe and effective within 3 months of initiation for a variety of medical indications.
The pharmacologic and clinical effects of medical cannabis. [2022]Cannabis, or marijuana, has been used for medicinal purposes for many years. Several types of cannabinoid medicines are available in the United States and Canada. Dronabinol (schedule III), nabilone (schedule II), and nabiximols (not U.S. Food and Drug Administration approved) are cannabis-derived pharmaceuticals. Medical cannabis or medical marijuana, a leafy plant cultivated for the production of its leaves and flowering tops, is a schedule I drug, but patients obtain it through cannabis dispensaries and statewide programs. The effect that cannabinoid compounds have on the cannabinoid receptors (CB(1) and CB(2) ) found in the brain can create varying pharmacologic responses based on formulation and patient characteristics. The cannabinoid Δ(9) -tetrahydrocannabinol has been determined to have the primary psychoactive effects; the effects of several other key cannabinoid compounds have yet to be fully elucidated. Dronabinol and nabilone are indicated for the treatment of nausea and vomiting associated with cancer chemotherapy and of anorexia associated with weight loss in patients with acquired immune deficiency syndrome. However, pain and muscle spasms are the most common reasons that medical cannabis is being recommended. Studies of medical cannabis show significant improvement in various types of pain and muscle spasticity. Reported adverse effects are typically not serious, with the most common being dizziness. Safety concerns regarding cannabis include the increased risk of developing schizophrenia with adolescent use, impairments in memory and cognition, accidental pediatric ingestions, and lack of safety packaging for medical cannabis formulations. This article will describe the pharmacology of cannabis, effects of various dosage formulations, therapeutics benefits and risks of cannabis for pain and muscle spasm, and safety concerns of medical cannabis use.
The Role of Cannabis, Cannabidiol and Other Cannabinoids in Chronic Pain. The Perspective of Physicians. [2023]Currently, there is a renewed interest in treatments with medical cannabis and cannabinoids. Based on an increasing number of publications over the last decades that permitted new insights into mechanisms, efficacy and safety of cannabinoids, the use of cannabinergic medications is authorised in an increasing number of European and non-European countries. The alleviation of chronic, painful conditions is, since thousands of years, one of the primary reasons for the use of cannabis. Depending on the country, a wide range of medicinal cannabis preparations are available:ranging from defined cultivars of medical cannabis, mainly varying in their THC:CBD ratio, that are inhaled or taken as whole plant extracts,to highly purified single cannabinoids, such as delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD),or mixtures of two enriched extracts, standardised to a 1:1 ratio of THC:CBD (nabiximols). Although conflicting opinions continue to exist, the majority of reviews in the past concluded that medical cannabis and cannabinoids play a significant role in the management of pain. Surprisingly, systematic studies to date do not support an "entourage effect" of the other plant constituents of cannabis (mainly terpenoids) in treatment of chronic pain. An emerging cannabinoid is CBD which is the only cannabinergic medication available at present that does not cause the typical "cannabis high"; it is not a "controlled substance". However, despite years of research, there is either no study or no well-conducted, head-to-head, comparison available between different cannabis cultivars, between pure cannabinoids, and between pure cannabinoids and extracts. It remains unanswered which is the optimal treatment approach.
[Cannabis and cannabinoids for the treatment of acute and chronic pain]. [2022]Since the Act on the medical use of cannabis, at which cannabis-based medicines and cannabinoids became law, there has been an exponential increase in prescriptions for the acquisition of cannabis for medical purposes. The aim of this leading article is to compile and assess the currently available relevant clinical evidence for the use of cannabis and cannabinoids for treatment of acute and chronic pain. Based on the systematic literature review "Cannabis-Potential and risks (CAPRIS)" commissioned by the German Federal Ministry of Health and the recently published recommendations of the European Pain Federation EFIC, this article aims to give an orientation aid for the decision-making process in the clinical routine.
Evidence for using cannabis and cannabinoids to manage pain. [2018]In the past 30 years there has been a rise in anecdotal evidence from patients on the effectiveness of cannabis in pain relief. This has led to an interest in the potential medical use of cannabis and its derivatives (Ware et al, 2003). In the UK this debate has led to expert bodies reviewing the evidence for and against its use in pain management. This article explores this evidence.