Low back pain persists as the leading cause for work loss, disability and reduction of quality of life across the world. In 2020, over half a billion prevalent cases of low back pain were recorded. Low back pain is characterized by 3 types of pain occurring simultaneously which are nociceptive (physical damage to muscles or joints), neuropathic (damaged nerves which send wrong signals) and nociplastic (increased nervous system sensitivity without obvious injury). If this pain persists for longer than 3 months, even after the injury or cause has been resolved, it is defined as chronic lower back pain (CLBP).
Chronic lower back pain often causes severe impairments in sleep quality which contributes to degenerative health. It is also often associated with causing impaired physical function. Current treatments for CLBP like nonsteroidal anti-inflammatory drugs (NSAIDs) and opioids provide modest relief but come with high risks.
As CLBP presents a prevalent cause for disability and work loss, there is a necessity to find therapies that negate the risks of NSAIDs and opioids. While there has been a growing interest in cannabis-based therapies, available datasets on cannabis’s efficacy, safety and risk of dependence are homogenous and methodologically limited. However, investigators at the Hannover Medical School in Germany evaluated a cannabis extract named VER-01. New phase 3 data from their clinical trials revealed that standardized cannabis extract delivers meaningful relief for chronic low back pain.
Researchers discovered that VER-01, a full-spectrum Cannabis sativa extract, reduces pain while improving sleep quality and physical function. The study involved over 800 adults with chronic low back pain who found insufficient relief from conventional non-opioid medications. These findings address a critical gap in pain management options for the more than half-billion people worldwide suffering from this debilitating condition.
820 Adults Enrolled in Largest Cannabis Pain Trial to Date
Investigators evaluated VER-01 in more than 820 adults across 66 sites in Germany and Austria for this study. Participants averaged around 52 years old, with 57% being women. All volunteers experienced chronic low back pain lasting longer than 3 months. The research team randomly assigned 394 participants to receive VER-01 and 426 to receive placebo. This 12-week double-blind phase represented the largest and most methodologically sound cannabis pain trial conducted to date. Matthias Karst, MD, PhD, professor of pain medicine at Hannover Medical School, led the investigation.
VER-01 Shows Significant Pain Reduction in Double-Blind Phase
Pain intensity was measured on an 11-point numeric rating scale. VER-01 group participants reported pain reductions of 1.9 points compared to 1.3 points in the placebo group. This 0.6-point difference achieved statistical significance (P < .001). More than half (54%) of VER-01 users achieved at least 30% pain reduction versus 40% of placebo recipients. Participants with neuropathic pain experienced even greater benefits, showing a 1.5-point improvement over placebo. These results demonstrate clinically meaningful pain relief that could transform treatment approaches.
Sleep Quality Improves by 0.7 Points on Standardized Scale
VER-01 participants also reported improvements in their sleep of 0.7 points compared to placebo recipients (P < .001). One of the most severe comorbidities from chronic low back pain is poor sleep. Sleep disruption exacerbates pain perception and reduces quality of life. The cannabis extract addressed this critical aspect of pain management simultaneously with pain reduction. Dr. Karst emphasized that these combined benefits could significantly improve patients’ daily functioning and overall wellbeing.
Physical Function Scores Rise on Roland-Morris Disability Index
Physical function improvements were measured using the Roland-Morris Disability Questionnaire. VER-01 participants showed a mean improvement of 1.1 points over placebo (P < .001). This questionnaire assesses abilities to perform daily activities like climbing stairs, lifting groceries, and bathing. Improved physical function enables patients to engage more fully in rehabilitation exercises and daily life activities. The treatment helped restore mobility that chronic pain had stolen from participants. According to Karst, “These results show the potential to improve patients’ quality of life by helping them sleep better and regain physical activity — both critical for long-term outcomes”.
Six-Month Extension Shows Sustained Benefits Without Dose Escalation
Following the initial 12-week phase, participants entered a 6-month open-label extension period. Nearly three-quarters (73%) of continuing participants achieved at least 30% pain reduction during this phase. More than half (52%) reached the 50% pain reduction threshold. Importantly, researchers observed no dosage increases over time. This lack of tolerance development distinguishes VER-01 from opioid medications which are known to carry high addiction risks. Patients maintained therapeutic benefits without requiring increasingly higher doses. The sustained efficacy suggests it could possibly be viable as a long-term treatment for chronic pain.
Side Effects Predominantly Mild and Transient During Titration
Adverse events occurred more frequently in the VER-01 group (83.3%) than placebo (67.3%). However, most side effects were mild to moderate and transient. Common complaints included dizziness, somnolence, and nausea. These typically appeared during the initial titration period and resolved as participants adjusted to the medication. Only 17% of participants discontinued due to side effects which compares favorably to opioid therapies.
No Evidence of Dependence or Withdrawal in Long-Term Monitoring
Most importantly, researchers found no signs of dependence, abuse, or withdrawal throughout the study. This safety profile addresses major concerns surrounding cannabis-based medicines. The structured withdrawal phase is specifically monitored for these outcomes.
Participants stopping VER-01 did not experience craving or withdrawal symptoms. Dr. Karst highlighted this absence of addictive potential as a key advantage over opioid alternatives. The standardized, low-dose formulation likely contributes to this favorable safety profile. Each dose contained only 2.5 mg THC, far below recreational cannabis levels.
Comparison With Opioids and NSAIDs Highlights Safety Advantages
Current chronic low back pain treatments carry significant limitations. NSAIDs provide only modest relief and pose risks of gastrointestinal bleeding, cardiovascular events, and kidney damage with long-term use. Opioids reduce pain effectively but create high risks for tolerance, dependence, and addiction.
The opioid epidemic demonstrates the devastating consequences of widespread opioid prescribing. VER-01 offers comparable pain relief without these severe safety concerns. While not entirely risk-free, its side effect profile appears more manageable than existing options. This positions cannabis extract as a potentially safer alternative for long-term pain management.
Samer Narouze, MD, PhD, chairman of the Center of Pain Medicine at Western Reserve Hospital, praised the study’s methodological rigor. He noted that the trial addresses 2 imperative unmet needs in terms of cannabis studies. Firstly, effective long-term treatments and secondly, rigorously designed cannabis product studies.
Dr. Narouze highlighted the double-blind, placebo-controlled, multicenter design as a major strength of the study. He acknowledged limitations, including lack of data on prior cannabis use and absence of formal cognitive testing. Jan Vollert, lecturer in neuroscience at the University of Exeter, called the study “excellent” and noted that it provides the high-level evidence the field has long demanded. He emphasized that VER-01 differs fundamentally from smoked cannabis.
Regulatory Approval Process Initiated in Europe and United States
Vertanical, the German company developing VER-01, has submitted applications for regulatory approval. European regulators are reviewing the application, and the company is designing additional studies to meet FDA requirements for U.S. approval. The standardized, pharmaceutical-grade product requires prescription authorization.
This differs from medical cannabis programs that provide raw flower or oils with variable compositions. Standardization ensures consistent dosing and predictable effects. Regulatory approval would establish VER-01 as the first standardized cannabis extract specifically for chronic low back pain. This represents a significant milestone in cannabinoid medicine development.
Neuropathic Pain Subgroups Show Enhanced Response
Post-hoc analyses showed that participants with neuropathic pain responded more robustly to VER-01. These participants experienced 1.5-point greater pain reduction compared to the placebo, double the effect seen in the overall population. Neuropathic pain is often resistant to conventional treatments.
The enhanced response in this subgroup suggests cannabis extracts may target distinct pain mechanisms. THC and other cannabinoids interact with the endocannabinoid system, which modulates pain signaling. This mechanism may prove particularly relevant for nerve-related pain.
Placebo Response Highlights Challenges in Pain Research
The placebo group reported substantial pain reduction (1.3 points), demonstrating the powerful placebo effect in pain studies. Researchers designed the placebo to mimic VER-01’s appearance, taste, and smell using sesame oil and cannabis aroma. This rigorous placebo design strengthens the validity of observed treatment effects.
The 0.6-point difference between groups, while modest, exceeds thresholds for clinical significance in chronic pain trials. Dr. Vollert noted that the open-label extension showed larger effects, illustrating why double-blind designs remain essential. The trial successfully distinguished true drug effects from placebo responses.
Long-Term Safety Monitoring Continues in Extension Studies
Vertanical continues monitoring participants in extended safety studies. These studies track outcomes beyond the initial six-month period. Long-term safety data will inform regulatory decisions and clinical guidelines. Researchers are particularly interested in cognitive effects, liver function, and psychiatric outcomes with prolonged use.
Preliminary data from the extension phases show maintained efficacy without emerging safety signals. However, longer follow-up periods are needed to fully characterize the risk-benefit profile. The company is also exploring VER-01’s potential in other chronic pain conditions, including osteoarthritis and fibromyalgia.
Patient Selection Criteria May Optimize Treatment Success
The trial enrolled participants with inadequate response to non-opioid analgesics. This population represents ideal candidates for novel therapies. Selection criteria excluded individuals with severe psychiatric disorders or substance abuse histories. These exclusions may limit generalizability to broader populations.
Clinicians must carefully screen patients before prescribing VER-01. Factors such as prior cannabis use, psychiatric history, and concomitant medications require consideration. The standardized extract may not produce equivalent effects in recreational cannabis users with existing tolerance. Personalized medicine approaches could identify optimal candidates for this therapy.
Economic Implications Could Reduce Healthcare Burden
Chronic low back pain imposes enormous economic costs through healthcare utilization and lost productivity. Effective treatments that improve function could yield substantial savings. VER-01’s potential to reduce opioid prescriptions may decrease addiction treatment costs. Improved sleep and physical function could enhance work capacity and reduce disability claims. Health economic analyses are needed to quantify these potential benefits.
Public Health Impact Extends Beyond Individual Patients
The opioid epidemic has created urgent demand for non-addictive pain alternatives. VER-01 could shift prescribing patterns away from opioids. This would represent a major public health victory. However, widespread cannabis extract adoption requires physician education and clinical guideline updates. Medical schools currently provide limited cannabinoid medicine training. Professional societies must develop evidence-based recommendations. Patient education about proper use and realistic expectations proves equally important. The therapy’s success depends on appropriate patient selection and monitoring.
Study Limitations Include Lack of Cognitive Testing
Dr. Narouze identified several study limitations. The trial lacked formal cognitive testing, which remains important given THC’s psychoactive properties. Researchers did not collect data on prior cannabis use, which could influence treatment response. The study population was predominantly White European, limiting generalizability to more diverse populations. The 17% discontinuation rate, while acceptable, suggests some patients cannot tolerate side effects. These limitations highlight areas for future research. Additional studies should address these gaps before widespread clinical adoption.
Future Research Directions Include Head-to-Head Comparisons
Future studies should compare VER-01 directly with existing treatments. Head-to-head trials against NSAIDs and opioids would clarify relative efficacy and safety. Comparative effectiveness research would inform clinical decision-making. Studies in specific subpopulations, such as older adults or those with comorbidities, are needed. Research exploring optimal dosing strategies could improve tolerability. Investigation of combination therapies with physical therapy or psychological interventions may enhance outcomes. The robust phase 3 data provides a foundation for this next generation of research.
The VER-01 trial represents a milestone in cannabinoid pain research. It provides rigorous evidence that a standardized cannabis extract can safely reduce chronic low back pain while improving sleep and function. The absence of dependence or withdrawal addresses major safety concerns. While not a panacea, VER-01 offers a viable alternative for patients with limited options. Regulatory approval would establish a new treatment class for chronic pain. Physicians and patients should await formal approval and guidelines before clinical use. The study sets a new standard for cannabis-based medicine research and offers hope to millions living with chronic pain.