Dronabinol for Chronic Low Back Pain

(DARP Trial)

Recruiting at 1 trial location

Overseen By Adetola O Vaughan, MA

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Christopher D. Verrico

Must not be taking: Cannabinoids, Antiepileptics, Benzodiazepines, others

Disqualifiers: Cannabis use, Psychiatric illness, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

75 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether Dronabinol, a synthetic form of THC, can safely and effectively help individuals with chronic low back pain. Researchers aim to determine if it can reduce pain for those who have experienced back pain for at least three months and feel it on most days. Participants will be divided into two groups: one receiving the drug and the other a placebo (a dummy pill), to compare results after eight weeks. Individuals who have managed their back pain consistently for three months or more and are not currently using cannabis products might be suitable for this study. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial requires you to stop using cannabis, marijuana, and any cannabinoids, including over-the-counter CBD products. You also cannot use certain medications like antiepileptic drugs, barbiturates, benzodiazepines, and some antidepressants. If you're on a stable pain treatment for at least 3 months, you can continue with that.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that dronabinol, a synthetic version of THC, has been studied for its impact on pain. One study found that cannabis, the source of dronabinol, reduced back pain with generally manageable side effects. However, little is known about its long-term effects. Another study discovered that THC edibles temporarily reduced pain in individuals with chronic low back pain.

Overall, dronabinol appears to be fairly well-tolerated, but more detailed safety information is needed. This study serves as an important step in determining whether dronabinol is safe enough for larger future studies. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for chronic low back pain?

Unlike the standard of care for chronic low back pain, which often includes NSAIDs, opioids, and physical therapy, dronabinol is derived from cannabis and works by interacting with the body's endocannabinoid system. This unique mechanism of action could offer pain relief by targeting cannabinoid receptors, potentially reducing inflammation and pain perception. Researchers are excited about dronabinol because it may provide an alternative to opioids, with a different side effect profile, possibly leading to safer long-term use for managing chronic pain.

What evidence suggests that dronabinol might be an effective treatment for chronic low back pain?

Research has shown that substances like dronabinol, derived from cannabis, might help reduce long-lasting pain. In several studies, participants using cannabis-based treatments reported less pain than those who did not. For instance, one study found a 30% reduction in back pain among cannabis users. Another review indicated that these substances are more effective for ongoing pain than for short-term pain. This trial will evaluate dronabinol as a treatment for chronic low back pain, suggesting its potential promise for this condition. ^{1 2 3 6 7}

Who Is on the Research Team?

Christopher D Verrico, phD

Principal Investigator

Baylor College of Medicine

Are You a Good Fit for This Trial?

This trial is for adults with chronic low back pain or a back injury. Participants must be willing to take oral medication and be available for the full 8-week study period. People who are pregnant, breastfeeding, have certain mental health conditions, or use substances that could interact with THC are not eligible.

Inclusion Criteria

I am willing and able to follow the study rules and attend all required visits.

My pain management treatment has been the same for the last 3 months.

For females of reproductive potential: currently practicing an effective form of two types of birth control for at least 1 month prior to screening and agrees to use such a method during study participation and for an additional 4 weeks after the end of study medication administration unless she is surgically sterile, partner is surgically sterile, or she is postmenopausal

Exclusion Criteria

Systolic blood pressure > 140 mm Hg, or diastolic blood pressure > 90 mm Hg

I currently use cannabis or CBD products and do not want to stop.

Pregnancy, plans to become pregnant, or lactation

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive dronabinol or placebo capsules, up to 15 mg, twice per day for 8 weeks

8 weeks

Regular visits for monitoring and assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Dronabinol

Trial Overview

The trial is testing Dronabinol (synthetic THC) against a placebo to see if it can help reduce chronic lower back pain. Participants will either receive up to 30 mg/day of Dronabinol or a placebo over an 8-week period in a blinded study where neither they nor the investigators know who's receiving the actual drug.

How Is the Trial Designed?

Group I: Drug: Dronabinol Experimental Treatment 1 Intervention

Dronabinol capsules, over-encapsulated with filler to match the appearance of the placebo capsule, up to 15 mg, twice per day for 8 weeks.

Group II: Placebo Placebo Group 1 Intervention

Capsules with placebo (i.e., cellulose filler), twice per day for 8 weeks.

Who Is Running the Clinical Trial?

Christopher D. Verrico

Lead Sponsor

Trials

2

Recruited

120+

Published Research Related to This Trial

A study of 26 prescribers across France revealed that dronabinol is primarily prescribed for chronic pain related to multiple sclerosis (49.7%) and central neuropathic pain (36.6%), with an average treatment duration of 1 month to 6 years.

About 59% of patients reported a significant reduction in pain (30 to 50%), indicating that dronabinol may be an effective option for managing refractory chronic pain, but further research is needed to optimize its use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dronabinol use in France between 2004 and 2017. Lejczak, S., Rousselot, H., Di Patrizio, P., et al.[2020]

In a study of 1,145 patients with refractory chronic pain, adding Δ9-tetrahydrocannabinol (dronabinol) to their treatment significantly reduced average pain intensity from 46.3 to 26.8 mm on a visual analog scale over 12 weeks.

Dronabinol was well tolerated, with 46.8% of patients reporting mild drug-related adverse events, and many patients were able to reduce or stop other pain medications during the treatment period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness and Tolerability of Dronabinol Use in Patients with Chronic Pain: A Retrospective Analysis of 12-Week Open-Label Real-World Data Provided by the German Pain e-Registry. Ueberall, MA., Horlemann, J., Schuermann, N., et al.[2022]

Current evidence does not support the effectiveness of cannabidiol (CBD) for treating acute low back pain, as a clinical trial showed no significant difference compared to placebo.

While there are indications that CBD may help relieve chronic low back pain, the overall evidence is still weak, highlighting the need for more rigorous randomized controlled trials to confirm its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can cannabidiol (CBD) help with low back pain? Kulesza, B., Mazurek, M., Kurzepa, J.[2023]

In a clinical trial involving 240 multiple sclerosis patients over 16 weeks, dronabinol reduced neuropathic pain intensity by 1.92 points, similar to the 1.81 points reduction seen with placebo, indicating no significant difference in pain relief between the two treatments.

Dronabinol was found to be a safe long-term treatment option, with a higher rate of adverse reactions compared to placebo (50% vs. 25.9%), but these reactions decreased to 26% during extended use, and there were no significant signs of drug abuse or dependency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dronabinol Is a Safe Long-Term Treatment Option for Neuropathic Pain Patients. Schimrigk, S., Marziniak, M., Neubauer, C., et al.[2018]

Dronabinol (Δ9-THC) shows potential as an analgesic for chronic pain, but its effectiveness varies due to different pain mechanisms, highlighting the need for a deeper understanding of how it works in the body.

The review emphasizes the importance of developing objective biomarkers to assess the effects of dronabinol on pain, which could help identify which patients are likely to benefit from this treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dronabinol and chronic pain: importance of mechanistic considerations. de Vries, M., van Rijckevorsel, DC., Wilder-Smith, OH., et al.[2018]

In a study of 2,112 adult patients with chronic pain, 92.5% reported improvement in their primary symptoms after using cannabis-based oral formulations, indicating high efficacy as an adjuvant treatment.

The majority of patients experienced minimal side effects, with 71.7% reporting none, and the most common mild side effects, such as somnolence and dizziness, tended to decrease over time, suggesting that these formulations are safe for chronic pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sex-Dependent Prescription Patterns and Clinical Outcomes Associated With the Use of Two Oral Cannabis Formulations in the Multimodal Management of Chronic Pain Patients in Colombia. Moreno-Sanz, G., Madiedo, A., Hernandez, P., et al.[2022]

In a study involving 20 chronic pain patients with fibromyalgia, inhaled cannabis did not show significant analgesic effects compared to placebo, although the Bediol variety led to a 30% decrease in pain scores for some patients.

Cannabis containing THC increased pressure pain thresholds, but the presence of CBD appeared to reduce the overall pain-relieving effects of THC, highlighting complex interactions between these cannabinoids.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An experimental randomized study on the analgesic effects of pharmaceutical-grade cannabis in chronic pain patients with fibromyalgia. van de Donk, T., Niesters, M., Kowal, MA., et al.[2022]

In a study involving 30 patients on opioids for chronic pain, dronabinol (synthetic THC) was found to significantly reduce pain intensity and increase treatment satisfaction compared to a placebo, indicating its potential as an effective adjuvant treatment.

The extended Phase II trial showed that titrated doses of dronabinol provided significant pain relief and reduced pain bothersomeness, although side effects were dose-related, suggesting careful monitoring is needed when using this medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of dronabinol as an adjuvant treatment for chronic pain patients on opioid therapy. Narang, S., Gibson, D., Wasan, AD., et al.[2013]

In a study of 19 patients with refractory neuropathic pain, 75% of those who continued dronabinol treatment for over 3 months reported an improvement in their health, suggesting its potential efficacy as a pain management option.

However, 74% of patients experienced at least one adverse event, with six needing to discontinue treatment, highlighting the importance of careful monitoring and evaluation of the drug's safety and benefit-risk balance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Use of dronabinol in the treatment of resistant neuropathic pain: Feedback from patients followed in a multidisciplinary pain center]. Richet, E., Ferret, L., Gaboriau, L., et al.[2023]

In a meta-analysis of 16 trials, nabilone was associated with significantly higher rates of drowsiness, dizziness, and dry mouth compared to placebo, indicating a notable risk of these side effects.

Dronabinol also showed increased occurrences of dry mouth, dizziness, and headache compared to placebo, but the overall severity of adverse events was generally mild-to-moderate, suggesting that the benefits may outweigh the risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Safety of Dronabinol and Nabilone: A Systematic Review and Meta-Analysis of Clinical Trials. Bajtel, Á., Kiss, T., Tóth, B., et al.[2022]

A systematic review of 43 randomized controlled trials involving 4436 participants found that current cannabinoid trials for chronic pain often fail to meet key safety reporting standards, with an average of 3 to 4 CONSORT guidelines not being followed.

Many trials lacked adequate assessment and reporting of adverse events, with 17 trials not detailing their methods for assessing adverse events and 14 trials failing to report serious adverse events, highlighting a significant gap in safety evaluation in cannabinoid research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence to Consolidated Standards of Reporting Trials (CONSORT) Guidelines for Reporting Safety Outcomes in Trials of Medical Cannabis and Cannabis-based Medicines for Chronic Noncancer Pain: A Systematic Review. Mohiuddin, MM., Mizubuti, GB., Haroutounian, S., et al.[2021]

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Dronabinol as an Adjunct for Reducing Pain

Collectively, these data suggest that cannabinoids may be more effective for chronic rather than acute pain conditions. However, there have been few randomized, ...

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pmc.ncbi.nlm.nih.gov/articles/PMC8907633/

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npr.org/sections/shots-health-news/2025/10/20/nx-s1-5574424/cannabis-marijuana-back-pain

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