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Cannabis Sativa Flower

Recent clinical trials are investigating the potential of Cannabis Sativa Flower as a treatment for diabetic peripheral neuropathic pain (DPNP). This study focuses on using a medical cannabis aerosol delivered through the Syqe Inhaler, a fixed-dose device. The research aims to evaluate the efficacy and safety of different doses of THC (tetrahydrocannabinol) compared to a placebo in managing pain intensity for patients with DPNP.

Table of Contents

What is Cannabis Sativa Flower?

Cannabis Sativa Flower, also known as Cannabis flower or Cannabis sativa flos, is a medicinal plant product being studied for its potential therapeutic benefits[1]. The main active ingredient in this treatment is Δ9-tetrahydrocannabinol (THC), which is one of the primary compounds found in cannabis plants known for its medicinal properties.

Medical Condition Treated

The primary focus of the current research is on treating Diabetic Peripheral Neuropathic Pain (DPNP)[1]. This is a type of nerve pain that affects people with diabetes. It typically causes a burning, tingling, or shooting pain in the feet and legs, and sometimes in the hands and arms. This pain is a result of nerve damage caused by prolonged high blood sugar levels in diabetic patients.

How It’s Administered

The Cannabis Sativa Flower is administered as an aerosol using a special device called the Syqe Inhaler[1]. This is a fixed-dose inhaler system that allows for precise dosing of the medication. The system consists of three parts:

  • The Syqe Fixed-dose Inhaler
  • Syqe Cartridge (containing the medication)
  • Syqe Mouthpiece

This method of administration allows for quick absorption of the medication through the lungs, potentially providing faster relief compared to other forms of cannabis-based treatments.

Dosage and Treatment

In the ongoing clinical trial, researchers are testing three different doses of THC: 0.25 mg, 0.5 mg, and 1.0 mg[1]. These doses are administered three times a day (TID). The maximum daily dose being tested is 3 mg, and the treatment period lasts for about 15 weeks.

Efficacy and Benefits

The main goal of this treatment is to reduce pain intensity in patients with DPNP. Researchers are evaluating its effects on:

  • Average, worst, and least pain intensity
  • Pain characteristics and severity
  • Quality of life
  • Sleep disturbances related to pain

The study aims to determine if this treatment can provide significant pain relief compared to a placebo when added to standard care for DPNP[1].

Safety and Side Effects

As with any medication, safety is a primary concern. The ongoing study is closely monitoring for any side effects or adverse reactions. Some areas being watched include:

  • General adverse events and their severity
  • Effects on mental health (using tools like the Columbia-Suicide Severity Rating Scale)
  • Impacts on lung function (through spirometry tests)
  • Effects on heart function (via electrocardiogram)
  • Changes in blood and urine tests

It’s important to note that this treatment may affect your ability to drive or operate heavy machinery, and patients in the study are advised against these activities during the treatment period[1].

Who Can Use This Treatment

This treatment is still in the research phase and not yet available for general use. In the current study, eligible participants are:

  • Adults aged 18 to 75 years
  • Diagnosed with diabetes (Type I or II) with stable blood sugar control
  • Experiencing DPNP for at least 6 months
  • Already on standard care for DPNP (such as duloxetine, gabapentin, or pregabalin)
  • Not current users of cannabis products

There are several exclusion criteria, including certain medical conditions, medications, and lifestyle factors. Always consult with a healthcare provider to determine if a treatment is appropriate for you[1].

Ongoing Research

This treatment is currently being studied in a clinical trial. The research aims to determine its effectiveness, optimal dosage, and safety profile. The study is also looking at how the body processes the medication (pharmacokinetics) and its effects on various aspects of patients’ lives, including sleep quality and overall well-being[1].

It’s important to remember that while this treatment shows promise, it is still in the research phase. More studies will be needed to fully understand its benefits and risks before it can be considered for wider use in treating DPNP.

Aspect Details
Study Design Double-blind, randomized, placebo-controlled, 4-arm parallel-group
Condition Diabetic Peripheral Neuropathic Pain (DPNP)
Intervention Cannabis Sativa L. ‘Afina’ inflorescence aerosol via Syqe Inhaler
Dosages 0 mg (placebo), 0.25 mg, 0.5 mg, 1.0 mg of Δ9-THC
Administration Inhaled three times daily (TID)
Duration 19 weeks (14 days screening, 15 weeks treatment, 4 weeks follow-up)
Primary Endpoint Change in weekly-mean 24-hour average pain score at Week 15
Key Inclusion Criteria Ages 18-75, diagnosed DPNP, stable diabetes treatment, pain intensity ≥4 and ≤9 on NRS
Key Exclusion Criteria Recent cannabis use, substance abuse, significant uncontrolled diseases, abnormal liver/kidney function

FAQ

  • What is the main purpose of this clinical trial? The main purpose of this clinical trial is to evaluate the effectiveness of medical cannabis aerosol containing different doses of THC (0.25, 0.5, and 1.0 mg) compared to a placebo in reducing pain intensity for patients with diabetic peripheral neuropathic pain (DPNP) after 15 weeks of treatment.
  • How is the cannabis administered in this study? The cannabis is administered as an aerosol using the Syqe Inhaler, a fixed-dose device. Patients inhale the medication three times a day (TID) throughout the study period.
  • Who can participate in this clinical trial? Participants must be between 18 and 75 years old, have a confirmed diagnosis of diabetes mellitus type I or II, and have been experiencing daily symmetrical foot pain due to peripheral neuropathy for at least 6 months. They must also be currently treated with standard care for DPNP and not have used cannabis products within 3 months of the screening visit.
  • What are some of the exclusion criteria for this study? Some exclusion criteria include a history of drug or alcohol abuse within 12 months prior to screening, seizure disorders, significant uncontrolled diseases, abnormal liver or kidney function, and certain mental health conditions. Pregnant or breastfeeding women are also excluded.
  • How long does the clinical trial last? The clinical trial lasts approximately 19 weeks in total. This includes a screening period of up to 14 days, a 15-week treatment period (3 weeks of dose up-titration and 12 weeks of maintenance), and a 4-week safety follow-up period.

Ongoing Clinical Trials on Cannabis Sativa Flower

  • Study on Medical Cannabis Aerosol for Treating Diabetic Nerve Pain in Patients Using Syqe Inhaler

    Not recruiting

    2 1
    Investigated drugs:
    Czechia Germany Poland

Glossary

  • Diabetic Peripheral Neuropathic Pain (DPNP): A type of nerve pain caused by diabetes that typically affects the feet and legs, resulting in numbness, tingling, or burning sensations.
  • THC (Δ9-tetrahydrocannabinol): The main psychoactive compound in cannabis that is responsible for many of its effects, including pain relief.
  • Syqe Inhaler: A medical device used in this study to deliver precise doses of cannabis aerosol to patients.
  • Placebo: A substance with no active medical ingredients, used as a control in clinical trials to test the effectiveness of new treatments.
  • Efficacy: The ability of a treatment to produce the desired beneficial effect.
  • Pharmacokinetics (PK): The study of how a drug moves through the body, including its absorption, distribution, metabolism, and excretion.
  • Numeric Rating Scale (NRS): A pain assessment tool where patients rate their pain intensity on a scale from 0 to 10.
  • Standard of Care: The currently accepted treatment methods for a specific condition, in this case, for diabetic peripheral neuropathic pain.
  • Adverse Events (AEs): Any unfavorable or unintended sign, symptom, or disease that occurs during a clinical trial, whether or not it is related to the treatment being studied.
  • Up-titration: The process of gradually increasing the dose of a medication to find the optimal effective dose with minimal side effects.

References

  1. http://clinicaltrials.eu/trial/study-on-medical-cannabis-aerosol-for-treating-diabetic-nerve-pain-in-patients-using-syqe-inhaler/