Randomized withdrawal study of nabiximols in MS spasticity

Introduction and clinical context

The study Randomized withdrawal study of nabiximols in MS spasticity (PubMed · 2011) is part of the scientific research on the use of cannabinoids in multiple sclerosis.

In multiple sclerosis (MS), an autoimmune disease of the central nervous system, spasticity — muscle stiffness and spasms — is a frequent, disabling symptom. Nabiximols (Sativex), an oromucosal spray with an approximately 1:1 ratio of THC to CBD, is the most studied cannabinoid in this context, with clinical trials indicating a reduction in spasticity as an adjuvant therapy when conventional treatments are not enough. Cannabinoids are also assessed for the central neuropathic pain associated with MS.

Understanding what science shows about the use of cannabinoids in multiple sclerosis helps patients and healthcare professionals make safer, well-founded decisions, based on evidence rather than common sense.

Methodology and findings

This clinical trial was conducted in a controlled manner, comparing the treatment with a reference group. Confirms the benefit of nabiximols as an adjuvant therapy in spasticity. The blinded, controlled design reduces bias and increases the reliability of the finding. Results from controlled trials like this are especially valuable for guiding therapeutic decisions.

Mechanism of action and safety

Nabiximols combines THC and CBD in an approximately 1:1 ratio and acts on CB1/CB2 receptors to reduce the neuronal hyperexcitability associated with spasticity; as an oromucosal spray, it allows fine dose titration. Adverse effects include dizziness, fatigue and mild psychoactive effects linked to THC. Caution is recommended in patients with a psychiatric history, and attention to interactions with CNS depressants. Gradual introduction and periodic reassessment of the response — keeping the lowest effective dose — are the basis of safe use in this neurological population.

Regulation in Brazil (Anvisa)

In Brazil, access to cannabis products is regulated by Anvisa — mainly through RDC 660/2022 (patient import with a medical prescription) and the new manufacturing and import framework, RDC 1,015/2026. Any therapeutic use must start from an individualized medical assessment and prescription. This content is informative and scientific and does not replace the guidance of a healthcare professional.

This is informative content produced by Brazcann; for the full methodology and detailed results, consult the original publication (PubMed · 2011). Access to cannabis treatments must always occur through the regulated pathway, with a prescription and medical follow-up.

Frequently asked questions

Does cannabis help in multiple sclerosis?

Nabiximols was studied to reduce spasticity as an adjuvant therapy; use is prescribed by a doctor.

What is spasticity?

It is the muscle stiffness and involuntary spasms common in MS, which affect mobility.