Nabiximols Did Not Reduce Spasticity After Stroke but Appeared Safe for Heart Patients

In a double-blind RCT, nabiximols (Sativex) did not reduce spasticity in stroke patients compared to placebo, but importantly showed no cardiovascular safety concerns in this high-risk population.

Marinelli, Lucio et al.·Frontiers in neurology·2022·Moderate EvidenceRandomized Controlled Trial
RTHC-04043Randomized Controlled TrialModerate Evidence2022RETHINKTHC RESEARCH DATABASErethinkthc.com/research

Quick Facts

Study Type
Randomized Controlled Trial
Evidence
Moderate Evidence
Sample
N=41

What This Study Found

Among 34 stroke patients, nabiximols did not improve spasticity on the primary or secondary endpoints compared to placebo. However, no cardiovascular adverse events occurred, suggesting cannabis-based treatments may be safe in stroke patients despite theoretical cardiovascular risks.

Key Numbers

41 enrolled, 34 completed; 2 serious adverse events (none cardiovascular); no primary or secondary efficacy endpoints met; crossover design with 1-month phases

How They Did This

Double-blind, randomized, placebo-controlled crossover trial. 41 patients entered, 34 completed. Patients received nabiximols oromucosal spray or placebo for 1 month each, with cardiovascular monitoring throughout.

Why This Research Matters

Nabiximols is approved for MS spasticity but not stroke spasticity. While this trial found no efficacy, the cardiovascular safety finding is significant because stroke patients are typically excluded from cannabis studies due to heart risk concerns.

The Bigger Picture

Spasticity mechanisms differ between MS and stroke, which may explain the null finding. The safety data, however, opens the door for further investigation of cannabinoids in stroke patients for other indications.

What This Study Doesn't Tell Us

Small sample size may have been underpowered to detect effects. Patients had relatively low baseline pain and spasticity levels, which may have limited room for improvement.

Questions This Raises

  • ?Would nabiximols work for stroke patients with higher baseline spasticity?
  • ?Do different spasticity mechanisms between MS and stroke require different cannabinoid approaches?

Trust & Context

Key Stat:
No cardiovascular adverse events in stroke patients
Evidence Grade:
Well-designed double-blind crossover RCT, but small sample and potentially underpowered.
Study Age:
Published in 2022
Original Title:
Cannabinoid Effect and Safety in Spasticity Following Stroke: A Double-Blind Randomized Placebo-Controlled Study.
Published In:
Frontiers in neurology, 13, 892165 (2022)
Database ID:
RTHC-04043

Evidence Hierarchy

Meta-Analysis / Systematic Review
Randomized Controlled TrialGold standard for testing treatments
This study
Cohort / Case-Control
Cross-Sectional / Observational
Case Report / Animal Study

Participants are randomly assigned to treatment or placebo groups to test cause and effect.

What do these levels mean? →

Frequently Asked Questions

Does nabiximols help with spasticity after stroke?

This RCT found no benefit of nabiximols over placebo for post-stroke spasticity. The authors suggest this may be because spasticity mechanisms differ between stroke and multiple sclerosis, where nabiximols is approved.

Is cannabis safe for stroke patients?

Despite concerns about cardiovascular risks, this study found no cardiovascular adverse events in stroke patients using nabiximols, suggesting it may be safe for this population. This is important because stroke patients are usually excluded from cannabis research.

Read More on RethinkTHC

Cite This Study

RTHC-04043·https://rethinkthc.com/research/RTHC-04043

APA

Marinelli, Lucio; Puce, Luca; Mori, Laura; Leandri, Massimo; Rosa, Gian Marco; Currà, Antonio; Fattapposta, Francesco; Trompetto, Carlo. (2022). Cannabinoid Effect and Safety in Spasticity Following Stroke: A Double-Blind Randomized Placebo-Controlled Study.. Frontiers in neurology, 13, 892165. https://doi.org/10.3389/fneur.2022.892165

MLA

Marinelli, Lucio, et al. "Cannabinoid Effect and Safety in Spasticity Following Stroke: A Double-Blind Randomized Placebo-Controlled Study.." Frontiers in neurology, 2022. https://doi.org/10.3389/fneur.2022.892165

RethinkTHC

RethinkTHC Research Database. "Cannabinoid Effect and Safety in Spasticity Following Stroke..." RTHC-04043. Retrieved from https://rethinkthc.com/research/marinelli-2022-cannabinoid-effect-and-safety

Access the Original Study

Study data sourced from PubMed, a service of the U.S. National Library of Medicine, National Institutes of Health.

This study breakdown was produced by the RethinkTHC research team. We analyze and report published research findings without making health recommendations. All interpretations are based solely on the published abstract and study data.