Controlled clinical trial of cannabidiol in Huntington's disease.

Consroe et al. ·Pharmacology Biochemistry and Behavior

No benefit demonstrated GRADE Moderate 316 citations

Samplen = 15 Pat.

Duration6 weeks

ControlPlacebo, 6 weeks

EndpointChorea severity

Blindingdoppelblind

DesignRCT (cross-over)

Key finding

CBD was neither symptomatically effective nor toxic compared to placebo in Huntington's patients.

Summary

Double-blind randomized cross-over trial n=15 HD patients; oral CBD ~700 mg/day for 6 weeks vs. placebo; no significant difference (p>0,05) in chorea severity, clinical laboratory values or Cannabis Side Effects Inventory; CBD safe and non-toxic at high dosage over 6 weeks.

PopulationNeuroleptic-free patients with Huntington's disease, n=15

InterventionOral cannabidiol (CBD) 10 mg/kg/day, 6 weeks

ControlPlacebo (sesame oil), 6 weeks

OutcomeNo significant differences between CBD and placebo regarding chorea severity or other outcome variables (p>0,05)

Confidence in the evidence

Moderate

The third of four GRADE levels, the effect estimate is probably reliable.

Downgraded for

Imprecision

Quality profile

Sample size ★★★★★

Blinding Double-blind

Effect size No benefit

Citations / year ★★★★★

Authors

Consroe P, Laguna J, Allender J, Snider S, Stern L, Sandyk R, Kennedy K, Schram K.

DOI 10.1016/0091-3057(91)90386-g↗

Design: RCT (cross-over)

Abstract

Based on encouraging preliminary findings, cannabidiol (CBD), a major nonpsychotropic constituent of Cannabis, was evaluated for symptomatic efficacy and safety in 15 neuroleptic-free patients with Huntington's Disease (HD). The effects of oral CBD (10 mg/kg/day for 6 weeks) and placebo (sesame oil for 6 weeks) were ascertained weekly under a double-blind, randomized cross-over design. A comparison of the effects of CBD and placebo on chorea severity and other therapeutic outcome variables, and on a Cannabis side effect inventory, clinical lab tests and other safety outcome variables, indicated no significant (p greater than 0.05) or clinically important differences. Correspondingly, plasma levels of CBD were assayed by GC/MS, and the weekly levels (mean range of 5.9 to 11.2 ng/ml) did not differ significantly over the 6 weeks of CBD administration. In summary, CBD, at an average daily dose of about 700 mg/day for 6 weeks, was neither symptomatically effective nor toxic, relative to placebo, in neuroleptic-free patients with HD.

The impediment to action advances action. — Marcus Aurelius