drugset / Trial / NCT05344170
Cannabinol Use in Patients With Insomnia Disorder
Phase 1/2
Completed
20 enrolled
Woolcock Institute of Medical Research
University of Sydney · collab
RandomizedCrossoverQuadruple-blindTreatment
Summary
This study aims to investigate the acute effects of cannabinol (CBN) 30 mg and 300 mg, versus placebo, on sleep architecture and next-day functioning in adults aged 25-65 years with chronic insomnia disorder.
Timeline
- Start
- 2022-08-24
- Primary completion
- 2023-08-29
- Completion
- 2023-09-05
Outcome
Missed primary endpoint
paper Cannabinol did not significantly change WASO (300 mg: -6.3 min [95% CI: -18.2, +5.5], p = 0.29 PMID 41698831 ↗
Publications
- Lavender IG, Marshall NS, McCartney D, Cho G, Irwin C, Suraev A, Gordon R, Arnold JC, D'Rozario AL, Gordon CJ, Saini B, Sivam S, Zheng Y, Grunstein RR, Yee BJ, McGregor IS, Hoyos CM. Cannabinol for Acute Treatment of Insomnia Disorder in a Randomized Placebo-Controlled Crossover Trial. J Sleep Res. 2026 Feb 16:e70284. doi: 10.1111/jsr.70284. Online ahead of print.
- Lavender I, McCartney D, Marshall N, Suraev A, Irwin C, D'Rozario AL, Gordon CJ, Saini B, Grunstein RR, Yee B, McGregor I, Hoyos CM. Cannabinol (CBN; 30 and 300 mg) effects on sleep and next-day function in insomnia disorder ('CUPID' study): protocol for a randomised, double-blind, placebo-controlled, cross-over, three-arm, proof-of-concept trial. BMJ Open. 2023 Aug 23;13(8):e071148. doi: 10.1136/bmjopen-2022-071148.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cannabinol | Small molecule | 30 mg | Oral |
| Subject | Cannabinol | Small molecule | 300 mg | Oral |