RECRUITING
ClinicalTrials.gov ID NCT05344170
Sponsor Woolcock Institute of Medical Research
Information provided by Woolcock Institute of Medical Research (Responsible Party)
Last Update Posted 2023-06-23
Study Overview
Brief 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.
Detailed Description:
This is a randomised, double-blind, placebo-controlled, three-arm, crossover, single-centre, proof-of-concept study in twenty participants with chronic insomnia disorder (as per clinician diagnosis and Insomnia Severity Index [ISI] Score ≥15). Across three overnight treatment sessions, participants will receive single dose oral liquid 30 mg cannabinol (CBN), 300 mg CBN, and matched placebo. Participants will undergo overnight sleep assessment using in-laboratory polysomnography (PSG) to examine CBN-related changes to sleep parameters; and various objective and subjective measures of sleep and next-day neurobehavioral function. Each treatment session will be separated by the two-week washout period.
OFFICIAL TITLE
A Randomised, Double-blind, Placebo-controlled, Single-dose, Crossover, Pilot Study Investigating the Effects of Cannabinol (CBN) 30 mg and 300 mg on Sleep Architecture and Next-day Function in Insomnia Disorder
CONDITIONS
Insomnia Disorder
INTERVENTION / TREATMENT
Drug: 30 mg Cannabinol (CBN)
Drug: 300 mg Cannabinol (CBN)
Drug: Placebo
STUDY START (ACTUAL)
2022-08-24
PRIMARY COMPLETION (ESTIMATED)
2023-09-30
STUDY COMPLETION (ESTIMATED)
2023-09-30
ENROLLMENT (ESTIMATED)
20
STUDY TYPE
Interventional
PHASE
Phase 1Phase 2
OTHER STUDY ID NUMBERS
112/2021-08-907
