Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05344170
Study type Interventional
Source Woolcock Institute of Medical Research
Contact
Status Completed
Phase Phase 1/Phase 2
Start date August 24, 2022
Completion date September 5, 2023

See also
  Status Clinical Trial Phase
Completed NCT00821041 - Internet-based Treatment for Chronic Insomnia Phase 2
Completed NCT03727438 - Provider Supported Self-Help Cognitive Behavioral Therapy for Insomnia (Tele-Self CBTI) N/A
Recruiting NCT03633305 - Optimization of Insomnia Treatment in Primary Care N/A
Completed NCT04616157 - Internet-based Cognitive Behavioral Therapy for Adolescents With Sleep Problems- a Feasibility Trial N/A
Completed NCT03679884 - Study to Assess the Long Term Safety and Tolerability of ACT-541468 (Daridorexant) in Adult and Elderly Subjects Suffering From Difficulties to Sleep Phase 3
Completed NCT02839200 - Efficacy and Safety of ACT-541468 in Adult Subjects With Insomnia Disorder Phase 2
Recruiting NCT04752254 - Investigating Racing Thoughts in Patients With Insomnia Disorder
Completed NCT05558865 - Effectiveness of a Digital Health Application for People With Insomnia Disorder (Somnovia) N/A
Completed NCT05541055 - Digital CBT-I for Insomnia Disorder N/A
Active, not recruiting NCT06393504 - Database Study to Provide Information on Pregnancy and Infant Outcomes Among Women Exposed to QUVIVIQ (Daridorexant)
Completed NCT02841709 - Efficacy and Safety of ACT-541468 in Elderly Subjects With Insomnia Disorder Phase 2
Completed NCT03328585 - Telemedicine vs. In-person Delivery of Cognitive Behavioral Treatment of Insomnia: a Mixed Methods Analysis N/A
Completed NCT02952820 - Long-term Study of Lemborexant in Insomnia Disorder (SUNRISE 2) Phase 3
Recruiting NCT05408078 - Become Your Own SLEEPexpert: a Behavioral Treatment Program for Insomnia in Patients With Psychiatric Disorders N/A
Recruiting NCT05780983 - Sleep Well 24 (SWELL24) Healthy Sleep-Wake Behaviors in Older Adults N/A
Completed NCT03575104 - Study to Assess the Efficacy and Safety of ACT-541468 (Daridorexant) in Adult and Elderly Subjects Suffering From Difficulties to Sleep Phase 3
Not yet recruiting NCT06279286 - Phase Ⅰb/Ⅱ Study of HS-10506 in Chinese Participants With Insomnia Disorder Phase 1/Phase 2
Terminated NCT02571595 - A Sleep Program to Improve Sleep Quality in People With HIV N/A
Completed NCT00984698 - A Trial of Group Psychotherapy for Veterans and Military Personnel With Post Traumatic Stress Disorder (PTSD) N/A
Recruiting NCT05780177 - Brief Behavioral Treatment for Insomnia in Veterans With Posttraumatic Stress Disorder N/A