Targeting Insomnia to Improve Outcomes in Adults With Problematic Cannabis Use

Launched by UNIVERSITY OF MICHIGAN · Apr 3, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new approach to help adults who have trouble sleeping and also use cannabis to manage their insomnia. The researchers want to find out if a specific type of therapy called cognitive behavioral therapy for insomnia, delivered through telemedicine (meaning you can participate from home), is more effective than general sleep education. The goal is to improve not only sleep quality but also how participants feel and function during the day, while also looking at how this therapy affects the body's natural sleep regulation.

To participate in the trial, you need to be an adult who has chronic insomnia and uses cannabis at least three times a week to help with sleep. You should also have some level of problematic cannabis use, as determined by specific questionnaires. If you’re interested, you’ll need to be able to attend assessments in Ann Arbor and have stable internet access for the telemedicine sessions. This trial is currently recruiting participants and welcomes individuals of all genders. It’s an opportunity to explore a potential solution for better sleep and improved daily functioning.

Gender

ALL

Eligibility criteria

• • INCLUSION CRITERIA
• • 21 years of age and older, the age needed to obtain full legal access to cannabis in Michigan
• • self-reported chronic insomnia (nighttime symptoms of difficulty initiating and/or maintaining sleep and/or early morning awakenings on ≥3 nights for ≥3 months with daytime impairment), consistent with DSM-5 diagnosis of Insomnia Disorder
• • Insomnia Severity Index (ISI) score ≥11, indicative of at least "mild" insomnia
• • a positive urine drug screen (UDS) for cannabis33
• • self-reported use of cannabis at least three times weekly for the past month
• • stable residence (e.g., stable sleep arrangements), consistent access to Wi-Fi, and ability to travel to Ann Arbor for sleep laboratory assessments
• • EXCLUSION CRITERIA
• • individuals who do not understand English
• • individuals judged unable to provide informed consent (e.g., intoxication, mental incompetence)
• • diagnosis or high suspicion of a sleep disorder other than insomnia
• • lifetime diagnosis of psychotic disorder or bipolar disorder; current post-traumatic stress disorder that directly interferes with sleep
• • terminal or progressive physical illness (e.g., cancer) or neurological degenerative disease (e.g., dementia)
• • use of medications known to have initiated their insomnia (e.g., steroids)
• • previous receipt of CBTi
• • self-reported pregnancy
• • self-reported regular work schedule of rotating or night (3rd) shift work.