Improving sleep in adults with cannabis use issues
Targeting Insomnia to Improve Outcomes in Adults With Problematic Cannabis Use
This study is testing whether a special online therapy for sleep problems can help adults who use cannabis for sleep feel better and sleep more soundly compared to regular sleep education.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | University of Michigan Academic / other |
| Locations | 1 site (Ann Arbor, Michigan) |
| Trial ID | NCT05814822 on ClinicalTrials.gov |
What this trial studies
This study compares the effectiveness of telemedicine-delivered cognitive behavioral therapy for insomnia specifically designed for individuals using cannabis for sleep against telemedicine-delivered sleep hygiene education. It aims to assess improvements in sleep quality, cannabis use, and daytime functioning. Additionally, the study will evaluate the impact of the cognitive behavioral therapy on the body's sleep regulatory system and its correlation with clinical outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults with chronic insomnia who use cannabis at least three times a week to manage their sleep issues.
Not a fit: Patients with other significant sleep disorders or severe mental health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved sleep quality and reduced cannabis dependency for patients struggling with insomnia.
How similar studies have performed: Other studies have shown promising results with cognitive behavioral therapy for insomnia, suggesting potential success for this tailored approach.
Eligibility criteria
Show full inclusion / exclusion 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 (read and spoken) * 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 * Other conditions and situations, medical or otherwise, that preclude meaningful and/or safe participation in CNT/SHE and study procedures
Where this trial is running
Ann Arbor, Michigan
- University of Michigan — Ann Arbor, Michigan, United States (Recruiting)
Study contacts
- Principal investigator: Todd Arnedt, PhD — University of Michigan
- Study coordinator: Libby Cardoni
- Email: mehobson@med.umich.edu
- Phone: 734.764.7175
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.