Improving sleep in adults with cannabis use issues

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.