Targeting Insomnia to Improve Outcomes in Adults With Problematic Cannabis Use
Recruiting
Who can join
Ages 21 and older · All sexes
Full 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 (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
About the study
This study will compare the efficacy of telemedicine-delivered cognitive behavioral therapy for insomnia tailored for people using cannabis for sleep (CBTi-CB-TM) to telemedicine-delivered sleep hygiene education (SHE-TM) on sleep, cannabis use, and daytime functioning. We will also evaluate the effects of CBTi-CB-TM on fundamental sleep regulatory system - homeostatic sleep drive - and its association with clinical outcomes.
What is being tested
- Cognitive Behavioral Therapy for insomnia (CBTi-CB-TM) (behavioral)
- Sleep Hygiene Education (SHE-TM) (behavioral)
Sponsor: University of Michigan · Participants: 200 · Started: Jun 1, 2023
Contact the study team
- Libby Cardoni · Phone: 734.764.7175
Official record on ClinicalTrials.gov — NCT05814822
Locations in the U.S.
| Michigan | University of Michigan, Ann Arbor |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.