Targeting Insomnia to Improve Outcomes in Adults With Problematic Cannabis Use
University of Michigan
200 participants
Jun 1, 2023
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria6
- 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 Criteria10
- 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
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Interventions
Participants randomized to CBTi-CB-TM will participate in 6 individual telemedicine sessions delivered by a trained therapist to learn cognitive and behavioral strategies for insomnia.
Participants randomized to SHE-TM will participate in 6 individual telemedicine sessions delivered by a trained therapist to learn sleep hygiene and educational strategies for insomnia.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05814822