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Recruiting NCT05814822

Targeting Insomnia to Improve Outcomes in Adults With Problematic Cannabis Use

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Trial Parameters

Condition Insomnia
Sponsor University of Michigan
Study Type INTERVENTIONAL
Phase N/A
Enrollment 200
Sex ALL
Min Age 21 Years
Max Age N/A
Start Date 2023-06-01
Completion 2027-08-31
Interventions
Cognitive Behavioral Therapy for insomnia (CBTi-CB-TM)Sleep Hygiene Education (SHE-TM)

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Brief 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 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 psychoti

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