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NCT05814822NARecruiting

Targeting Insomnia to Improve Outcomes in Adults With Problematic Cannabis Use

University of Michigan

Start Date

6/1/2023

Completion Date

7/31/2027

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

Age Range: 21 years to No maximum

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

Interventions

BEHAVIORAL

Cognitive Behavioral Therapy for insomnia (CBTi-CB-TM)

BEHAVIORAL

Sleep Hygiene Education (SHE-TM)

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Conditions

Insomnia

Locations

University of Michigan

Ann Arbor, Michigan 48109

United States