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RECRUITINGINTERVENTIONAL

Targeting Insomnia to Improve Outcomes in Adults With Problematic Cannabis Use

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

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 willing to sign a consent form (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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

BEHAVIORAL

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

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.

BEHAVIORAL

Sleep Hygiene Education (SHE-TM)

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)

University of Michigan
Ann Arbor, Michigan, United States