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.

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

De-identified participant data will be uploaded biannually into the NIMH National Data Archive. This archive is accessible only by other researchers who are members and agree to data access protocols. All participant identifiers are stripped and data are uploaded using a Global Unique Identifier. Data to be shared include responses to self-report measures and polysomnography. In accordance with ClinicalTrials.gov guidelines, results will be shared here no later than one year after primary study completion.

Data will be available starting one year following the primary completion date of the study. There is no end date for data accessibility on the NDA.

Data are available only for research purposes to users who complete the NDA Data Use Certification. Certifications are accepted only from researchers who are sponsored by an institution registered in the NIH eRA Commons. The application to access data must include a specific reason for access related to scientific investigation, scholarship, or other research.