Targeting Insomnia to Improve Outcomes in Adults With Problematic Cannabis Use

University of Michigan

Status: Enrolling

Conditions: Insomnia

Treatments: Behavioral: Cognitive Behavioral Therapy for insomnia (CBTi-CB-TM); Behavioral: Sleep Hygiene Education (SHE-TM)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05814822

HUM00222302

R01DA057297 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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 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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 2 patient groups

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

Experimental group

Description:

Delivered via telemedicine

Treatment:

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

Sleep Hygiene Education

Active Comparator group

Description:

Delivered via telemedicine

Treatment:

Behavioral: Sleep Hygiene Education (SHE-TM)