Targeting Insomnia to Improve Outcomes in Adults With Problematic Cannabis Use
NCT ID: NCT05814822
Last Updated: 2025-08-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
200 participants
INTERVENTIONAL
2023-06-01
2027-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
DOUBLE
Study Groups
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Cognitive Behavioral Therapy for insomnia (CBTi-CB-TM)
Delivered via telemedicine
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.
Sleep Hygiene Education
Delivered via telemedicine
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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 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
21 Years
ALL
No
Sponsors
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National Institute on Drug Abuse (NIDA)
NIH
University of Michigan
OTHER
Responsible Party
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J. Todd Arnedt
Professor of Psychiatry, Professor of Neurology
Principal Investigators
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Todd Arnedt, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Locations
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University of Michigan
Ann Arbor, Michigan, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HUM00222302
Identifier Type: -
Identifier Source: org_study_id
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