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Targeting Insomnia to Improve Outcomes in Adults With Problematic Cannabis Use

This study is looking at ways to help adults who use cannabis and also have chronic insomnia (trouble sleeping). Researchers want to see if two different types of telemedicine (online) therapy can improve sleep, reduce cannabis use, and improve daily functioning. You would receive either Cognitive Behavioral Therapy for insomnia (CBTi-CB-TM), which teaches strategies for better sleep, or Sleep Hygiene Education (SHE-TM), which focuses on good sleep habits. To join, you need to be 21 or older, have chronic insomnia, and an Insomnia Severity Index (ISI) score of 11 or higher. The study will measure how often you use cannabis, your insomnia severity, and your mental well-being over about 6 months after the intervention. The study is currently unclear on its recruitment status and plans to enroll 200 participants.

Study design
This interventional study plans to enroll 200 participants. It compares two different behavioral therapies delivered via telemedicine.
What's involved
Participants will take part in 6 individual telemedicine sessions with a trained therapist. The study will measure outcomes for up to 6 months after these sessions.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 6 months after the intervention, which is approximately 32 weeks.

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NCT05814822

Targeting Insomnia to Improve Outcomes in Adults With Problematic Cannabis Use

Recruiting
NAAges 21+InterventionalHealth services
University of Michigan
~200 participants
Updated 2026-05-22 on ClinicalTrials.gov
What's tested:Cognitive Behavioral Therapy for insomnia (CBTi-CB-TM)Sleep Hygiene Education (SHE-TM)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Frequency of cannabis use as measured by the Timeline Followback (TLFB)
Measured over Up to 6 months after intervention, approximately 32 weeks
+2 more outcomes measured

Conditions

Insomnia

Explore related trials

Cannabis misuseInsomnia

Where it's being run

1 sites across 1 states
Michigan1

Study leadership

  • Todd Arnedt, PhD · PRINCIPAL_INVESTIGATOR · University of Michigan

Who to contact

Libby Cardoni
[email protected]
734.764.7175
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Frequency of cannabis use as measured by the Timeline Followback (TLFB)Up to 6 months after intervention, approximately 32 weeks

    Changes in frequency of cannabis use will be evaluated over the past 30 days using the Timeline Followback, widely considered the "gold standard" tool for assessing daily substance use. It will be used to measure the frequency of use of THC-containing cannabis products used across all modalities guided by pictorial aids. Participants are asked to specify motivations behind cannabis use, including recreation, medicinal use, sleep aid, or other reasons. We will collect data on alcohol and other substance use during the interview. The primary outcome is frequency of cannabis use per day across all modalities. Participants obtain cannabis from a variety of sources and thus dose assessments using retrospective recall would not be reliable. We therefore chose frequency as our primary outcome, which is also recommended by expert consensus.

  • Insomnia Severity Index (ISI) total score measured by the Insomnia Severity Index (ISI)Up to 6 months after intervention, approximately 32 weeks

    Changes in insomnia severity from baseline to post-treatment is assessed with the 7-item Insomnia Severity Index (ISI), a self-administered assessment of global insomnia severity over the past 2 weeks that ranges in score from 0 to 28, with higher scores indicating more severe insomnia symptoms (0-7 no clinical insomnia, 8-14 mild insomnia severity, 15-22 moderate insomnia severity, 23-28 severe insomnia severity). The primary outcome is ISI total score.

  • Mental Composite Score (MCS-12) as assessed by the 12-item Short-Form Health Survey (SF-12)Up to 6 months after intervention, approximately 32 weeks

    The 12-item Short-Form Health Survey (SF-12) is a short-form quality of life measure derived from the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36). The primary outcome is the Mental Component Summary Score (MCS-12), which ranges from 0-100, with higher scores indicating better health