Early access
Sign in
Taking people in United StatesNo phase

Remote sleep therapy for insomnia in adults who use cannabis

Tests remote sleep therapy for insomnia in adults using cannabis.

Key facts

Who runs it
University of Michigan
Where
Ann Arbor, United StatesSee the site
Trial code
Registry title
Targeting Insomnia to Improve Outcomes in Adults With Problematic Cannabis Use
Status
Recruiting
People taking part
200 people, planned
Started
1 Jun 2023
Expected to end
31 Jul 2027
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Cognitive Behavioral Therapy for insomnia (CBTi-CB-TM)
  • Sleep Hygiene Education (SHE-TM)
Record updated
22 May 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with long-lasting insomnia who use cannabis regularly. It compares two sleep programs given by video call.

Age
21 years and older
Sex
All sexes
Disease stage
Chronic insomnia: trouble falling or staying asleep, or waking too early, on ≥3 nights a week for ≥3 months, with problems during the day. Insomnia Severity Index (ISI) score ≥11, meaning at least mild insomnia.
Earlier treatment
People who have had cognitive behavioral therapy for insomnia (CBTi) before cannot join. Cannabis use at least three times weekly for the past month is needed.
Biomarker or test result
A positive urine drug test for cannabis.

Main reasons for not taking part

  • Another sleep disorder besides insomnia
  • Ever diagnosed with a psychotic disorder or bipolar disorder, or current PTSD that disturbs sleep
  • Terminal or worsening illness, such as cancer or dementia
  • Pregnancy
  • Rotating or night shift work

The registry criteria, word for word

Show all 16 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Use of medications known to have initiated their insomnia (e.g., steroids)
  • Previous receipt of CBTi
  • 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)
  • Other conditions and situations, medical or otherwise, that preclude meaningful and/or safe participation in CNT/SHE and study procedures
  • Individuals who do not understand English (read and spoken)
  • Individuals judged unable to provide informed consent (e.g., intoxication, mental incompetence)
  • Self-reported pregnancy
  • Self-reported regular work schedule of rotating or night (3rd) shift work

Where in United States

  • University of MichiganAnn Arbor, United StatesContact: Libby Cardoni, MSTaking people

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • Cognitive Behavioral Therapy for insomnia (CBTi-CB-TM)Treatment being tested

    Delivered via telemedicine

  • Sleep Hygiene EducationExisting treatment, for comparison

    Delivered via telemedicine

    Treatment: Sleep Hygiene Education (SHE-TM)

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Targeting Insomnia to Improve Outcomes in Adults With Problematic Cannabis Use
Plain-language title
Remote sleep therapy for insomnia in adults who use cannabisGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Publications
Record updated
22 May 2026