BridgeMD
New treatment option for Insomnia
Official title Targeting Insomnia to Improve Outcomes in Adults With Problematic Cannabis Use
ClinicalTrials.gov ID: NCT05814822
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 and older
You may be able to join if
- 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...
- 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
You likely can't join if
- 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)
See the full eligibility 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...
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Ann Arbor, Michigan, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ann Arbor, Michigan, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.