InsomniaNCT05814822
Targeting Insomnia to Improve Outcomes in Adults With Problematic Cannabis Use
A study testing Cognitive Behavioral Therapy for insomnia (CBTi-CB-TM) and Sleep Hygiene Education (SHE-TM) in people with Insomnia, run by University of Michigan at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Insomnia
- What is being tested?
- Cognitive Behavioral Therapy for insomnia (CBTi-CB-TM) and Sleep Hygiene Education (SHE-TM)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2023to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- 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)
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- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
Libby Cardoni, MS, 734-764-7175, mehobson@med.umich.edu
Todd Arnedt, PhD
About this study
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.
- Conditions
- Insomnia
- Being tested
- Cognitive Behavioral Therapy for insomnia (CBTi-CB-TM), Sleep Hygiene Education (SHE-TM)
- Keywords
- Cannabis
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Therapy for insomnia (CBTi-CB-TM)Behavioural
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)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Behavioral Therapy for insomnia (CBTi-CB-TM) | Experimental | Delivered via telemedicine Receives: Behavioral: Cognitive Behavioral Therapy for insomnia (CBTi-CB-TM) |
| Sleep Hygiene Education | Active comparator | Delivered via telemedicine Receives: Behavioral: Sleep Hygiene Education (SHE-TM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of cannabis use as measured by the Timeline Followback (TLFB)
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.
Measured: Up to 6 months after intervention, approximately 32 weeks
Insomnia Severity Index (ISI) total score measured by the Insomnia Severity Index (ISI)
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.
Measured: Up to 6 months after intervention, approximately 32 weeks
Mental Composite Score (MCS-12) as assessed by the 12-item Short-Form Health Survey (SF-12)
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
Measured: Up to 6 months after intervention, approximately 32 weeks
Secondary outcomes (1)
EEG Delta Activity
The outcome of interest is change in the rate of dissipation of Non-Rapid Eye Movement (NREM) sleep Slow Wave Activity (SWA) over the course of the night (measured with the best-fit slope based on exponential regressions), but we will additionally evaluate change in SWA power in the first NREM period and averaged across the night
Measured: Pre- and Post-Intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start1 Jun 2023
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, J. Todd Arnedt, University of Michigan
- Investigators
- Todd Arnedt, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05814822
- Sponsor's protocol ID
- HUM00222302
- Other IDs
- R01DA057297
- Status last verified
- May 2026
- First submitted
- 3 Apr 2023
- Last updated
- 22 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified participant data will be uploaded biannually into the NIMH National Data Archive. This archive is accessible only by other researchers who are members and agree to data access protocols. All participant identifiers are stripped and data are uploaded using a Global Unique Identifier. Data to be shared include responses to self-report measures and polysomnography. In accordance with ClinicalTrials.gov guidelines, results will be shared here no later than one year after primary study completion.
Publications
Bolling C, Cardoni ME, Conroy DA, Price A, Goldstick JE, Bourgoise M, Bonar EE, Krystal A, Ilgen MA, Arnedt JT. Cognitive-behavioural therapy for insomnia in adults to decrease cannabis use: study protocol for a randomised controlled trial in a community sample of adults with frequent cannabis use. BMJ Open. 2026 Jun 17;16(6):e116524. doi: 10.1136/bmjopen-2026-116524.
PubMed 42309658
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting Insomnia to Improve Outcomes in Adults With Problematic Cannabis Use
- ClinicalTrials.gov ID
- NCT05814822
- Acronym / sponsor ID
- HUM00222302
- Conditions
- Insomnia
- Keywords
- Cannabis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 18 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavioral Therapy for insomnia (CBTi-CB-TM) | Experimental | Behavioral: Cognitive Behavioral Therapy for insomnia (CBTi-CB-TM)Delivered via telemedicine |
| Sleep Hygiene Education | Active comparator | Behavioral: Sleep Hygiene Education (SHE-TM)Delivered via telemedicine |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Cognitive Behavioral Therapy for insomnia (CBTi-CB-TM) |
| 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. | Behavioural | Sleep Hygiene Education |
Primary outcome
Frequency of cannabis use as measured by the Timeline Followback (TLFB)
Time frame: 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)
Time frame: 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)
Time frame: 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
1 secondary outcome
EEG Delta Activity
Time frame: Pre- and Post-Intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Derived from this study: PubMed 42309658Bolling C, Cardoni ME, Conroy DA, Price A, Goldstick JE, Bourgoise M, Bonar EE, Krystal A, Ilgen MA, Arnedt JT. Cognitive-behavioural therapy for insomnia in adults to decrease cannabis use: study protocol for a randomised controlled trial in a community sample of adults with frequent cannabis use. BMJ Open. 2026 Jun 17;16(6):e116524. doi: 10.1136/bmjopen-2026-116524.
- Individual participant dataSharing planned: Yes. De-identified participant data will be uploaded biannually into the NIMH National Data Archive. This archive is accessible only by other researchers who are members and agree to data access protocols. All participant identifiers are stripped and data are uploaded using a Global Unique Identifier. Data to be shared include responses to self-report measures and polysomnography. In accordance with ClinicalTrials.gov guidelines, results will be shared here no later than one year after primary study completion.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Todd Arnedt, PhD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy for insomnia (CBTi-CB-TM) and Sleep Hygiene Education (SHE-TM) in people with Insomnia, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Libby Cardoni (734.764.7175, mehobson@med.umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of cannabis use as measured by the Timeline Followback (TLFB) (time frame: Up to 6 months after intervention, approximately 32 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05814822, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.