Targeting Insomnia to Improve Outcomes in Adults With Problematic Cannabis Use
2 other identifiers
interventional
200
1 country
1
Brief 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. We will also evaluate the effects of CBTi-CB-TM on fundamental sleep regulatory system - homeostatic sleep drive - and its association with clinical outcomes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2023
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 3, 2023
CompletedFirst Posted
Study publicly available on registry
April 18, 2023
CompletedStudy Start
First participant enrolled
June 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 31, 2027
May 22, 2026
May 1, 2026
4.2 years
April 3, 2023
May 19, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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.
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.
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
Up to 6 months after intervention, approximately 32 weeks
Secondary Outcomes (1)
EEG Delta Activity
Pre- and Post-Intervention
Study Arms (2)
Cognitive Behavioral Therapy for insomnia (CBTi-CB-TM)
EXPERIMENTALDelivered via telemedicine
Sleep Hygiene Education
ACTIVE COMPARATORDelivered via telemedicine
Interventions
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.
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
You may qualify if:
- 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
You may not qualify 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)
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Michiganlead
- National Institute on Drug Abuse (NIDA)collaborator
Study Sites (1)
University of Michigan
Ann Arbor, Michigan, 48109, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Todd Arnedt, PhD
University of Michigan
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Psychiatry, Professor of Neurology
Study Record Dates
First Submitted
April 3, 2023
First Posted
April 18, 2023
Study Start
June 1, 2023
Primary Completion (Estimated)
July 31, 2027
Study Completion (Estimated)
July 31, 2027
Last Updated
May 22, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Time Frame
- Data will be available starting one year following the primary completion date of the study. There is no end date for data accessibility on the NDA.
- Access Criteria
- Data are available only for research purposes to users who complete the NDA Data Use Certification. Certifications are accepted only from researchers who are sponsored by an institution registered in the NIH eRA Commons. The application to access data must include a specific reason for access related to scientific investigation, scholarship, or other research.
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.