Targeting Insomnia to Improve Outcomes in Adults With Problematic Cannabis Use

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 Overview

• Status: Recruiting
• Conditions: Insomnia
• Intervention / Treatment: Behavioral: Cognitive Behavioral Therapy for insomnia (CBTi-CB-TM); Behavioral: Sleep Hygiene Education (SHE-TM)

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Libby Cardoni; Phone Number: 734.764.7175; Email: mehobson@med.umich.edu

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Recruiting
      • University of Michigan
      • Principal Investigator: Todd Arnedt, PhD
      • Sub-Investigator: Mark Illgen, PhD
      • Contact: Libby Cardoni, MS; Phone Number: 734-764-7175; Email: mehobson@med.umich.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

INCLUSION 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 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 CRITERIA

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cognitive Behavioral Therapy for insomnia (CBTi-CB-TM); Delivered via telemedicine	Behavioral: 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.
Active Comparator: Sleep Hygiene Education; Delivered via telemedicine	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Pre- and Post-Intervention

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Todd Arnedt, PhD, University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2027

Study Registration Dates

• First Submitted: April 3, 2023
• First Submitted That Met QC Criteria: April 3, 2023
• First Posted (Actual): April 18, 2023

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 19, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Cannabis
• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Initiation and Maintenance Disorders; Marijuana Abuse; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Cognitive Behavioral Therapy
• Other Study ID Numbers: HUM00222302; R01DA057297 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No