Recruiting

Insomnia

Sponsor:

University of Michigan

Code:

NCT05814822

Conditions

Insomnia

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

Cognitive Behavioral Therapy for insomnia (CBTi-CB-TM)

Sleep Hygiene Education (SHE-TM)

Study Details

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.

Conditions

Insomnia

Study ID

NCT05814822

Start date

Jun 1, 2023

Status verified date

May, 2026

Completion date

Jul 31, 2027

Anticipated

Primary completion date

Jul 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

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 Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: Cognitive Behavioral Therapy for insomnia (CBTi-CB-TM)

Delivered via telemedicine

active comparator: Sleep Hygiene Education

Delivered via telemedicine

Interventions

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.

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.

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 ]
  • Insomnia Severity Index (ISI) total score measured by the Insomnia Severity Index (ISI) [ Time Frame: 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) [ Time Frame: Up to 6 months after intervention, approximately 32 weeks ]

Central Contacts and Locations

Central contacts

Libby Cardoni

734.764.7175mehobson@med.umich.edu

Locations

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Libby Cardoni, MS

734-764-7175mehobson@med.umich.edu

Principal Investigator:

Todd Arnedt, PhD

More Information

Sponsor

University of Michigan

Last update posted

May 22, 2026

Last verified

May, 2026

Keywords

  • Cannabis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Michigan on 2026-05-22.