Actively Recruiting

Phase Not Applicable
Age: 21Years +
All Genders
NCT05814822

Targeting Insomnia to Improve Outcomes in Adults With Problematic Cannabis Use

Led by University of Michigan · Updated on 2025-08-21

200

Participants Needed

1

Research Sites

221 weeks

Total Duration

On this page

Sponsors

U

University of Michigan

Lead Sponsor

N

National Institute on Drug Abuse (NIDA)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Targeting Insomnia to Improve Outcomes in Adults With Problematic Cannabis Use

Who Can Participate

Age: 21Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 21 years of age or older
  • Self-reported chronic insomnia with difficulty initiating or maintaining sleep or early waking at least 3 nights per week for at least 3 months, causing daytime impairment
  • Insomnia Severity Index (ISI) score of 11 or higher
  • Positive urine drug screen for cannabis
  • Self-reported cannabis use at least three times weekly for the past month
  • Stable residence with consistent sleep arrangements, access to Wi-Fi, and ability to travel to Ann Arbor for sleep lab assessments
Not Eligible

You will not qualify if you...

  • Inability to understand English (read and spoken)
  • Unable to provide informed consent due to intoxication or mental incompetence
  • Diagnosis or suspicion of a sleep disorder other than insomnia
  • Lifetime diagnosis of psychotic disorder or bipolar disorder; current PTSD interfering with sleep
  • Terminal or progressive physical illness or neurological degenerative disease
  • Use of medications that caused insomnia (e.g., steroids)
  • Previous cognitive behavioral therapy for insomnia (CBTi)
  • Self-reported pregnancy
  • Regular rotating or night shift work schedule
  • Any other medical or non-medical condition preventing safe or meaningful participation in study procedures

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of Michigan

Ann Arbor, Michigan, United States, 48109

Actively Recruiting

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Research Team

L

Libby Cardoni

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

HEALTH_SERVICES_RESEARCH

Number of Arms

2

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