Targeting Insomnia to Improve Outcomes in Adults With Problematic Cannabis Use

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 21
Healthy Volunteers: f
View:

• 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

Locations
United States
Michigan
University of Michigan
RECRUITING
Ann Arbor
Contact Information
Primary
Libby Cardoni
mehobson@med.umich.edu
734.764.7175
Time Frame
Start Date: 2023-06-01
Estimated Completion Date: 2027-08-31
Participants
Target number of participants: 200
Treatments
Experimental: Cognitive Behavioral Therapy for insomnia (CBTi-CB-TM)
Delivered via telemedicine
Active_comparator: Sleep Hygiene Education
Delivered via telemedicine
Related Therapeutic Areas
Sponsors
Collaborators: National Institute on Drug Abuse (NIDA)
Leads: University of Michigan

This content was sourced from clinicaltrials.gov