RECRUITING

Targeting Insomnia to Improve Outcomes in Adults with Problematic Cannabis Use

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InsomniaCannabis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Targeting Insomnia to Improve Outcomes in Adults with Problematic Cannabis Use

Quick Facts

Study Start:2023-06-01
Study Completion:2027-08-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05814822

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Self-reported chronic insomnia
  2. * Insomnia Severity Index (ISI) score indicative of at least mild insomnia
  3. * Cannabis Use Disorder Identification Test-Revised (CUDIT-R) indicative of at least problematic cannabis use
  4. * A positive urine drug screen (UDS) for cannabis
  5. * Self-reported use of cannabis to manage insomnia at least three times weekly for the past month
  6. * Stable residence (e.g., stable sleep arrangements), consistent access to Wi-Fi, and ability to travel to Ann Arbor for sleep laboratory assessments
  1. * Individuals who do not understand English
  2. * Individuals judged unable to provide informed consent (e.g., intoxication, mental incompetence)
  3. * Diagnosis or high suspicion of a sleep disorder other than insomnia
  4. * Diagnosis of psychotic disorder, bipolar disorder, or post-traumatic stress disorder
  5. * Terminal or progressive physical illness (e.g., cancer) or neurological degenerative disease (e.g., dementia)
  6. * Use of medications known to have initiated their insomnia (e.g., steroids)
  7. * Previous receipt of CBTi
  8. * Self-reported pregnancy
  9. * Self-reported regular work schedule of rotating or night (3rd) shift work.

Contacts and Locations

Study Contact

Libby Cardoni
CONTACT
734.764.7175
mehobson@med.umich.edu

Principal Investigator

Todd Arnedt, PhD
PRINCIPAL_INVESTIGATOR
University of Michigan

Study Locations (Sites)

University of Michigan
Ann Arbor, Michigan, 48109
United States

Collaborators and Investigators

Sponsor: University of Michigan

  • Todd Arnedt, PhD, PRINCIPAL_INVESTIGATOR, University of Michigan

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-06-01
Study Completion Date2027-08-31

Study Record Updates

Study Start Date2023-06-01
Study Completion Date2027-08-31

Terms related to this study

Keywords Provided by Researchers

  • Cannabis

Additional Relevant MeSH Terms

  • Insomnia