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Recruiting NCT05814822

Targeting Insomnia to Improve Outcomes in Adults With Problematic Cannabis Use

No phase Interventional Insomnia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cognitive Behavioral Therapy for insomnia (CBTi-CB-TM), Sleep Hygiene Education (SHE-TM).
Who it may be relevant to
Registry conditions: Insomnia. Basic parameters: from 21 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • 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.
  • 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.

Primary outcome measures

  • 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]
Secondary outcome measures (1)
  • EEG Delta Activity [Time frame: Pre- and Post-Intervention]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Health services research

Study locations

United States · 1 center
  • University of Michigan — Ann Arbor

Publications

  • Bolling C, Cardoni ME, Conroy DA, Price A, Goldstick JE, Bourgoise M, Bonar EE, Krystal A, Ilgen MA, Arnedt JT. Cognitive-behavioural therapy for insomnia in adults to decrease cannabis use: study protocol for a randomised controlled trial in a community sample of adults with frequent cannabis use. BMJ Open. 2026 Jun 17;16(6):e116524. doi: 10.1136/bmjopen-2026-116524. PMID 42309658

Identifiers

NCT: NCT05814822 · HUM00222302 · R01DA057297

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗