Targeting Insomnia to Improve Outcomes in Adults with Problematic Cannabis Use

Not Applicable

Recruiting

• Conditions: Insomnia
• Interventions: Behavioral: Sleep Hygiene Education (SHE-TM); Behavioral: Cognitive Behavioral Therapy for insomnia (CBTi-CB-TM)

• Registration Number: NCT05814822
• Lead Sponsor: University of Michigan

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-04-03
• Study First Submitted QC: 2023-04-03
• Study First Posted: 2023-04-18
• Study Start: 2023-06-01
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-05
• Last Update Posted: 2024-12-11
• Primary Completion: 2027-08-31
• Study Completion: 2027-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Self-reported chronic insomnia
• Insomnia Severity Index (ISI) score indicative of at least mild insomnia
• Cannabis Use Disorder Identification Test-Revised (CUDIT-R) indicative of at least problematic cannabis use
• A positive urine drug screen (UDS) for cannabis
• Self-reported use of cannabis to manage insomnia 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
• Individuals judged unable to provide informed consent (e.g., intoxication, mental incompetence)
• Diagnosis or high suspicion of a sleep disorder other than insomnia
• Diagnosis of psychotic disorder, bipolar disorder, or post-traumatic stress disorder
• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sleep Hygiene Education	Sleep Hygiene Education (SHE-TM)	Delivered via telemedicine
Cognitive Behavioral Therapy for insomnia (CBTi-CB-TM)	Cognitive Behavioral Therapy for insomnia (CBTi-CB-TM)	Delivered via telemedicine

Primary Outcome Measures

Name	Time	Method
Frequency of cannabis use as measured by the Timeline Followback (TLFB)	Up to 6 months after intervention, approximately 32 weeks	The TLFB is an interviewer-administered calendar-guided instrument that is the gold standard tool for assessing daily substance use.
Insomnia Severity Index (ISI) total score measured by the Insomnia Severity Index (ISI)	Up to 6 months after intervention, approximately 32 weeks	The ISI is a 7-item questionnaire used to examine insomnia severity over the past 2 weeks. Scores range from 0-28 with higher scores indicating greater insomnia symptom severity.
Mental Composite Score (MCS-12) as assessed by the 12-item Short-Form Health Survey (SF-12)	Up to 6 months after intervention, approximately 32 weeks	The MCS-12 is a composite score derived from the 12-item Short-Form Health Survey quality of life measure. Scores range from 0-100 with higher scores indicating better health.

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States