Targeting Insomnia to Improve Outcomes in Adults With Problematic Cannabis Use

Insomnia Clinical Trial

Official title:

Targeting Insomnia to Improve Outcomes in Adults With Problematic Cannabis Use

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05814822
• Other study ID #: HUM00222302
• Secondary ID: R01DA057297
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2023
• Est. completion date: August 2027

Study information

• Verified date: June 2023
• Source: University of Michigan
• Contact: Mandilyn Graham
• Phone: 734-232-0276
• Email: grmandil[@]med.umich.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: August 2027
• Est. primary completion date: August 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Insomnia
• Marijuana Abuse
• Sleep Initiation and Maintenance Disorders

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of cannabis use as measured by the Timeline Followback (TLFB)	The TLFB is an interviewer-administered calendar-guided instrument that is the gold standard tool for assessing daily substance use.	Up to 6 months after intervention, approximately 32 weeks
Primary	Insomnia Severity Index (ISI) total score measured by the Insomnia Severity Index (ISI)	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.	Up to 6 months after intervention, approximately 32 weeks
Primary	Mental Composite Score (MCS-12) as assessed by the 12-item Short-Form Health Survey (SF-12)	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.	Up to 6 months after intervention, approximately 32 weeks