search
Back to results

Targeting Insomnia to Improve Outcomes in Adults With Problematic Cannabis Use

Primary Purpose

Insomnia

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Behavioral Therapy for insomnia (CBTi-CB-TM)
Sleep Hygiene Education (SHE-TM)
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Insomnia focused on measuring Cannabis

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of MichiganRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cognitive Behavioral Therapy for insomnia (CBTi-CB-TM)

Sleep Hygiene Education

Arm Description

Delivered via telemedicine

Delivered via telemedicine

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
April 3, 2023
Last Updated
June 2, 2023
Sponsor
University of Michigan
Collaborators
National Institute on Drug Abuse (NIDA)
search

1. Study Identification

Unique Protocol Identification Number
NCT05814822
Brief Title
Targeting Insomnia to Improve Outcomes in Adults With Problematic Cannabis Use
Official Title
Targeting Insomnia to Improve Outcomes in Adults With Problematic Cannabis Use
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2023 (Actual)
Primary Completion Date
August 2027 (Anticipated)
Study Completion Date
August 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia
Keywords
Cannabis

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cognitive Behavioral Therapy for insomnia (CBTi-CB-TM)
Arm Type
Experimental
Arm Description
Delivered via telemedicine
Arm Title
Sleep Hygiene Education
Arm Type
Active Comparator
Arm Description
Delivered via telemedicine
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy for insomnia (CBTi-CB-TM)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Sleep Hygiene Education (SHE-TM)
Intervention Description
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 Measure Information:
Title
Frequency of cannabis use as measured by the Timeline Followback (TLFB)
Description
The TLFB is an interviewer-administered calendar-guided instrument that is the gold standard tool for assessing daily substance use.
Time Frame
Up to 6 months after intervention, approximately 32 weeks
Title
Insomnia Severity Index (ISI) total score measured by the Insomnia Severity Index (ISI)
Description
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.
Time Frame
Up to 6 months after intervention, approximately 32 weeks
Title
Mental Composite Score (MCS-12) as assessed by the 12-item Short-Form Health Survey (SF-12)
Description
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.
Time Frame
Up to 6 months after intervention, approximately 32 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mandilyn Graham
Phone
734-232-0276
Email
grmandil@med.umich.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Todd Arnedt, PhD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mandilynn Graham
Phone
734-232-0276
Email
grmandil@med.umich.edu
First Name & Middle Initial & Last Name & Degree
Todd Arnedt, PhD
First Name & Middle Initial & Last Name & Degree
Mark Illgen, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Targeting Insomnia to Improve Outcomes in Adults With Problematic Cannabis Use

We'll reach out to this number within 24 hrs