Your session is about to expire
← Back to Search
CBT for Insomnia in Cannabis Users
N/A
Recruiting
Led By Todd Arnedt, PhD
Research Sponsored by University of Michigan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 months after intervention, approximately 32 weeks
Awards & highlights
Study Summary
This trial will compare two telemedicine treatments for sleep: one tailored to cannabis users and one focused on improving sleep hygiene. Results will show effects on sleep, cannabis use, daytime functioning, and more.
Who is the study for?
Adults with mild insomnia and problematic cannabis use, using cannabis for sleep at least three times a week. Must have stable housing, Wi-Fi access, and be able to visit Ann Arbor for assessments. Excludes non-English speakers, those unable to consent, diagnosed with certain mental disorders or on night shifts.Check my eligibility
What is being tested?
The trial is testing if cognitive behavioral therapy for insomnia via telemedicine (CBTi-CB-TM) is more effective than just sleep hygiene education (SHE-TM) in improving sleep quality, reducing cannabis use, and enhancing daytime function in adults who use cannabis for sleep.See study design
What are the potential side effects?
Since the interventions are non-pharmacological therapies focusing on behavior modification and education about good sleeping habits, significant side effects are not expected. However, participants may experience discomfort discussing personal habits or changing their routines.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 6 months after intervention, approximately 32 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 months after intervention, approximately 32 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Frequency of cannabis use as measured by the Timeline Followback (TLFB)
Insomnia Severity Index (ISI) total score measured by the Insomnia Severity Index (ISI)
Mental Composite Score (MCS-12) as assessed by the 12-item Short-Form Health Survey (SF-12)
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Cognitive Behavioral Therapy for insomnia (CBTi-CB-TM)Experimental Treatment1 Intervention
Delivered via telemedicine
Group II: Sleep Hygiene EducationActive Control1 Intervention
Delivered via telemedicine
Find a Location
Who is running the clinical trial?
National Institute on Drug Abuse (NIDA)NIH
2,469 Previous Clinical Trials
2,619,209 Total Patients Enrolled
4 Trials studying Insomnia
276 Patients Enrolled for Insomnia
University of MichiganLead Sponsor
1,797 Previous Clinical Trials
6,377,858 Total Patients Enrolled
9 Trials studying Insomnia
1,249 Patients Enrolled for Insomnia
Todd Arnedt, PhDPrincipal InvestigatorUniversity of Michigan
1 Previous Clinical Trials
65 Total Patients Enrolled
1 Trials studying Insomnia
65 Patients Enrolled for Insomnia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am capable of understanding and consenting to participate.I have long-term trouble sleeping.I do not understand English.I have been diagnosed with a psychotic disorder, bipolar disorder, or PTSD.My insomnia started after I began taking certain medications like steroids.I have previously undergone cognitive behavioral therapy for insomnia.I have mild or worse insomnia according to the ISI score.I have a terminal illness or a worsening neurological condition.I have a stable home, Wi-Fi, and can travel to Ann Arbor for tests.I am suspected to have a sleep disorder that is not insomnia.
Research Study Groups:
This trial has the following groups:- Group 1: Cognitive Behavioral Therapy for insomnia (CBTi-CB-TM)
- Group 2: Sleep Hygiene Education
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are new participants still being admitted to this experiment?
"According to clinicaltrials.gov this specific study is not currently enrolling participants; however, the trial was last edited on April 3rd 2023 and there are 341 other trials presently recruiting new patients."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger