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CBT for Insomnia in Cannabis Users

N/A
Waitlist Available
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
No Placebo-Only Group

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.
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.
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 weeks
Treatment ~ Varies
Follow Up ~up to 6 months after intervention, approximately 32 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months after intervention, approximately 32 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
2,586 Previous Clinical Trials
3,328,330 Total Patients Enrolled
5 Trials studying Insomnia
390 Patients Enrolled for Insomnia
University of MichiganLead Sponsor
1,853 Previous Clinical Trials
6,432,825 Total Patients Enrolled
10 Trials studying Insomnia
1,537 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

Cognitive Behavioral Therapy for insomnia Clinical Trial Eligibility Overview. Trial Name: NCT05814822 — N/A
Insomnia Research Study Groups: Cognitive Behavioral Therapy for insomnia (CBTi-CB-TM), Sleep Hygiene Education
Insomnia Clinical Trial 2023: Cognitive Behavioral Therapy for insomnia Highlights & Side Effects. Trial Name: NCT05814822 — N/A
Cognitive Behavioral Therapy for insomnia 2023 Treatment Timeline for Medical Study. Trial Name: NCT05814822 — N/A
~132 spots leftby Aug 2027
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