Targeting Insomnia to Improve Outcomes in Adults With Problematic Cannabis Use

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
University of Michigan
Study ID
NCT05814822
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cognitive Behavioral Therapy for insomnia (CBTi-CB-TM) — BEHAVIORAL
    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) — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Jun 1, 2023
Status verified
May 2026
Primary completion
Jul 31, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: Cognitive Behavioral Therapy for insomnia (CBTi-CB-TM)
    Delivered via telemedicine
  • Active Comparator: Sleep Hygiene Education
    Delivered via telemedicine

Primary Outcome Measure

Frequency of cannabis use as measured by the Timeline Followback (TLFB) [ Time Frame: Up to 6 months after intervention, approximately 32 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MichiganAnn ArborMichigan48109
Libby Cardoni, MS
[email protected]
734-764-7175
Todd Arnedt, PhD (PRINCIPAL_INVESTIGATOR)
Mark Illgen, PhD (SUB_INVESTIGATOR)

Find similar trials in Ann Arbor, MI

By condition
Insomnia
By specialty
Mental healthSleep medicine
By research site
University of Michigan· Ann Arbor, MI

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