Status:
RECRUITING
Development of an mHealth Behavioral Sleep Medicine Intervention for Use During Medication Assisted Treatment for MOUD
Lead Sponsor:
Medical University of South Carolina
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Opioid Use Disorder
Poor Quality Sleep
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study is to develop and test a medical health application based on cognitive behavioral therapy for insomnia and augmented with other evidence-based sleep interventions that address common sleep-...
Detailed Description
This pilot randomized controlled trial will assess the feasibility and acceptability of an evidence-based behavioral sleep intervention delivered via a mHealth app to individuals initiating treatment ...
Eligibility Criteria
Inclusion
- No experience of withdrawal symptoms in past 2 weeks
- Being stabilized on buprenorphine
- Initiated buprenorphine in past 3 months
- Modified buprenorphine dose in past 3 months (e.g., reducing dose with goal of transitioning to vivitrol)
- Currently experiencing clinically significant sleep disturbance (PSQI \> 5)
- Able to read and understand English
- Owns an Android or iOS smartphone
- At least 18 years of age
Exclusion
- Current psychotic symptoms
- Current active suicidal ideation
- Severe visual impairment
- Current use of benzodiazepines
- Current severe SUD other than OUD (i.e., \> 5 criteria met for any other SUD type per DSM-5)
- Peripartum women
Key Trial Info
Start Date :
August 25 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06157840
Start Date
August 25 2025
End Date
April 30 2026
Last Update
December 17 2025
Active Locations (1)
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1
Medical University of South Carolina
Charleston, South Carolina, United States, 29464