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RECRUITING Not applicable ClinicalTrials.gov

Development of an mHealth Behavioral Sleep Medicine Intervention for Use During Medication Assisted Treatment for MOUD

Sponsor: Medical University of South Carolina • ClinicalTrials.gov ID: NCT06157840

Registry updated: 2026-09-28
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Description

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-related problems in opioid use disorder. An initial program will be built utilizing input from persons beginning medications for opioid use disorders.

Interventions

  • mHealth application and sleep health education (Device)
    Study participants will download the mHealth app to their smartphones and complete the intervention within 6 weeks. They will be required to complete daily electronic sleep diaries for the following 6 weeks. Each week, they will be asked to complete a short assessment of their experiences from the previous week and their current insomnia severity
  • Simplified mHealth application and sleep health education (Device)
    Study participants will download the mHealth app to their smartphones and complete the intervention within 6 weeks. They will receive a simplified version of the app with sleep hygiene instructions and will be required to complete daily electronic sleep diaries for the following 6 weeks. Each week, they will be asked to complete a short assessment of their experiences from the previous week and their current insomnia severity.

Eligibility criteria

Inclusion Criteria: * No experience of withdrawal symptoms in past 2 weeks * Being stabilized on buprenorphine 1. Initiated buprenorphine in past 3 months 2. 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 Criteria: * 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

Conditions

Opioid Use Disorder Poor Quality Sleep

Locations

  • Medical University of South Carolina — Charleston, South Carolina, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record