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

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 3 months later Sep 15, 2026 → Dec 15, 2026
See other at-risk trials from Medical University of South Carolina

Record History

  1. Primary endpoints: details revised at 2 of 3 entries Primary completion pushed from Sep 15, 2026 to Dec 15, 2026 · Completion pushed from Sep 30, 2026 to Dec 31, 2026 · Eligibility criteria expanded, about 14 words · 1 more Show 4 more changesShow less
    • Primary completion pushed from Sep 15, 2026 to Dec 15, 2026
    • Completion pushed from Sep 30, 2026 to Dec 31, 2026
    • Eligibility criteria expanded, about 14 words
    • Site contact updated
  2. Primary completion pushed from Jun 30, 2026 to Sep 15, 2026 Completion pushed from Jul 17, 2026 to Sep 30, 2026 · Site contact updatedv9 Show 2 more changesShow less
    • Completion pushed from Jul 17, 2026 to Sep 30, 2026
    • Site contact updated
  3. Primary completion date: Mar 20, 2026 to Jun 30, 2026 Completion date: May 1, 2026 to Jul 17, 2026 · Site contact updatedv8 Show 2 more changesShow less
    • Completion date: May 1, 2026 to Jul 17, 2026
    • Site contact updated
  4. Primary completion date: Apr 30, 2026 to Mar 20, 2026 Completion date: Apr 30, 2026 to May 1, 2026v7 Show 1 more changeShow less
    • Completion date: Apr 30, 2026 to May 1, 2026
  5. Primary completion date: Apr 1, 2026 to Apr 30, 2026 Completion date: May 1, 2026 to Apr 30, 2026 · Start date: Aug 15, 2025 to Aug 25, 2025v6 Show 2 more changesShow less
    • Completion date: May 1, 2026 to Apr 30, 2026
    • Start date: Aug 15, 2025 to Aug 25, 2025
Show 4 earlier versionsHide 4 earlier versions
  1. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Start date changed from estimate of Aug 7, 2025 to Aug 15, 2025v5 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Aug 7, 2025 to Aug 15, 2025
  2. Start date: Jul 1, 2025 to Aug 7, 2025v4
  3. Start date: Feb 1, 2025 to Jul 1, 2025 Primary completion date: Feb 1, 2026 to Apr 1, 2026v3 Show 1 more changeShow less
    • Primary completion date: Feb 1, 2026 to Apr 1, 2026
  4. Primary endpoints revised (3)v2 See this version in full on ClinicalTrials.gov ↗
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06157840
Lead Sponsor Medical University of South Carolina
Collaborators: National Institute on Drug Abuse (NIDA)
Conditions Opioid Use Disorder, Poor Quality Sleep
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov