Development of an mHealth Behavioral Sleep Medicine Intervention for Use During Medication Assisted Treatment for Opioid Use Disorder
Sponsor: Medical University of South Carolina
Trial Details
| Condition | Opioid Use Disorder, Poor Quality Sleep |
| Intervention | mHealth application and sleep health education; Simplified mHealth application and sleep health education |
| Phase | NA |
| Status | Recruiting |
| Participants | 40 |
| Est. Completion | 15 Sept 2026 |
| Last Updated | 12 May 2026 |
Primary Outcome
Enrollment feasibility/acceptability benchmark of at least 30 persons completing entire study period - Enrollment and retention percentages; Protocol adherence feasibility/acceptability benchmarks of participants completing modules and sleep diaries each week - Engagement; mHealth App Usability Questionnaire
Eligibility Criteria
Inclusion 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
Trial Sites
Countries
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