NCT06157840 Development of an mHealth Behavioral Sleep Medicine Intervention for Use During Medication Assisted Treatment for MOUD
| NCT ID | NCT06157840 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Medical University of South Carolina |
| Condition | Opioid Use Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2025-08-25 |
| Primary Completion | 2026-09-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2025-08-25 with a primary completion date of 2026-09-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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-related problems in opioid use disorder. An initial program will be built utilizing input from persons beginning medications for opioid use disorders.
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
Contact & Investigator
Allison K Wilkerson, Ph.D.
PRINCIPAL INVESTIGATOR
Medical University of South Carolina
Frequently Asked Questions
Who can join the NCT06157840 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Opioid Use Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06157840 currently recruiting?
Yes, NCT06157840 is actively recruiting participants. Contact the research team at wilkersa@musc.edu for enrollment information.
Where is the NCT06157840 trial being conducted?
This trial is being conducted at Charleston, United States.
Who is sponsoring the NCT06157840 clinical trial?
NCT06157840 is sponsored by Medical University of South Carolina. The principal investigator is Allison K Wilkerson, Ph.D. at Medical University of South Carolina. The trial plans to enroll 40 participants.