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

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

Who can join

Ages 18 and older · All sexes

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

About the study

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.

What is being tested

• mHealth application and sleep health education (device)
• Simplified mHealth application and sleep health education (device)

Sponsor: Medical University of South Carolina · Participants: 40 · Started: Aug 25, 2025

Contact the study team

• Allison K Willkerson, Ph.D. · Phone: 843-792-4636

Official record on ClinicalTrials.gov — NCT06157840

Locations in the U.S.

Conditions

• Opioid Overdose

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.