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

Launched by MEDICAL UNIVERSITY OF SOUTH CAROLINA · Nov 27, 2023

Keywords

ClinConnect Summary

This clinical trial is focused on developing a mobile health application designed to help people who are struggling with sleep problems, especially those undergoing treatment for opioid use disorder (OUD). The program will use techniques from cognitive behavioral therapy for insomnia, which is a type of therapy that helps people change their thoughts and behaviors around sleep to improve its quality. Researchers will start by working with individuals who are beginning medication treatment for OUD to create a program that addresses their specific sleep-related challenges.

To be eligible for this study, participants must be at least 18 years old, currently stabilized on a medication called buprenorphine (used to treat OUD), and experiencing significant sleep disturbances. They should also have a smartphone and be able to read and understand English. However, individuals with severe mental health issues, active suicidal thoughts, or other substance use disorders will not be eligible. As the study is not yet recruiting, participants can expect to contribute to the development of a supportive tool that could help many others facing similar challenges with sleep and recovery in the future.

Gender

ALL

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