NCT06157840 · Medical University of South Carolina
Development of an mHealth Behavioral Sleep Medicine Intervention for Use During Medication Assisted Treatment for MOUD
What this study is about
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.
View original scientific description
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.
Interventions
DEVICE
mHealth application and sleep health education
Study participants will download the mHealth app to their smartphones and complete the intervention within 6 weeks. They will be required to complete daily electronic sleep diaries for the following 6 weeks. Each week, they will be asked to complete a short assessment of their experiences from the previous week and their current insomnia severity
DEVICE
Simplified mHealth application and sleep health education
Study participants will download the mHealth app to their smartphones and complete the intervention within 6 weeks. They will receive a simplified version of the app with sleep hygiene instructions and will be required to complete daily electronic sleep diaries for the following 6 weeks. Each week, they will be asked to complete a short assessment of their experiences from the previous week and their current insomnia severity.
Primary outcome measures
Enrollment feasibility/acceptability benchmark of at least 30 persons completing entire study period - Enrollment and retention percentages
Time frame: 6 weeks following enrollment
To achieve a minimum enrollment and retention percentage of 75% throughout the 6-week investigation period.
Protocol adherence feasibility/acceptability benchmarks of participants completing modules and sleep diaries each week - Engagement
Time frame: 6 weeks following enrollment
Completing at least one module per week, submitting a minimum of four sleep diaries per week, and implementing stimulus control and sleep restriction on at least 90% of nights.
mHealth App Usability Questionnaire
Time frame: 6 weeks following enrollment
Validated measure of mobile app usability with 3 sections: Ease of use/satisfaction, system information arrangement, and usefulness
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- No experience of withdrawal symptoms in past 2 weeks
- Being stabilized on buprenorphine
- Initiated buprenorphine in past 3 months
- 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
Where
- Charleston, South Carolina
Collaborators
National Institute on Drug Abuse (NIDA)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 12, 2026 · Source of record for eligibility and locations