mHealth Sleep Intervention for Opioid Use Disorder

Overseen By Jacelyn Lane

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medical University of South Carolina

Must be taking: Buprenorphine

Must not be taking: Benzodiazepines

Disqualifiers: Psychotic symptoms, Suicidal ideation, Severe SUD, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a smartphone app designed to assist people with opioid use disorder who also struggle with sleep. The app uses cognitive behavioral therapy, a type of talk therapy that helps improve sleep. Participants will use this mHealth Behavioral Sleep Medicine Intervention while stabilized on buprenorphine, a medication for opioid use disorder, and will track their sleep for six weeks. Individuals who have started or adjusted their buprenorphine dose in the last three months and experience significant sleep problems are well-suited for this trial. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance sleep and recovery for many others.

Do I have to stop taking my current medications for the trial?

The trial requires that you are stabilized on buprenorphine, but you cannot be using benzodiazepines. Other medications are not specifically mentioned, so it's best to discuss with the trial team.

What prior data suggests that this mHealth application is safe for individuals with opioid use disorder?

Research shows that people prefer using the mHealth Behavioral Sleep Medicine Intervention app. Tests of similar sleep apps have demonstrated ease of use and positive user feedback. Although specific safety data for this app in the trial is unavailable, similar sleep apps generally pose very low risk. They do not involve physical procedures and primarily help track sleep and offer improvement tips.

The app employs cognitive behavioral therapy for insomnia, a well-known and safe method for managing sleep problems, with no known harmful side effects. It aids users in improving sleep habits. Designed to complement medications for opioid use disorder, the app provides additional support rather than serving as the sole treatment.

Overall, using an app like this is expected to be safe and manageable. Participants will mainly engage with educational content and track their sleep, which is non-invasive. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a novel approach to improving sleep in individuals with opioid use disorder using a mobile health (mHealth) application. Unlike traditional treatments that may rely on medication or in-person therapy for insomnia, this method leverages technology to provide a behavioral sleep medicine intervention directly through a smartphone app. Participants engage with the app to track their sleep and receive tailored guidance, which can be more accessible and flexible than conventional options. Additionally, the control group receives education on sleep hygiene via the app, offering a streamlined way to promote better sleep habits. This trial could lead to a more convenient and scalable solution for managing sleep issues in this population.

What evidence suggests that this mHealth application is effective for improving sleep in individuals with opioid use disorder?

This trial will compare two approaches using a mobile health app for sleep intervention in individuals with opioid use disorder. Research has shown that mobile health apps using cognitive behavioral therapy (CBT) for insomnia can improve sleep. Early studies suggest these apps may benefit people with opioid use disorder by addressing common sleep issues. Testing of similar apps indicates they are user-friendly and effective. This method combines proven sleep improvement techniques with technology, making it easy to use and adaptable. Overall, early evidence suggests these digital tools could support better sleep during opioid addiction treatment. ^{1 2 3 5 6}

Who Is on the Research Team?

Allison K Wilkerson, Ph.D.

Principal Investigator

Medical University of South Carolina

Are You a Good Fit for This Trial?

This trial is for individuals on buprenorphine to manage opioid use disorders, who've started treatment within the last 3 months and are stable with no withdrawal in the past 2 weeks. Participants must have sleep disturbances, own a smartphone, and be able to read English. Those adjusting their dose for transitioning treatments can also join.

Inclusion Criteria

You have not had withdrawal symptoms in the past 2 weeks.

You started taking buprenorphine in the last 3 months.

You can read and understand English.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage with the mHealth application for 6 weeks, completing daily electronic sleep diaries and weekly assessments

6 weeks

Weekly virtual assessments

Follow-up

Participants are monitored for changes in sleep disturbance and insomnia severity after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• mHealth Behavioral Sleep Medicine Intervention

Trial Overview The study is testing two versions of an mHealth app designed using cognitive behavioral therapy principles to improve sleep among those undergoing medication-assisted treatment for opioid use disorder. It aims to see how effective these apps are when combined with sleep health education.

How Is the Trial Designed?

Group I: mHealth application Experimental Treatment 1 Intervention

Study participants, while being stabilized on buprenorphine, will download and engage with the developed mHealth application, completing daily electronic sleep diaries for the next 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.

Group II: Control Group Experimental Treatment 1 Intervention

Participants in the control group will receive a simplified version of the app with sleep hygiene (SH) instructions and will be required to complete daily electronic sleep diaries for the next 6 weeks. The SH condition will utilize the same application and entail the same daily and weekly logs, but with the didactic material replaced by detailed education about SH strategies. Each week, participants will be asked to complete a brief assessment of their experiences from the previous week and their current insomnia severity.

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials

994

Recruited

7,408,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Citations

1. reporter.nih.gov reporter.nih.gov/project-details/10681901

Project Details - NIH RePORTER The proposed research will develop and test a behavioral sleep medicine- based mobile application that includes components of interventions for sleep problems.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06157840?term=AREA%5BConditionSearch%5D(Diseases%20of%20poverty)%20AND%20AREA%5BOverallStatus%5D(NOT_YET_RECRUITING%20OR%20RECRUITING%20OR%20AVAILABLE)&rank=3

Development of an mHealth Behavioral Sleep Medicine ... 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 ...

3. formative.jmir.org formative.jmir.org/2024/1/e48068

Development and Evaluation of a Digital App for Patient Self ... Many patients receiving opioid agonist treatment in methadone maintenance treatment settings benefit from counseling treatments to help them ...

4. academic.oup.com academic.oup.com/sleep/article/48/Supplement_1/A542/8135678

Navigating Sleep Solutions for Persons with Opioid Use ... Initial testing of RestBest indicates high usability and positive reception among users. The findings underscore the importance of customizable ...

5. reporter.nih.gov reporter.nih.gov/search/l4YWPHKJxECbqc0gjr8UFg/project-details/10058548

NIH Project Information Development of an mHealth Behavioral Sleep Medicine Intervention for use during Medication Assisted Treatment for Opioid Use Disorder. 515, 5R34DA058511-03 ...

6. psychiatryonline.org psychiatryonline.org/doi/full/10.1176/appi.ajp.20230055

Effects of Bundling Medication for Opioid Use Disorder ... The primary outcome was abstinence from illicit opioid use; secondary outcomes were treatment retention, health services use, other substance ...