Smartphone behavioral sleep therapy for people starting buprenorphine for opioid use disorder
Official title: Development of an mHealth Behavioral Sleep Medicine Intervention for Use During Medication Assisted Treatment for Opioid Use Disorder
Run by Medical University of South Carolina · NCT06157840 · Data updated 2026-11-12
This project will test a smartphone app that delivers cognitive behavioral therapy for insomnia and other sleep supports for adults beginning buprenorphine for opioid use disorder who have poor sleep.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | Medical University of South Carolina Academic / other |
| Locations | 1 site (Charleston, South Carolina) |
| Status | Recruiting |
| Started | August 25, 2025 |
| Main results expected | December 15, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | September 28, 2026 |
| Trial ID | NCT06157840 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18+) who read English, own an Android or iOS smartphone, have clinically significant sleep disturbance (PSQI > 5), and have started or recently changed buprenorphine within the past three months and are currently stabilized without recent withdrawal symptoms.
✕Probably not a fit
People with current psychosis, active suicidal ideation, severe visual impairment, current benzodiazepine use, severe other substance use disorders, or peripartum women are excluded and likely would not benefit from this app-based intervention as tested.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This pilot randomized controlled trial will enroll 40 adults initiating buprenorphine for opioid use disorder who report clinically significant sleep disturbance. Participants will be randomized to either a full mHealth app delivering CBT-I plus other evidence-based sleep interventions or a simplified app offering sleep hygiene, and will complete the program over six weeks. Both groups will complete daily electronic sleep diaries and weekly brief assessments, with final online questionnaires measuring feasibility, acceptability, and insomnia severity. The primary aim is to test feasibility and acceptability and to measure preliminary changes in sleep disturbance to guide further development.
Why it matters
Potential benefit: If successful, the app could improve sleep quality during early medication treatment and make behavioral sleep therapy more accessible to people on MOUD.
How similar studies have gone: Digital CBT-I has shown benefit for insomnia in general populations and some substance-using groups, but an app specifically tailored for people initiating MOUD is relatively novel and untested.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Medical University of South Carolina
Charleston, South Carolina, United States Recruiting
Study contacts
- Principal investigator: Allison K Wilkerson, Ph.D. — Medical University of South Carolina
- Study coordinator: Allison K Willkerson, Ph.D.
- Email: wilkersa@musc.edu
- Phone: 843-792-4636
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
CBD for Opioid Dependence and Pain on Buprenorphine
This study tests whether different doses of cannabidiol (CBD) can affect pain and opioid cravings in adults with opioid use disorder who are on buprenorphine, using a short, randomized, placebo-controlled setup.
-
Cebranopadol for opioid withdrawal in adults with chronic pain
This study tests whether cebranopadol can reduce withdrawal symptoms in adults with chronic pain who are physically dependent on prescribed opioids, compared with placebo.
-
emPath platform pilot to link and keep adults with opioid use disorder in care in Durham
This pilot tests a mobile app and telemedicine approach to help adults with opioid use disorder start and stay in MOUD through community outreach in Durham, NC.
-
CB1 Receptors in Opioid Use Disorder Measured with a PET Radioligand
This study tests CB1 receptor availability in people with opioid use disorder starting opioid agonist therapy and compares them with healthy adults.
-
STORC: Training a support person plus patient navigation after birth
We’re testing whether training a designated support person and using patient navigation after delivery helps people with opioid use disorder build recovery resources and stay in treatment.
-
Personalized Addiction Treatment Enhancement for Opioid Use Disorder
A digital platform run by peer recovery supporters will be tested to help adults with opioid use disorder who are on buprenorphine or methadone stay in treatment and improve outcomes.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.