Smartphone behavioral sleep therapy for people starting buprenorphine for opioid use disorder
Development of an mHealth Behavioral Sleep Medicine Intervention for Use During Medication Assisted Treatment for Opioid Use Disorder
NA · Medical University of South Carolina · NCT06157840
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Medical University of South Carolina (other) |
| Locations | 1 site (Charleston, South Carolina) |
| Trial ID | NCT06157840 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Charleston, South Carolina
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Opioid Use Disorder, Poor Quality Sleep