Development of an mHealth Behavioral Sleep Medicine Intervention for Use During Medication Assisted Treatment for Opioid Use Disorder

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
South Carolina
Medical University of South Carolina
RECRUITING
Charleston
Contact Information
Primary
Allison K Willkerson, Ph.D.
wilkersa@musc.edu
843-792-4636
Backup
Jacelyn Lane
lanejac@musc.edu
Time Frame
Start Date: 2025-08-25
Estimated Completion Date: 2026-04-30
Participants
Target number of participants: 40
Treatments
Experimental: mHealth application
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.
Experimental: Control Group
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.
Related Therapeutic Areas
Sponsors
Collaborators: National Institute on Drug Abuse (NIDA)
Leads: Medical University of South Carolina

This content was sourced from clinicaltrials.gov