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

NCT06157840 | Recruiting

• 2 other identifiers: Pro1281581R34DA058511
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Poor Quality Sleep; Opioid Use Disorder

Outcome Measures

Primary Outcomes (3)

• Enrollment feasibility/acceptability benchmark of at least 30 persons completing entire study period - Enrollment and retention percentages

  To achieve a minimum enrollment and retention percentage of 75% throughout the 6-week investigation period.

  6 weeks following enrollment

• Protocol adherence feasibility/acceptability benchmarks of participants completing modules and sleep diaries each week - Engagement

  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.

  6 weeks following enrollment

• mHealth App Usability Questionnaire

  Validated measure of mobile app usability with 3 sections: Ease of use/satisfaction, system information arrangement, and usefulness

  6 weeks following enrollment

Secondary Outcomes (7)

• Pittsburgh Sleep Quality Index

  At enrollment and 6 weeks following enrollment

• Structured Clinical Interview for Sleep Disorders - Revised Edition

  At enrollment and 6 weeks following enrollment

• Insomnia Severity Index

  At enrollment and 6 weeks following enrollment

• Daily Sleep Diary - Sleep Onset Latency

  Through study completion of 6 weeks

• Daily Sleep Diary - Wake-time After Sleep

  Through study completion of 6 weeks

Other Outcomes (1)

• MOUD and drug use

  Through study completion of 6 weeks

Study Arms (2)

mHealth application

EXPERIMENTAL

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.

Device: mHealth application and sleep health education

Control Group

EXPERIMENTAL

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.

Device: Simplified mHealth application and sleep health education

Interventions

mHealth application and sleep health education DEVICE

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

mHealth application

Simplified mHealth application and sleep health education DEVICE

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.

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of South Carolina: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29464, United States

RECRUITING

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Allison K Wilkerson, Ph.D.

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Allison K Willkerson, Ph.D.

CONTACT

843-792-4636; wilkersa@musc.edu

Jacelyn Lane

CONTACT

lanejac@musc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 6, 2023
• First Posted: December 6, 2023
• Study Start: August 25, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): July 17, 2026
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)