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NCT Number: NCT06157840

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

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.

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Key information

Conditions

Opioid Use Disorder Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Poor Quality Sleep Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29464, United States

Location status: Recruiting

Location contact

Allison Wilkerson, PhD

CONTACT

[email protected]

8437924636

About this study

This pilot randomized controlled trial will assess the feasibility and acceptability of an evidence-based behavioral sleep intervention delivered via a mHealth app to individuals initiating treatment with medications for opioid use disorder. Additional outcomes include changes in sleep disturbance over the course of the 6-week intervention. Participants (N=40, 20 per group) will be randomized to download the mHealth app to their smartphones and complete the intervention within 6 weeks. The control group will receive a simplified version of the app with sleep hygiene instructions. Both groups will 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. At the end of the 6th week, they will complete an online series of questionnaires, including validated feasibility/acceptability measures and measures of insomnia severity.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

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

Treatment and study plan

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

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.

Primary outcomes

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

    Time frame: 6 weeks following enrollment

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

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

    Time frame: 6 weeks following enrollment

    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.

  3. mHealth App Usability Questionnaire

    Time frame: 6 weeks following enrollment

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

Secondary outcomes

  1. Pittsburgh Sleep Quality Index

    Time frame: At enrollment and 6 weeks following enrollment

    Validated measure of difficulty falling and staying asleep and subsequent daytime function

  2. Structured Clinical Interview for Sleep Disorders - Revised Edition

    Time frame: At enrollment and 6 weeks following enrollment

    Assessment for sleep disorders based on the DSM-5

  3. Insomnia Severity Index

    Time frame: At enrollment and 6 weeks following enrollment

    Global sleep quality; the most common self-reported sleep measure

  4. Daily Sleep Diary - Sleep Onset Latency

    Time frame: Through study completion of 6 weeks

    Subjective sleep onset latency (time to fall asleep)

  5. Daily Sleep Diary - Wake-time After Sleep

    Time frame: Through study completion of 6 weeks

    Subjective time awake after sleep onset

  6. Daily Sleep Diary - Total Sleep Time

    Time frame: Through study completion of 6 weeks

    Subjective total sleep time

  7. Daily Sleep Diary - Sleep Efficiency

    Time frame: Through study completion of 6 weeks

    Subjective sleep efficiency

Other outcomes

  1. MOUD and drug use

    Time frame: Through study completion of 6 weeks

    Self-reported checklist

Study contacts

Contact information is provided by the study sponsor or research team.

Allison K Willkerson, Ph.D.

CONTACT

[email protected]

843-792-4636

Jacelyn Lane

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 6, 2023
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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