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

Opioid Use Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06157840
• Other study ID #: Pro128158
• Secondary ID: 1R34DA058511
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 1, 2025
• Est. completion date: May 1, 2026

Study information

• Verified date: March 2024
• Source: Medical University of South Carolina
• Contact: Allison K Willkerson, Ph.D.
• Phone: 843-792-4636
• Email: wilkersa[@]musc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: May 1, 2026
• Est. primary completion date: February 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Opioid Use Disorder
• Opioid-Related Disorders
• Poor Quality Sleep

Intervention

Device:
• mHealth application and sleep health education
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
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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of South Carolina	National Institute on Drug Abuse (NIDA)

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	MOUD and drug use	Self-reported checklist	Through study completion of 6 weeks
Primary	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
Primary	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
Primary	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	Pittsburgh Sleep Quality Index	Validated measure of difficulty falling and staying asleep and subsequent daytime function	At enrollment and 6 weeks following enrollment
Secondary	Structured Clinical Interview for Sleep Disorders - Revised Edition	Assessment for sleep disorders based on the DSM-5	At enrollment and 6 weeks following enrollment
Secondary	Insomnia Severity Index	Global sleep quality; the most common self-reported sleep measure	At enrollment and 6 weeks following enrollment
Secondary	Daily Sleep Diary - Sleep Onset Latency	Subjective sleep onset latency (time to fall asleep)	Through study completion of 6 weeks
Secondary	Daily Sleep Diary - Wake-time After Sleep	Subjective time awake after sleep onset	Through study completion of 6 weeks
Secondary	Daily Sleep Diary - Total Sleep Time	Subjective total sleep time	Through study completion of 6 weeks
Secondary	Daily Sleep Diary - Sleep Efficiency	Subjective sleep efficiency	Through study completion of 6 weeks