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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
First received
Last updated
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
Health authority
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

Study Design


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
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