Opioid Use DisorderNCT06157840
Development of an mHealth Behavioral Sleep Medicine Intervention for Use During Medication Assisted Treatment for MOUD
A study testing mHealth application and sleep health education and Simplified mHealth application and sleep health education in people with Opioid Use Disorder and Poor Quality Sleep, run by Medical University of South Carolina at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Use Disorder, Poor Quality Sleep
- What is being tested?
- mHealth application and sleep health education and Simplified mHealth application and sleep health education
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Aug 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jacelyn Lane contact
United States1 site, 1 recruiting
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29464
Allison Wilkerson, PhD, 843-792-4636, wilkersa@musc.edu
About this study
Official title: Development of an mHealth Behavioral Sleep Medicine Intervention for Use During Medication Assisted Treatment for Opioid Use Disorder
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.
Read the detailed 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.
- Conditions
- Opioid Use Disorder, Poor Quality Sleep
- Being tested
- mHealth application and sleep health education, Simplified mHealth application and sleep health education
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mHealth application and sleep health educationDevice
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 educationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Simplified mHealth application and sleep health education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: 6 weeks following enrollment
Secondary outcomes (7)
Pittsburgh Sleep Quality Index
Validated measure of difficulty falling and staying asleep and subsequent daytime function
Measured: At enrollment and 6 weeks following enrollment
Structured Clinical Interview for Sleep Disorders - Revised Edition
Assessment for sleep disorders based on the DSM-5
Measured: At enrollment and 6 weeks following enrollment
Insomnia Severity Index
Global sleep quality; the most common self-reported sleep measure
Measured: At enrollment and 6 weeks following enrollment
Daily Sleep Diary - Sleep Onset Latency
Subjective sleep onset latency (time to fall asleep)
Measured: Through study completion of 6 weeks
Daily Sleep Diary - Wake-time After Sleep
Subjective time awake after sleep onset
Measured: Through study completion of 6 weeks
Daily Sleep Diary - Total Sleep Time
Subjective total sleep time
Measured: Through study completion of 6 weeks
Daily Sleep Diary - Sleep Efficiency
Subjective sleep efficiency
Measured: Through study completion of 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2023
- Study start25 Aug 2025
- Primary completion15 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Allison K Wilkerson, Ph.D., Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06157840
- Sponsor's protocol ID
- Pro128158
- Other IDs
- 1R34DA058511
- Status last verified
- Sep 2026
- First submitted
- 6 Nov 2023
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of an mHealth Behavioral Sleep Medicine Intervention for Use During Medication Assisted Treatment for Opioid Use Disorder
- ClinicalTrials.gov ID
- NCT06157840
- Acronym / sponsor ID
- Pro128158
- Conditions
- Opioid Use Disorder, Poor Quality Sleep
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 25 Aug 2025 (actual)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 6 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mHealth application | Experimental | Device: mHealth application and sleep health educationStudy 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. |
| Control Group | Experimental | Device: Simplified mHealth application and sleep health educationParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- No experience of withdrawal symptoms in past 2 weeks
- Being stabilized on buprenorphine
- Currently experiencing clinically significant sleep disturbance (PSQI > 5)
- Able to read and understand English
- Owns an Android or iOS smartphone
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mHealth application and sleep health educationStudy 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 | Device | mHealth application |
| Simplified mHealth application and sleep health educationStudy 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. | Device | Control Group |
Primary outcome
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.
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.
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
7 secondary outcomes
Pittsburgh Sleep Quality Index
Time frame: At enrollment and 6 weeks following enrollment
Structured Clinical Interview for Sleep Disorders - Revised Edition
Time frame: At enrollment and 6 weeks following enrollment
Insomnia Severity Index
Time frame: At enrollment and 6 weeks following enrollment
Daily Sleep Diary - Sleep Onset Latency
Time frame: Through study completion of 6 weeks
Daily Sleep Diary - Wake-time After Sleep
Time frame: Through study completion of 6 weeks
Daily Sleep Diary - Total Sleep Time
Time frame: Through study completion of 6 weeks
Daily Sleep Diary - Sleep Efficiency
Time frame: Through study completion of 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jacelyn Lane contact
Allison K Wilkerson, Ph.D. principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mHealth application and sleep health education and Simplified mHealth application and sleep health education in people with Opioid Use Disorder and Poor Quality Sleep, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Allison K Willkerson, Ph.D. (843-792-4636, wilkersa@musc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enrollment feasibility/acceptability benchmark of at least 30 persons completing entire study period - Enrollment and retention percentages (time frame: 6 weeks following enrollment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.