Opioid Use DisorderNCT06999811
Technology-Enhanced Therapy vs. Medication Monitoring for Buprenorphine Retention in Pregnant Persons
A study testing Empowering Pregnant Women and People Receiving medications for opioid use disorder (EMPWR) in people with Opioid Use Disorder and Pregnancy, run by Medical University of South Carolina at 1 site in United States.
Trial summary
This study involves testing how useful a technology-enhanced therapy is for pregnant people prescribed buprenorphine for the treatment of opioid use disorder, compared to medication monitoring. Participants are randomized to one of the conditions. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Opioid Use Disorder, Pregnancy
- What is being tested?
- Empowering Pregnant Women and People Receiving medications for opioid use disorder (EMPWR)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Nov 2025to 15 Oct 2028
- Phase
- Interventional
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 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- currently pregnant and between 13 weeks and 0 days to 32 weeks and 6 days gestational age
- current OUD or history of OUD within past 3 years
- confirmed prescription for sublingual buprenorphine products (i.e., Suboxone, Subutex, Zubsolv) for the purpose of treating OUD
- living in the United States
- between 18-45 years of age
Who cannot join
- carrying multiples
- high-risk pregnancies including the following conditions: active hyperemesis at the time of consent or hospitalization for intractable nausea and vomiting in the current pregnancy, hypertensive disorders of pregnancy (e.g., gestational hypertension, preeclampsia), placenta previa, or vaginal bleeding in current pregnancy after the first trimester
- current psychotic symptoms and/or active suicidal intent
- experiencing cognitive or emotional impairment that precludes providing informed consent
- incarcerated/pending incarceration or institutionalized during the study period
- non-English speaking.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29403
Morgan Thomas, 843-998-4211, thomamor@musc.edu
Sara M Witcraft, PhD
About this study
This study involves testing how useful a technology-enhanced therapy is for pregnant people prescribed buprenorphine for the treatment of opioid use disorder, compared to medication monitoring. Participants are randomized to one of the conditions. If participants are randomized to receive the therapy, participants will attend four 60-minute therapy appointments during pregnancy with an additional 30-minute therapy session towards the end of pregnancy, and 6 additional monthly postpartum (after childbirth) sessions (0-6 months postpartum). As part of the therapy program, participants will receive access to a mobile application, which will be accessible for the duration of the study. If participants are randomized to medication monitoring, participants will be asked to log each time participants take their medication for two months. All participants will also be asked to complete questionnaires at enrollment and again at 3-month postpartum and 6-months postpartum, and will be contacted randomly throughout the study to perform a medication count. The total duration of the study is between 8-12 months depending on when participants enroll (early second trimester-mid third trimester).
Read the detailed description
Medication for opioid use disorder (MOUD) can effectively prevent overdose and death for pregnant and postpartum people with opioid use disorder (OUD). Yet, only half of birthing people continue to use MOUD postpartum, increasing risk for overdose two-fold. This study will evaluate feasibility of RCT methodology for a technology-enhanced behavioral intervention that aims to improve retention in and adherence to MOUD during the peripartum period compared to control (medication monitoring). The intervention contains a brief behavioral intervention targeting malleable risk factors for treatment dropout, opioid cravings, and return to illicit opioid use: anxiety sensitivity and sleep deficiency. An adjunctive mobile application will supplement therapy sessions and contains a medication adherence feature involving daily (or multiple/day) notification reminder to take medication at a scheduled time and dose consistent with the participant's prescription. This study is supported by funding from the NIH HEAL Initiative (https://heal.nih.gov/).
- Conditions
- Opioid Use Disorder, Pregnancy
- Being tested
- Empowering Pregnant Women and People Receiving medications for opioid use disorder (EMPWR), Medication monitoring (control)
- Keywords
- Anxiety, Mental Health, Pregnancy, Psychiatry, Sleep Disorders, Substance Use, Women's Health
- Medical subject headings
- Opioid-Related Disorders, Anxiety Disorders, Psychological Well-Being, Sleep Wake Disorders, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Empowering Pregnant Women and People Receiving medications for opioid use disorder (EMPWR)Behavioural
EMPWR is evidence-informed, behavioral intervention to address risk factors for fear of opioid withdrawal, craving, and stress, with an adjective mobile application among pregnant women receiving opioid agonist therapies. The goal of EMPWR is to promote medication retention and adherence.
Medication monitoring (control)Other
Participants will record the dose and time buprenorphine was taken for two months via REDCap daily diaries, which will be delivered via text.
| Study group | Role | What they receive |
|---|---|---|
| EMPWR | Experimental | Brief cognitive-behavioral intervention and mobile application Receives: Behavioral: Empowering Pregnant Women and People Receiving medications for opioid use disorder (EMPWR) |
| Control | Active comparator | medication monitoring Receives: Other: Medication monitoring (control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Recruitment
Recruitment will be assessed by the proportion of participants who agree to participate in the trial vs. total approached; success is if ≥70% of approached PPP enroll.
Measured: Years 3-4
Retention in Active Treatment (EMPWR)
Retention will be assessed by the proportion of participants who complete 3- and 6-month postpartum follow-up assessments vs. those who prematurely terminate; success is if 70% of participants are retained for follow-up assessments.
Measured: Years 3-4
Engagement in intervention
Overall engagement will be measured separately for the EMPWR behavioral intervention and mobile application (EMPWR condition) and daily diary completion (MM condition). To measure engagement in the EMPWR condition, we will consider it successful if 70% of participants attend all EMPWR behavioral intervention sessions, and separately, actively engage with the active components of the mobile application (i.e., 50% days logged buprenorphine, 50% assigned at-home "Practice" exercises completed). In the MM condition, we will consider completing 70% of daily diaries as successful engagement.
Measured: Years 3-4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2025
- Study start5 Nov 2025
- Primary completion15 Oct 2028 (estimated)
- Study completion15 Oct 2028 (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.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 37 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
- Principal investigator, Sara Witcraft, Medical University of South Carolina
- Investigators
- Sara Witcraft, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06999811
- Sponsor's protocol ID
- Pro00141060
- Other IDs
- 1K23DA062794-01
- Status last verified
- Nov 2025
- First submitted
- 15 May 2025
- Last updated
- 8 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No