Pre-Pilot (R61) WINGS+++: mHealth to Improve MOUD Uptake in Women Experiencing Intimate Partner V… (NCT07665502) | Clinical Trial Compass
By InvitationNot Applicable
Pre-Pilot (R61) WINGS+++: mHealth to Improve MOUD Uptake in Women Experiencing Intimate Partner Violence and PTSD
United States7 participantsStarted 2026-04-21
Plain-language summary
The goal of this pre-pilot for the clinical trial is to develop a mobile health (mHealth) program called WINGS+++ can help women with opioid use disorder or other substance use disorders who have experienced intimate partner violence. The pre-pilot study will take place in Orange County, New York with n=7 women. .
The main questions it aims to answer are:
1. Does WINGS+++ lower non-prescription opioid and other drug use in women?
2. Does WINGS+++ help connect women to treatment for substance use, intimate partner violence, and post-traumatic stress disorder (PTSD)?
Researchers will compare WINGS+++ to standard care to see if WINGS+++ works better to lower drug use and link women to helpful services.
WINGS+++ is a 3-session program on a mobile device that:
* Screens for intimate partner violence, PTSD, and substance use
* Offers brief support and referrals based on each woman's needs and preferences
* Connects women to a peer navigator who helps link them to services
Participants will:
* Take part in only the WINGS+++ program for the pre-pilot
* Answer survey questions about drug use, intimate partner violence, and PTSD symptoms
* Provide biological samples (such as urine or hair) to check for drug use
* Share information about the services they have used
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Identify as a woman (cisgender or transgender)
* Aged 18 or older
* Report use of non-prescribed opioids in the past 30 days
* Score positive for risk of opioid use disorder or other substance use disorder on the Drug Abuse Screening Test (DAST) with a cut-off score of 6 or higher
* Report experiencing any severe psychological abuse or any physical or sexual abuse by a female or male intimate partner in the past year.
Exclusion Criteria:
* Evidence of significant psychiatric or cognitive impairment that would limit effective participation, as confirmed during informed consent;
* Inability to speak and understand English sufficiently to participate in assessments or intervention sessions.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Mean Score on the WINGS+++ Satisfaction Scale - Pre-Pilot Phase