Opioid-Related DisordersNCT07665502
Pre-Pilot (R61) WINGS+++: mHealth to Improve MOUD Uptake in Women Experiencing Intimate Partner Violence and PTSD
A study testing Pre-Pilot WINGS++++ in people with Opioid-Related Disorders and Substance-Related Disorders, run by Dawn A. Goddard-Eckrich at 2 sites in United States.
Trial 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. . Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Opioid-Related Disorders, Substance-Related Disorders, Intimate Partner Violence (IPV)
- What is being tested?
- Pre-Pilot WINGS++++
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 2 sitesUnited States
- Study dates
- 21 Apr 2026to 31 Aug 2027
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Columbia University School of Social Work
New York, New York, 10027
Cornerstone
Newburgh, New York, 12550
About this study
Official title: Pre-Pilot WINGS +++ An Effectiveness Trial of Syndemic Mhealth Intervention to Increase MOUD Uptake Among Women Impacted by Intimate Partner Violence and PTSD.
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:
Read more
- Does WINGS+++ lower non-prescription opioid and other drug use in women?
- 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
Read the detailed description
The goal of this pre-pilot for the clinical trial is to develop a mobile health (mHealth) program called WINGS+++ that 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.
WINGS+++ is delivered across 3 sessions on a mobile device and combines three components into a single program: a tool that screens for physical, sexual, and emotional abuse and provides brief support and safety planning; a tool that identifies trauma-related (PTSD) symptoms and offers brief education and coping strategies; and a tool that screens for substance use concerns and helps connect women to appropriate treatment. The program also includes peer navigators, trained individuals with lived experience of substance use, intimate partner violence, or both who help connect participants to services based on their screening results and preferences.
This pre-pilot is a single-arm study in which all participants receive WINGS+++. The main goals are to assess whether the program and study procedures are feasible, acceptable to participants, and safe. Feasibility will be measured through factors such as recruitment, retention, session completion, and successful connection to referred services. Acceptability will be assessed through participant feedback, including interviews about their experience. Safety will be monitored by tracking any adverse events. Findings will be used to refine the program before later phases of the study.
- Conditions
- Opioid-Related Disorders, Substance-Related Disorders, Intimate Partner Violence (IPV), Stress Disorders, Post-Traumatic, Domestic Violence, Medication for Opioid Use Disorder (MOUD)
- Being tested
- Pre-Pilot WINGS++++
- Medical subject headings
- Opioid-Related Disorders, Substance-Related Disorders, Stress Disorders, Post-Traumatic, Combat Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-Pilot WINGS++++Behavioural
Pre-Pilot WINGS+++ Intervention (3 sessions) After completing the baseline survey, they will participate in the three-session WINGS+++ program using a tablet, computer, or smartphone. The sessions include educational videos, interactive exercises, safety planning tools, and activities designed to address intimate partner violence, trauma symptoms, and substance use. Work with a Community Health Advocate (Peer Navigator) who will help set goals and connect you to services such as MOUD treatment, harm reduction services, mental health services, and intimate partner violence services.
| Study group | Role | What they receive |
|---|---|---|
| Pre-Pilot WINGS+++ Intervention | Experimental | Participants will receive the WINGS+++ 3-session mHealth intervention with peer navigation delivered over a 30-day period. Session 1 focuses on OUD/SUD screening, brief intervention, and referral to treatment (SBIRT) and includes a 40-minute mHealth tool plus a 20-minute peer navigator check-in. Session 2 focuses on IPV SBIRT and includes a 60-minute mHealth tool plus 20 minutes of peer navigation. Session 3 focuses on PTSD SBIRT and closing activities and includes a 60-minute mHealth tool plus 20 minutes of peer navigation. WINGS+++ mHealth sessions may be delivered using tablets at study sites or participant smartphones. Participants will also receive peer navigation from Community Health Advocates with lived experience of substance use disorder and/or intimate partner violence. Receives: Behavioral: Pre-Pilot WINGS++++ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Score on the WINGS+++ Satisfaction Scale - Pre-Pilot Phase
Acceptability will be measured using a study-specific 12-item satisfaction scale administered after the intervention. Each item is rated on a 4-point Likert scale from 1 (very unsatisfied) to 4 (very satisfied). A mean score is calculated across the 12 items, ranging from 1 to 4. Higher scores indicate greater acceptability.
Measured: 1 month post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2026
- Study start21 Apr 2026
- Primary completion27 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid-Related DisordersStudies 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The R61 pre-pilot phase is a single-arm pilot trial evaluating the feasibility, acceptability, and safety of WINGS+++ and assessing pre- to post-intervention changes in primary and secondary outcomes. 7 women with opioid use disorder or other substance use disorder who have experienced intimate partner violence in the past year will be enrolled from two harm reduction programs in Orange County, New York. All participants receive WINGS+++, a 3-session mHealth intervention integrating an IPV screening, brief intervention, and referral (SBIRT) tool, a novel PTSD SBIRT tool, and an OUD/SUD SBIRT with a service linkage platform (NYMatters), delivered alongside peer navigation. Assessments occur at baseline and 1-months post-intervention. Findings will inform refinement of WINGS+++ and the implementation infrastructure for the R61 pilot phase and the subsequent R33 effectiveness trial.
- Masking
- None (open label)
- Enrolment
- 7 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dawn A. Goddard-Eckrich
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), City University of New York, University of Pennsylvania
- Responsible party
- Sponsor-investigator, Dawn A. Goddard-Eckrich, Columbia University
- Investigators
- Louisa Gilbert, PhD, Study chair, Columbia UniversityNabila El-Bassel, PhD, Study chair, Columbia UniversityDawn A Goddard-Eckrich, EdD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07665502
- Sponsor's protocol ID
- AAAV9733
- Other IDs
- 1R61DA061375-01A1
- Status last verified
- Jun 2026
- First submitted
- 14 May 2026
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-Pilot WINGS +++ An Effectiveness Trial of Syndemic Mhealth Intervention to Increase MOUD Uptake Among Women Impacted by Intimate Partner Violence and PTSD.
- ClinicalTrials.gov ID
- NCT07665502
- Acronym / sponsor ID
- AAAV9733
- Conditions
- Opioid-Related Disorders, Substance-Related Disorders, Intimate Partner Violence (IPV), Stress Disorders, Post-Traumatic, Domestic Violence, Medication for Opioid Use Disorder (MOUD)
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 7 participants (estimated)
- Lead sponsor
- Dawn A. Goddard-EckrichUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), City University of New York, University of Pennsylvania
- Study start
- 21 Apr 2026 (actual)
- Primary completion
- 27 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 24 Jun 2026 (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.
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:
- Does WINGS+++ lower non-prescription opioid and other drug use in women?
- 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
Detailed description
The goal of this pre-pilot for the clinical trial is to develop a mobile health (mHealth) program called WINGS+++ that 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.
WINGS+++ is delivered across 3 sessions on a mobile device and combines three components into a single program: a tool that screens for physical, sexual, and emotional abuse and provides brief support and safety planning; a tool that identifies trauma-related (PTSD) symptoms and offers brief education and coping strategies; and a tool that screens for substance use concerns and helps connect women to appropriate treatment. The program also includes peer navigators, trained individuals with lived experience of substance use, intimate partner violence, or both who help connect participants to services based on their screening results and preferences.
This pre-pilot is a single-arm study in which all participants receive WINGS+++. The main goals are to assess whether the program and study procedures are feasible, acceptable to participants, and safe. Feasibility will be measured through factors such as recruitment, retention, session completion, and successful connection to referred services. Acceptability will be assessed through participant feedback, including interviews about their experience. Safety will be monitored by tracking any adverse events. Findings will be used to refine the program before later phases of the study.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The R61 pre-pilot phase is a single-arm pilot trial evaluating the feasibility, acceptability, and safety of WINGS+++ and assessing pre- to post-intervention changes in primary and secondary outcomes. 7 women with opioid use disorder or other substance use disorder who have experienced intimate partner violence in the past year will be enrolled from two harm reduction programs in Orange County, New York. All participants receive WINGS+++, a 3-session mHealth intervention integrating an IPV screening, brief intervention, and referral (SBIRT) tool, a novel PTSD SBIRT tool, and an OUD/SUD SBIRT with a service linkage platform (NYMatters), delivered alongside peer navigation. Assessments occur at baseline and 1-months post-intervention. Findings will inform refinement of WINGS+++ and the implementation infrastructure for the R61 pilot phase and the subsequent R33 effectiveness trial.
| Arm | Type | Receives |
|---|---|---|
| Pre-Pilot WINGS+++ Intervention | Experimental | Behavioral: Pre-Pilot WINGS++++Participants will receive the WINGS+++ 3-session mHealth intervention with peer navigation delivered over a 30-day period. Session 1 focuses on OUD/SUD screening, brief intervention, and referral to treatment (SBIRT) and includes a 40-minute mHealth tool plus a 20-minute peer navigator check-in. Session 2 focuses on IPV SBIRT and includes a 60-minute mHealth tool plus 20 minutes of peer navigation. Session 3 focuses on PTSD SBIRT and closing activities and includes a 60-minute mHealth tool plus 20 minutes of peer navigation. WINGS+++ mHealth sessions may be delivered using tablets at study sites or participant smartphones. Participants will also receive peer navigation from Community Health Advocates with lived experience of substance use disorder and/or intimate partner violence. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
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 |
|---|---|---|
| Pre-Pilot WINGS++++Pre-Pilot WINGS+++ Intervention (3 sessions) After completing the baseline survey, they will participate in the three-session WINGS+++ program using a tablet, computer, or smartphone. The sessions include educational videos, interactive exercises, safety planning tools, and activities designed to address intimate partner violence, trauma symptoms, and substance use. Work with a Community Health Advocate (Peer Navigator) who will help set goals and connect you to services such as MOUD treatment, harm reduction services, mental health services, and intimate partner violence services. | Behavioural | Pre-Pilot WINGS+++ Intervention |
Primary outcome
Mean Score on the WINGS+++ Satisfaction Scale - Pre-Pilot Phase
Time frame: 1 month post-intervention
Acceptability will be measured using a study-specific 12-item satisfaction scale administered after the intervention. Each item is rated on a 4-point Likert scale from 1 (very unsatisfied) to 4 (very satisfied). A mean score is calculated across the 12 items, ranging from 1 to 4. Higher scores indicate greater acceptability.
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 Jul 2026.
- Individual participant dataSharing planned: Undecided
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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.
Louisa Gilbert, PhD study chair
Columbia University
Nabila El-Bassel, PhD study chair
Columbia University
Dawn A Goddard-Eckrich, EdD principal investigator
Columbia University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pre-Pilot WINGS++++ in people with Opioid-Related Disorders and Substance-Related Disorders, run by Dawn A. Goddard-Eckrich at 2 sites 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 5 inclusion and 2 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: enrolling by invitation, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Score on the WINGS+++ Satisfaction Scale - Pre-Pilot Phase (time frame: 1 month post-intervention). 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 Jul 2026.