Opioid Use DisorderSTRONGERNCT07115030
Project STRONGER: Stepped Care for Opioid Use Disorder Treatment Engagement and Recovery
A study testing PCT+2HOPE in people with Opioid Use Disorder and Intimate Partner Violence (IPV), run by Yale University at 3 sites in United States.
Trial summary
Using a hybrid type 1 effectiveness-implementation approach, this study aims to evaluate the impact of a novel stepped care model ("PCT+2HOPE") versus treatment as usual (TAU) on increasing retention in community-based medication for opioid use disorder (MOUD) treatment among women who have experienced intimate… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Opioid Use Disorder, Intimate Partner Violence (IPV), Post Traumatic Stress Disorder PTSD
- What is being tested?
- PCT+2HOPE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 532 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Jun 2026to 31 Aug 2029
- 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
- Woman;
- Are ≥ 18 years old;
- Receive MOUD treatment at one of the participating sites;
- Have received MOUD for >14 days to allow for initial stabilization;
- Have initiated the current treatment episode within the past 12 months;
- Experienced physical or psychological IPV in their lifetime;
Show all 10Show fewer
- Have at least moderate impairment in psychosocial functioning (on B-IPF) as a result of PTSD symptoms;
- Available during the date/time of the intervention group
- Able to read/understand English; and
- Provide written informed consent.
Who cannot join
- Fail a capacity-to-consent questionnaire;
- Have an unstable medical condition (e.g., hospitalization, planned surgery, newly starting chemotherapy, plans for palliative care) and/or unstable psychiatric illness (e.g., untreated psychosis) that would interfere with their ability to participate in study activities;
- Will be unavailable for >4 consecutive weeks during the study period (e.g., anticipated move, planned surgery);
- Are unable to read/understand English;
- Inability to provide at least one form of contact
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Liberation Programs
Bridgeport, Connecticut, 06610
Joanne Montgomery, LCSW, LADC, 203-953-3347, Joanne.Montgomery@liberationprograms.org
- Not yet recruiting
Community Health Resources (CHR) Pathways Opiate Treatment Program
Enfield, Connecticut, 06082
Kate Battista, CAC, LPC, 860-835-7415, kbattista@chrhealth.org
- Recruiting
The APT Foundation, Inc.
West Haven, Connecticut, 06516
Lynn Madden, PhD, MPA, 203-781-4600, lmadden@aptfoundation.org
About this study
Using a hybrid type 1 effectiveness-implementation approach, this study aims to evaluate the impact of a novel stepped care model ("PCT+2HOPE") versus treatment as usual (TAU) on increasing retention in community-based medication for opioid use disorder (MOUD) treatment among women who have experienced intimate partner violence (W-IPV). PCT+2HOPE includes Present-Centered Therapy (PCT+) with stepped care as indicated by moderate, severe, or extreme PTSD-related impairment in psychosocial functioning to Helping to Overcome PTSD through Empowerment (HOPE), two evidence-based behavioral interventions adapted for women with opioid use disorder (OUD). We will examine the effectiveness of PCT+2HOPE vs. TAU on the primary outcome (i.e., retention in MOUD treatment) and secondary outcomes related to trauma (i.e., PTSD-related impairment in psychosocial functioning and depression), substance use (i.e. OUD symptom severity, extra-medical opioid use [i.e., use of prescription opioids without a doctor's prescription; in greater amounts, more often, longer than prescribed, or for a reason other than a doctor said they should be used], and recovery), and empowerment. We will explore the extent to which the effectiveness of PCT+2HOPE vs. treatment as usual differs based on access to basic needs. We will also conduct an implementation-focused process evaluation.
- Being tested
- PCT+2HOPE
- Keywords
- opioid use disorder, intimate partner violence, domestic violence
- Medical subject headings
- Opioid-Related Disorders, Combat Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCT+2HOPEBehavioural
Each PCT+ group follows the same structure and starts with the group setting an agenda. Clients identify issues to work on using these steps: 1) Identify an issue and if/how it relates to their PTSD or substance use, 2) Brainstorm ideas that may help, 3) Evaluate how useful each idea is, and 4) Choose a plan. Clients are encouraged to implement and evaluate the effectiveness of the plan and share the outcome at their next group. At the end of the group, clients process their experiences of the discussion.
HOPE is a flexible, module-based individual treatment where the ordering and emphasis of each module are determined by client priorities. HOPE is trauma-focused; clients relate their current symptoms to their experience of IPV, but do not process traumatic memories. Modules focus on 1) Establishing safety, providing information and skills that enhance empowerment, 2) Cognitive behavioral therapy skills, and 3) Improving relationships and establishing healthy boundaries.
| Study group | Role | What they receive |
|---|---|---|
| PCT+2HOPE | Experimental | During the first 12 weeks, participants will be offered PCT+ via eight 1-hour group sessions facilitated by a trained counselor ("facilitator") at the treatment program where they receive MOUD. The purpose of this group is to help participants address problems in their daily lives that arise from PTSD-related impairment in psychosocial functioning. After 12 weeks, participants who meet any of the following criteria will be "stepped up" to HOPE: 1) are not retained in MOUD treatment or 2) have moderate or higher impairment in PTSD-related psychosocial functioning. Participants who are "stepped up" will be offered 10 1-hour individual sessions over the next 14 weeks. HOPE is an individual counseling program designed for women in treatment for their opioid use, who have experienced abuse from an intimate partner and are experiencing PTSD-related impairment in psychosocial functioning. Receives: Behavioral: PCT+2HOPE |
| Treatment as Usual | No intervention | Participants will be provided with a list of community resources and a referral to a local domestic violence service provider that can help address experiences of relationship strain with an intimate or romantic partner. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention in MOUD treatment
Retention in MOUD treatment at week 26. This will be measured through a combination of self-report with objective confirmation (e.g., via electronic health record, provider-confirmed treatment engagement/retention, medication bottles, urine toxicology testing).
Measured: Week 26
Secondary outcomes (7)
PTSD-related impairment in psychosocial functioning
The Brief-Inventory of Psychosocial Functioning (B-IPF) will be collected to assess PTSD-related impairment in functioning. The PCL-5 will be administered immediately prior and B-IPF items will be anchored to endorsed PTSD). B-IPF total scores represent an index of overall functional impairment, with higher scores indicating greater functional impairment.
Measured: Week 26
Opioid use disorder symptom severity
Past 30-day opioid use disorder (OUD) symptom severity will be assessed with the Opioid Use Disorder Checklist, an 11-item assessment of DSM-5 criteria. DSM-5 considers 2 to 3 criteria mild; 4 to 5, moderate; and 6 to 11, severe OUD.
Measured: Week 26
Days of extra-medical opioid use, past 30 days
Past 30-day opioid use will be assessed with the timeline follow back (TLFB) method to capture the number of days of extra-medical opioid use.
Measured: Week 26
Urine test positive for opioid use
Urine toxicology testing will be performed to assess for the presence of extra-medical opioid use (e.g., opiates, oxycodone, fentanyl).
Measured: Week 26
Depression symptom severity
The 9-item Patient Health Questionnaire (PHQ-9) will be collected to measure the prevalence and severity of the 9 DSM criteria for depression. The PHQ-9 uses a continuous score with higher scores indicating greater depression symptom severity and a 5-point change indicating clinically significant change.
Measured: Week 26
Recovery
The Response to Addiction Recovery (R2AR) will be collected to measure recovery. The R2AR is a 19-item assessment that measures recovery from a patient-centered perspective.
Measured: Week 26
Empowerment
The Personal Progress Scale-Revised (PPS-R) will be collected to measure empowerment. The PPS-R uses a continuous score with higher scores indicating higher empowerment.
Measured: Week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study start1 Jun 2026
- Primary completion31 Aug 2029 (estimated)
- Study completion31 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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
- 532 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Tami Sullivan, PhD, Principal investigator, Yale UniversityE. Jennifer Edelman, MD, MHS, AAHIVS, Principal investigator, Yale UniversityDawn Johnson, PhD, Principal investigator, The University of Akron
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07115030
- Sponsor's protocol ID
- 2000040103
- Other IDs
- R33DA059895
- Acronym
- STRONGER
- Status last verified
- Jul 2026
- First submitted
- 4 Aug 2025
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified study data and associated documentation will be made available to the research community free of charge through the Inter-university Consortium for Political and Social Research (ICPSR), which has been approved as a HEAL-compliant data repository.
Publications
Johnson DM, Zlotnick C, Gonzalez A. Treatment of Post-traumatic Stress Disorder in Survivors of Intimate Partner Violence. Handbook of Interpersonal Violence and Abuse Across the Lifespan: A project of the National Partnership to End Interpersonal Violence Across the Lifespan (NPEIV). 2021:3223-3246.
Moullin JC, Dickson KS, Stadnick NA, Rabin B, Aarons GA. Systematic review of the Exploration, Preparation, Implementation, Sustainment (EPIS) framework. Implement Sci. 2019 Jan 5;14(1):1. doi: 10.1186/s13012-018-0842-6.
PubMed 30611302Morse AK, Sercombe J, Askovic M, Fisher A, Marel C, Chatterton ML, Kay-Lambkin F, Barrett E, Sunderland M, Harvey L, Peach N, Teesson M, Mills KL. Systematic review of the efficacy, effectiveness, and cost-effectiveness of stepped-care interventions for the prevention and treatment of problematic substance use. J Subst Abuse Treat. 2023 Jan;144:108928. doi: 10.1016/j.jsat.2022.108928. Epub 2022 Nov 4.
PubMed 36370469Carroll KM, Weiss RD. The Role of Behavioral Interventions in Buprenorphine Maintenance Treatment: A Review. Focus (Am Psychiatr Publ). 2019 Apr;17(2):183-192. doi: 10.1176/appi.focus.17206. Epub 2019 Apr 10.
PubMed 32021588Johnson DM, Johnson NL, Perez SK, Palmieri PA, Zlotnick C. Comparison of Adding Treatment of PTSD During and After Shelter Stay to Standard Care in Residents of Battered Women's Shelters: Results of a Randomized Clinical Trial. J Trauma Stress. 2016 Aug;29(4):365-73. doi: 10.1002/jts.22117. Epub 2016 Jul 26.
PubMed 27459503Johnson DM, Palmieri PA, Zlotnick C, Johnson NL, Hoffman L, Holmes SC, Ceroni TL. A Randomized Controlled Trial Comparing HOPE Treatment and Present-Centered Therapy in Women Residing in Shelter with PTSD from Intimate Partner Violence. Psychol Women Q. 2020 Dec 1;44(4):539-553. doi: 10.1177/0361684320953120. Epub 2020 Sep 17.
PubMed 34305273Schnurr PP, Friedman MJ, Engel CC, Foa EB, Shea MT, Chow BK, Resick PA, Thurston V, Orsillo SM, Haug R, Turner C, Bernardy N. Cognitive behavioral therapy for posttraumatic stress disorder in women: a randomized controlled trial. JAMA. 2007 Feb 28;297(8):820-30. doi: 10.1001/jama.297.8.820.
PubMed 17327524Belsher BE, Beech E, Evatt D, Smolenski DJ, Shea MT, Otto JL, Rosen CS, Schnurr PP. Present-centered therapy (PCT) for post-traumatic stress disorder (PTSD) in adults. Cochrane Database Syst Rev. 2019 Nov 18;2019(11):CD012898. doi: 10.1002/14651858.CD012898.pub2.
PubMed 31742672Butner JL, Gupta N, Fabian C, Henry S, Shi JM, Tetrault JM. Onsite treatment of HCV infection with direct acting antivirals within an opioid treatment program. J Subst Abuse Treat. 2017 Apr;75:49-53. doi: 10.1016/j.jsat.2016.12.014. Epub 2017 Jan 24.
PubMed 28237054Ngo BV, James JR, Blalock KL, Jackson SL, Chew LD, Tsui JI. Hepatitis C treatment outcomes among patients treated in co-located primary care and addiction treatment settings. J Subst Abuse Treat. 2021 Dec;131:108438. doi: 10.1016/j.jsat.2021.108438. Epub 2021 Apr 29.
PubMed 34098298Oldfield BJ, Munoz N, McGovern MP, Funaro M, Villanueva M, Tetrault JM, Edelman EJ. Integration of care for HIV and opioid use disorder. AIDS. 2019 Apr 1;33(5):873-884. doi: 10.1097/QAD.0000000000002125.
PubMed 30882491Bailey K, Trevillion K, Gilchrist G. What works for whom and why: A narrative systematic review of interventions for reducing post-traumatic stress disorder and problematic substance use among women with experiences of interpersonal violence. J Subst Abuse Treat. 2019 Apr;99:88-103. doi: 10.1016/j.jsat.2018.12.007. Epub 2018 Dec 24.
PubMed 30797400Sullivan TP, Armeli S, Tennen H, Weiss NH, Hansen NB. Fluctuations in daily PTSD symptoms are related to proximal alcohol use: a micro-longitudinal study of women victims of intimate partner violence. Am J Drug Alcohol Abuse. 2020;46(1):98-108. doi: 10.1080/00952990.2019.1624765. Epub 2019 Jul 16.
PubMed 31311330Sullivan TP, Cavanaugh CE, Buckner JD, Edmondson D. Testing posttraumatic stress as a mediator of physical, sexual, and psychological intimate partner violence and substance problems among women. J Trauma Stress. 2009 Dec;22(6):575-84. doi: 10.1002/jts.20474.
PubMed 19960546Hellmuth JC, Jaquier V, Swan SC, Sullivan TP. Elucidating posttraumatic stress symptom profiles and their correlates among women experiencing bidirectional intimate partner violence. J Clin Psychol. 2014 Oct;70(10):1008-21. doi: 10.1002/jclp.22100. Epub 2014 Apr 19.
PubMed 24752965
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project STRONGER: Stepped Care for Opioid Use Disorder Treatment Engagement and Recovery
- ClinicalTrials.gov ID
- NCT07115030
- Acronym / sponsor ID
- STRONGER / 2000040103
- Keywords
- opioid use disorder, intimate partner violence, domestic violence
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 532 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 31 Aug 2029 (estimated)
- Study completion
- 31 Aug 2029 (estimated)
- First posted
- 11 Aug 2025 (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.
Using a hybrid type 1 effectiveness-implementation approach, this study aims to evaluate the impact of a novel stepped care model ("PCT+2HOPE") versus treatment as usual (TAU) on increasing retention in community-based medication for opioid use disorder (MOUD) treatment among women who have experienced intimate partner violence (W-IPV). PCT+2HOPE includes Present-Centered Therapy (PCT+) with stepped care as indicated by moderate, severe, or extreme PTSD-related impairment in psychosocial functioning to Helping to Overcome PTSD through Empowerment (HOPE), two evidence-based behavioral interventions adapted for women with opioid use disorder (OUD). We will examine the effectiveness of PCT+2HOPE vs. TAU on the primary outcome (i.e., retention in MOUD treatment) and secondary outcomes related to trauma (i.e., PTSD-related impairment in psychosocial functioning and depression), substance use (i.e. OUD symptom severity, extra-medical opioid use [i.e., use of prescription opioids without a doctor's prescription; in greater amounts, more often, longer than prescribed, or for a reason other than a doctor said they should be used], and recovery), and empowerment. We will explore the extent to which the effectiveness of PCT+2HOPE vs. treatment as usual differs based on access to basic needs. We will also conduct an implementation-focused process evaluation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PCT+2HOPE | Experimental | Behavioral: PCT+2HOPEDuring the first 12 weeks, participants will be offered PCT+ via eight 1-hour group sessions facilitated by a trained counselor ("facilitator") at the treatment program where they receive MOUD. The purpose of this group is to help participants address problems in their daily lives that arise from PTSD-related impairment in psychosocial functioning. After 12 weeks, participants who meet any of the following criteria will be "stepped up" to HOPE: 1) are not retained in MOUD treatment or 2) have moderate or higher impairment in PTSD-related psychosocial functioning. Participants who are "stepped up" will be offered 10 1-hour individual sessions over the next 14 weeks. HOPE is an individual counseling program designed for women in treatment for their opioid use, who have experienced abuse from an intimate partner and are experiencing PTSD-related impairment in psychosocial functioning. |
| Treatment as Usual | No intervention | –Participants will be provided with a list of community resources and a referral to a local domestic violence service provider that can help address experiences of relationship strain with an intimate or romantic partner. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Woman;
- Are ≥ 18 years old;
- Receive MOUD treatment at one of the participating sites;
- Have received MOUD for >14 days to allow for initial stabilization;
- Have initiated the current treatment episode within the past 12 months;
Key exclusion criteria (5 listed)
- Fail a capacity-to-consent questionnaire;
- Have an unstable medical condition (e.g., hospitalization, planned surgery, newly starting chemotherapy, plans for palliative care) and/or unstable psychiatric illness (e.g., untreated psychosis) that would interfere with their ability to participate in study activities;
- Will be unavailable for >4 consecutive weeks during the study period (e.g., anticipated move, planned surgery);
- Are unable to read/understand English;
- Inability to provide at least one form of contact
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 |
|---|---|---|
| PCT+2HOPEEach PCT+ group follows the same structure and starts with the group setting an agenda. Clients identify issues to work on using these steps: 1) Identify an issue and if/how it relates to their PTSD or substance use, 2) Brainstorm ideas that may help, 3) Evaluate how useful each idea is, and 4) Choose a plan. Clients are encouraged to implement and evaluate the effectiveness of the plan and share the outcome at their next group. At the end of the group, clients process their experiences of the discussion. HOPE is a flexible, module-based individual treatment where the ordering and emphasis of each module are determined by client priorities. HOPE is trauma-focused; clients relate their current symptoms to their experience of IPV, but do not process traumatic memories. Modules focus on 1) Establishing safety, providing information and skills that enhance empowerment, 2) Cognitive behavioral therapy skills, and 3) Improving relationships and establishing healthy boundaries. | Behavioural | PCT+2HOPE |
Primary outcome
Retention in MOUD treatment
Time frame: Week 26
Retention in MOUD treatment at week 26. This will be measured through a combination of self-report with objective confirmation (e.g., via electronic health record, provider-confirmed treatment engagement/retention, medication bottles, urine toxicology testing).
7 secondary outcomes
PTSD-related impairment in psychosocial functioning
Time frame: Week 26
Opioid use disorder symptom severity
Time frame: Week 26
Days of extra-medical opioid use, past 30 days
Time frame: Week 26
Urine test positive for opioid use
Time frame: Week 26
Depression symptom severity
Time frame: Week 26
Recovery
Time frame: Week 26
Empowerment
Time frame: Week 26
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 16 Jul 2026.
- BackgroundJohnson DM, Zlotnick C, Gonzalez A. Treatment of Post-traumatic Stress Disorder in Survivors of Intimate Partner Violence. Handbook of Interpersonal Violence and Abuse Across the Lifespan: A project of the National Partnership to End Interpersonal Violence Across the Lifespan (NPEIV). 2021:3223-3246.
- Background: PubMed 30611302Moullin JC, Dickson KS, Stadnick NA, Rabin B, Aarons GA. Systematic review of the Exploration, Preparation, Implementation, Sustainment (EPIS) framework. Implement Sci. 2019 Jan 5;14(1):1. doi: 10.1186/s13012-018-0842-6.
- Background: PubMed 36370469Morse AK, Sercombe J, Askovic M, Fisher A, Marel C, Chatterton ML, Kay-Lambkin F, Barrett E, Sunderland M, Harvey L, Peach N, Teesson M, Mills KL. Systematic review of the efficacy, effectiveness, and cost-effectiveness of stepped-care interventions for the prevention and treatment of problematic substance use. J Subst Abuse Treat. 2023 Jan;144:108928. doi: 10.1016/j.jsat.2022.108928. Epub 2022 Nov 4.
- Background: PubMed 32021588Carroll KM, Weiss RD. The Role of Behavioral Interventions in Buprenorphine Maintenance Treatment: A Review. Focus (Am Psychiatr Publ). 2019 Apr;17(2):183-192. doi: 10.1176/appi.focus.17206. Epub 2019 Apr 10.
- Background: PubMed 27459503Johnson DM, Johnson NL, Perez SK, Palmieri PA, Zlotnick C. Comparison of Adding Treatment of PTSD During and After Shelter Stay to Standard Care in Residents of Battered Women's Shelters: Results of a Randomized Clinical Trial. J Trauma Stress. 2016 Aug;29(4):365-73. doi: 10.1002/jts.22117. Epub 2016 Jul 26.
- Background: PubMed 34305273Johnson DM, Palmieri PA, Zlotnick C, Johnson NL, Hoffman L, Holmes SC, Ceroni TL. A Randomized Controlled Trial Comparing HOPE Treatment and Present-Centered Therapy in Women Residing in Shelter with PTSD from Intimate Partner Violence. Psychol Women Q. 2020 Dec 1;44(4):539-553. doi: 10.1177/0361684320953120. Epub 2020 Sep 17.
- Background: PubMed 17327524Schnurr PP, Friedman MJ, Engel CC, Foa EB, Shea MT, Chow BK, Resick PA, Thurston V, Orsillo SM, Haug R, Turner C, Bernardy N. Cognitive behavioral therapy for posttraumatic stress disorder in women: a randomized controlled trial. JAMA. 2007 Feb 28;297(8):820-30. doi: 10.1001/jama.297.8.820.
- Background: PubMed 31742672Belsher BE, Beech E, Evatt D, Smolenski DJ, Shea MT, Otto JL, Rosen CS, Schnurr PP. Present-centered therapy (PCT) for post-traumatic stress disorder (PTSD) in adults. Cochrane Database Syst Rev. 2019 Nov 18;2019(11):CD012898. doi: 10.1002/14651858.CD012898.pub2.
- Background: PubMed 28237054Butner JL, Gupta N, Fabian C, Henry S, Shi JM, Tetrault JM. Onsite treatment of HCV infection with direct acting antivirals within an opioid treatment program. J Subst Abuse Treat. 2017 Apr;75:49-53. doi: 10.1016/j.jsat.2016.12.014. Epub 2017 Jan 24.
- Background: PubMed 34098298Ngo BV, James JR, Blalock KL, Jackson SL, Chew LD, Tsui JI. Hepatitis C treatment outcomes among patients treated in co-located primary care and addiction treatment settings. J Subst Abuse Treat. 2021 Dec;131:108438. doi: 10.1016/j.jsat.2021.108438. Epub 2021 Apr 29.
- Background: PubMed 30882491Oldfield BJ, Munoz N, McGovern MP, Funaro M, Villanueva M, Tetrault JM, Edelman EJ. Integration of care for HIV and opioid use disorder. AIDS. 2019 Apr 1;33(5):873-884. doi: 10.1097/QAD.0000000000002125.
- Background: PubMed 30797400Bailey K, Trevillion K, Gilchrist G. What works for whom and why: A narrative systematic review of interventions for reducing post-traumatic stress disorder and problematic substance use among women with experiences of interpersonal violence. J Subst Abuse Treat. 2019 Apr;99:88-103. doi: 10.1016/j.jsat.2018.12.007. Epub 2018 Dec 24.
- Individual participant dataSharing planned: Yes. De-identified study data and associated documentation will be made available to the research community free of charge through the Inter-university Consortium for Political and Social Research (ICPSR), which has been approved as a HEAL-compliant data repository.
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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.
Tami Sullivan, PhD principal investigator
Yale University
E. Jennifer Edelman, MD, MHS, AAHIVS principal investigator
Yale University
Dawn Johnson, PhD principal investigator
The University of Akron
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PCT+2HOPE in people with Opioid Use Disorder and Intimate Partner Violence (IPV), run by Yale University at 3 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 10 inclusion and 5 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 16 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 3 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?
Contact Tami Sullivan, PhD (203-789-7645, tami.sullivan@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retention in MOUD treatment (time frame: Week 26). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07115030, which also lists 18 linked publications.
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 16 Jul 2026; AzTrials last refreshed its copy on 7 Nov 2026.